qanastek/EMEA-V3 huggingface dataset:
108 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
111 jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma ’ produzzjoni għolja ta ’ l - ormon aldosterone, li jikkawża retenzjoni ta ’ sodium u, li min- naħa tiegħu, iżid il- pressjoni fid - demm).
109 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu CoAprovel malli ssir taf li inti ħriġt tqila.
If you get any of these symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
113 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf CoAprovel u għid lit - tabib tiegħek minnufih.
110 The frequency of the side effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti sekondarji elenkati hawn taħt hija definita bl- użu tal- konvenzjoni segwenti:
Do not store above 30°C.
114 Taħżinx f’ temperatura ’ l fuq minn 30°C.
111 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each film-coated tablet of CoAprovel 300 mg/ 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ CoAprovel 300 mg/ 12. 5 mg fiha 300 mg irbesartan u 12. 5 mg hydrochlorothiazide.
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/ 12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Id- dehra ta ’ CoAprovel u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita CoAprovel 300 mg/ 12. 5 mg huma lewn il- ħawħa, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2876 fuq in- naħa l- oħra.
CoAprovel 300 mg/ 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita CoAprovel 300 mg/ 12. 5 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
112 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
115 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
114 PACKAGE LEAFLET:
117 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER CoAprovel 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU CoAprovel 300 mg/ 25 mg pilloli miksijin b' rita. irbesartan/ hydrochlorothiazide
115 if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
118 jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) jekk issofri minn aldosteroniżmu primarju (kundizzjoni relatata ma ’ produzzjoni għolja ta ’ l - ormon aldosterone, li jikkawża retenzjoni ta ’ sodium u, li min- naħa tiegħu, iżid il- pressjoni fid - demm).
116 Your doctor will normally advise you to stop taking CoAprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu CoAprovel malli ssir taf li inti ħriġt tqila.
If you get any of these symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
120 Jekk ikollok xi sintomu minn dawn jew tesperjenza qtugħ ta ’ nifs, waqqaf CoAprovel u għid lit - tabib tiegħek minnufih.
117 The frequency of the side effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti sekondarji elenkati hawn taħt hija definita bl- użu tal- konvenzjoni segwenti:
Do not store above 30°C.
121 Taħżinx f’ temperatura ’ l fuq minn 30°C.
118 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Each film-coated tablet of CoAprovel 300 mg/ 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Kull pillola miksija b' rita ta ’ CoAprovel 300 mg/ 25 mg fiha 300 mg irbesartan u 25 mg hydrochlorothiazide.
The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinized starch, carnauba wax.
Is- sustanzi l- oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, ferric oxides ħomor, sofor u suwed, lamtu preġelatinizzat, carnauba wax.
What CoAprovel looks like and contents of the pack CoAprovel 300 mg/ 25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Id- dehra ta ’ CoAprovel u l- kontenuti tal- pakkett Il- pilloli miksijin b' rita CoAprovel 300 mg/ 25 mg huma roża, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb ibbuzzata fuq naħa waħda u n- numru 2788 fuq in- naħa l- oħra.
CoAprovel 300 mg/ 25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Il- pilloli miksijin b' rita CoAprovel 300 mg/ 25 mg huma fornuti fi strixxi ta '14, 28, 30, 56, 84, 90 jew 98 pillola miksija b' rita.
119 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
122 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
120 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
123 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Combivir?
X’ inhu Combivir?
Combivir is a medicine that contains two active substances, lamivudine (150 mg) and zidovudine (300 mg).
Combivir huwa mediċina li fiha żewġ sustanzi attivi, lamivudine (150 mg) u zidovudine (300 mg).
It is available as white capsule-shaped tablets.
Huwa disponibbli bħala pilloli f’ għamla ta ’ kapsuli ta ’ lewn abjad.
What is Combivir used for?
Għal xiex jintuża Combivir?
Combivir is an antiviral medicine.
Combivir huwa mediċina antivirali.
It is used in combination with at least one other antiviral medicine to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Huwa jintuża flimkien ma ’ ta ’ lanqas mediċina antivirali oħra biex jittratta pazjenti li huma infettati bil- virus ta ’ immunodefiċjenza umana (HIV), il- virus li jikkaġuna s- sindromu minn immunodefiċjenza akkwiżita (AIDS).
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta.
How is Combivir used?
Kif jintuża Combivir?
Treatment with Combivir should be initiated by a doctor who has experience in the management of HIV infection.
It- trattament b’ Combivir għandu jinbeda minn tabib li għandu esperjenza fil- ġestjoni ta ’ infezzjonijiet bl- HIV.
In adults and adolescents weighing at least 30 kg, the recommended dose of Combivir is one tablet taken twice a day.
Id- doża rakkomandata ta ’ Combivir f’ adulti u adolexxenti li jiżnu mill- anqas 30 kg, hi ta ’ pillola waħda darbtejn kuljum.
In children weighing between 14 and 30 kg, the number of tablets and half tablets to take depends on body weight.
Fi tfal li jiżnu bejn 14 u 30 kg, l- għadd ta ’ pilloli, sħaħ jew f’ nofs, jiddependi fuq il- piż tal- ġisem.
Children weighing less than 14 kg will need to use separate oral solutions containing lamivudine and zidovudine.
Tfal li jiżnu anqas minn 14 kg għandhom jużaw soluzzjonijiet orali separati li fihom lamivudine u zidovudine.
Children taking Combivir should be closely monitored for side effects.
Tfal li jieħdu Combivir għandhom jiġu osservati mill- qrib għal effetti sekondarji.
Combivir can be taken with or without food.
Combivir jista ’ jiġi meħud ma ’ l- ikel jew fuq stonku vojt.
The tablets should ideally be swallowed without crushing, although patients who cannot swallow tablets may crush and add them to a small amount of food or drink, before taking the dose immediately.
Il- pilloli għandhom jinbelgħu mingħajr ma jitfarrku, minkejja li pazjenti li ma jistgħux jibilgħu pilloli jistgħu jfarrkuhom u jżiduhom ma ’ ammont żgħir ta ’ ikel jew xorb, dritt qabel ma jieħdu d- doża.
If patients need to stop taking lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing lamivudine or zidovudine separately.
Jekk il- pazjenti jkollhom bżonn jieqfu jieħdu lamivudine jew zidovudine, jew jeħtieġu jieħdu dożi differenti minħabba problemi bil- kliewi, il- fwied, jew id- demm tagħhom, ikun meħtieġ li jieħdu l- mediċini li fihom lamivudine jew zidovudine separatament.
For more information, see the Package Leaflet.
Għal aktar tagħrif ara l- Fuljett ta ’ Tagħrif.
How does Combivir work?
Kif jaħdem Combivir?
Both active substances in Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Iż- żewġ sustanzi attivi f’ Combivir, lamivudine u zidovudine, huma inibitur nukleosidiku tat - traskrittażi inversa (nucleoside reverse transcriptase inhibitor NRTI).
Combivir, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
It- tnejn li huma jaħdmu b’ mod simili billi jimblokkaw l- attività tat- traskrittażi inversa, enzima li hija prodotta permezz ta ’ l- HIV li tippermettiha li tinfetta ċ- ċelloli u tiġġenera aktar virusis.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Combivir, meta jittieħed f’ kombinazzjoni ma ’ ta ’ l- anqas mediċina antiretrovirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Faks (44- 20) 74 18 84 16 Ittre: mail@ emea. europa. eu http: // www. emea. europa. eu
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. baxx.
How has Combivir been studied?
Kif ġie studjat Combivir?
Because zidovudine has been available in the European Union (EU) since the mid-1980s, and lamivudine has been approved in the EU since 1996 as Epivir, the company presented information obtained in earlier studies of the two substances taken together.
Peress li zidovudine ilu disponibbli fl- Unjoni Ewropea (UE) sa min- nofs it- tmeninijiet, u lamivudine ġie approvat fl- UE fl- 1996 bħala Epivir, il- kumpanija ppreżentat tagħrif miksub minn studji li saru fi żmien aktar bikri dwar iż- żewġ sustanzi meta ttieħdu flimkien.
The company also compared the combination tablet to separate tablets of lamivudine and zidovudine in 75 adults and adolescents who had not taken treatment for HIV infection before.
Il- kumpanija qabblet ukoll il- pillola kkombinata ma ’ pilloli separati ta ’ lamivudine u zidovudine f’ 75 adult u adolexxenti inkonsapevoli mit- trattament li ma kinux ħadu trattament għal HIV qabel.
The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and the change in the number of CD4 T-cells in the blood (CD4 cell count) after 12 weeks of treatment.
Il- kejl ewlieni ta ’ l- effikaċja kienu l- bidliet fil- livelli ta ’ HIV fid- demm (viral load) u l- bidla fl- għadd ta ’ ċelloli- T CD4 fid- demm (għadd ta ’ ċelloli CD4) wara 12- il ġimgħa ta ’ trattament.
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Iċ- ċelloli- T CD4 huma ċelloli tad- demm bojod li huma importanti fil- ġlieda kontra l- infezzjonijiet, imma li huma maqtula bl- HIV.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Il- kumpanija rat ukoll il - mod kif il- pillola kkombinata kienet assorbita fil- ġisem meta mqabbla mal- pilloli separati.
In order to support its recommendations for Combivir doses in children, the company presented information from studies of the levels of lamivudine and zidovudine in the blood of children taking the medicines separately.
Sabiex jiġu sostenuti r- rakkomandazzjonijiet għad- dożi ta ’ Combivir fit- tfal, il- kumpanija ppreżentat informazzjoni minn studji tal- livelli tal- lamivudine u z- zidovudine fid- demm tat- tfal li jieħdu l - mediċina separatament.
It also presented information on the predicted blood levels of the two substances in children taking the two substances combined in one tablet.
Hija ppreżentat ukoll informazzjoni dwar il- livelli tad- demm previsti taż- żewġ sustanzi fi tfal li jieħdu ż- żewġ sustanzi kkumbinati f’ pillola waħda.
What benefit has Combivir shown during the studies?
X’ benefiċċju wera Combivir matul l- istudji?
Combivir was effective at reducing viral loads and allowing CD4 cell counts to rise.
Combivir kien effikaċi biex inaqqas il- viral load u jippermetti li l- għadd ta ’ ċelloli CD4 jiżdied.
The earlier studies showed that the active substances, lamivudine and zidovudine, taken together could reduce viral loads and allow CD4 cell counts to rise after up to one year of treatment.
L- istudji aktar bikrija wrew li s- sustanzi attivi, lamivudine u zidovudine, meta meħuda flimkien jistgħu jnaqqsu l- viral load u jippermettu l- għadd ta ’ ċelloli CD4 biex jiżdied sa wara sena ta ’ trattament.
In the new study, patients taking Combivir and those taking the two active substances separately had similar falls in viral load.
Fl- istudju l- ġdid, il- pazjenti ttrattati b’ Combivir u dawk ittrattati biż- żewġ sustanzi separatament kellhom tnaqqis simili fil- viral load.
After 12 weeks, the viral load had fallen by more than 95%.
Wara 12- il ġimgħa, il- viral load kienet niżlet b’ aktar minn 95%.
The two groups also had similar rises in CD4 cell counts.
Iż- żewġ gruppi kellhom l- istess tkabbir fl- għadd ta ’ ċelloli CD4.
The combination tablet was absorbed in the body in the same way as the separate tablets.
Il- pillola kkombinata kienet assorbita fil- ġisem bl- istess mod bħal ma ’ pilloli separati.
In addition, the recommended doses of Combivir in children produced similar levels of the two active substances as in adults.
Barra minn hekk, id- dożi ta ’ Combivir rrakkommandati fit- tfal għamlu l- istess livelli taż- żewġ sustanzi attivi bħal fl- adulti.
What is the risk associated with Combivir?
X’ inhu r- riskju assoċjat ma ’ Combivir?
The most common side effects when taking Combivir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
L- aktar effetti sekondarji komuni waqt it- teħid ta ’ Combivir (li jidhru f’ aktar minn pazjent 1 f’ 10) huma dijarrea u nawżea (dardir).
For the full list of all side effects reported with Combivir, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Combivar, ara l- Fuljett ta ’ Tagħrif.
Combivir should not be used by people who may be hypersensitive (allergic) to lamivudine, zidovudine or any of the other ingredients.
Combivir m’ għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal lamivudine, zidovudine jew għal xi wieħed mis- sustanzi l- oħra.
Because it contains zidovudine, it should also not be used by patients with low neutrophil counts (a type of white blood cell) or anaemia (low red blood cell counts).
Minħabba li fih zidovudine, m’ għandux jintuża minn pazjenti li għandhom għadd baxx ta ’ newtrofili (tip ta ’ ċelloli bojod tad- demm) jew anemija (livelli baxxi ta ’ ċelloli ħomor tad- demm).
Combivir should not be taken with some other medicines.
Combivir m’ għandux jintuża ma ’ xi mediċini oħra.
See the Package Leaflet for more information.
Ara l - Fuljett ta ’ Tagħrif għal aktar informazzjoni.
As with other anti-HIV medicines, patients taking Combivir may be at risk of developing lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta ’ mediċini ta ’ kontra l- HIV, pazjenti li jieħdu Combivir jistgħu jkunu f’ riskju li jiżviluppaw lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fil- ġisem), osteonekrosi (mewt tat- tessut ta ’ l- għadam) jew sindrome ta ’ riattivazzjoni immunitarja (sintomi ta ’ l- infezzjoni kkawżati bis- sistema immunitarja li tkun qiegħda tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Combivir.
Pazjenti li għandhom problemi bil- fwied tagħhom (inkluż infezzjoni bl- epatite B jew Ċ) jistgħu jkunu f’ riskju ogħla ta ’ ħsara meta jkunu qed jieħdu Combivir.
As with all other NRTIs, Combivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Combivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal fil- każ ta ’ NRTIs oħra, Combivir jista ’ jikkaġuna wkoll aċidożi lattika (il- ġbir ta ’ l - aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet li jieħdu Combivir waqt it- tqala, disfunzjoni mitokondrijali (ħsara fil- komponenti li jipproduċu l- enerġija fi ħdan ċelloli li jistgħu jikkawżaw problemi fid- demm).
Why has Combivir been approved?
Għaliex ġie approvat Combivir?
The Committee for Medicinal Products for Human Use (CHMP) decided that Combivir’ s benefits are greater than its risks in antiretroviral combination therapy for the treatment of HIV infection.
Il- Kumitat dwar il- Prodotti Mediċini għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Combivir huma ogħla mir- riskji tiegħu f’ terapija ta ’ kombinazzjoni retrovirali fit- trattament f’ dawk infettati bl- HIV.
The Committee recommended that Combivir be given marketing authorisation.
Il- Kumitat irrakkomanda li Combivir għandu jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Combivir:
2/ 3 Aktar tagħrif dwar Combivir:
The European Commission granted a marketing authorisation valid throughout the EU for Combivir to Glaxo Group Ltd on 18 March 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Combivir lil Glaxo Group Ltd fit- 18 ta ’ Marzu 1998.
The marketing authorisation was renewed on 18 March 2003 and on 18 March 2008.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 18 ta ’ Marzu 2003.
The full EPAR for Combivir is available here.
L- EPAR sħiħ dwar Combivir jista ’ jiġi kkonsultat hawn.
Combivir 150 mg/ 300 mg film-coated tablets
Combivir 150mg/ 300mg pilloli miksijin b' rita
Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine.
Kull pillola miksija b' rita jkun fiha 150 mg lamivudine u 300 mg zidovudine
For a full list of excipients see section 6.1.
Għal lista sħiħa ta ’ sustanzi mhux attivi ara taqsima 6. 1
White to off-white, capsule-shaped film-coated scored tablets engraved with “ GXFC3” on both sides.
Pilloli miksijin b' rita, f’ forma ta 'kapsula ta' lewn abjad jagħti fl- offwajt u b’ GXFC3 inċiż fuq iż- żewġ naħat.
Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2).
Combivir huwa indikat għal terapija antiretrovirali kombinata għall- kura ta 'adulti u adolexxenti ta' 'l fuq minn 12- il sena kontra l- Virus ta' l- Immunodefiċjenza fil- Bniedem (HIV) (ara sezzjoni 4. 2).
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib ta 'esperjenza fil- kura ta' l- infezzjoni HIV.
Combivir may be administered with or without food.
Combivir jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Biex il- pazjent ikun sgur li jieħu l- pillola kollha, għandu idealment jiblagħha sħiħa Għal pazjenti li ma jistgħux jibilgħu pilloli, il- pilloli jistgħu ikunu mfarrka u miżjuda ma ’ ammont żgħir ta ’ ikel semi - solidu jew likwidu, u jittieħdu kollha minnufih (ara sezzjoni 5. 2)
Adults and adolescents weighing at least 30 kg: the recommended dose of Combivir is one tablet twice daily.
Adulti u adolexxenti li jiżnu mill- anqas 30kg: id- doża rrakkomandata ta 'Combivir hi ta' pillola waħda darbtejn kuljum.
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.
Tfal li jiżnu bejn il- 21kg u t- 30kg: id- doża orali ta ’ COMBIVIR irrakomandata hija ta ’ nofs pillola filgħodu u pillola sħiħa filgħaxija.
Children weighing from 14 kg to 21 kg: the recommended oral dose of COMBIVIR is one-half tablet taken twice daily.
Tfal li jiżnu bejn l- 14kg u 21kg: id- doża orali ta ’ COMBIVIR irrakomandata hija ta ’ nofs pillola darbtejn kuljum.
The dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling and supported by data from clinical studies using the individual components lamivudine and zidovudine.
Is- sistema ta ’ dożaġġ għal pazjenti pedjatriċi li jiżnu bejn 14 u 30kg hija bbażata primarjament fuq mudell farmakokinetiku u msaħħaħ minn data minn studji kliniċi fejn intużaw il- komponenti individwali lamivudine u zidovudine.
A pharmacokinetic overexposure of zidovudine can occur, therefore close safety monitoring is warranted in these patients.
Tista ’ ssir espożizzjoni żejda farmakokinetika, u għalhekk hija meħtieġa sorveljanza mill- qrib f’ dawn il- pazjenti.
If gastrointestinal intolerance occurs in patients weighing 21-30 kg, an alternative dosing schedule with one-half tablet taken thrice daily can be applied in attempt to improve tolerability.
Jekk ikun hemm intolleranza gastrointestinali f’ pazjenti li jiżnu minn 21- 30kg, tista ’ tintuża skeda alternattiva ta ’ dożaġġ b’ nofs pillola tlett darbiet kuljum bi prova biex titjieb it- tolleranza.
Combivir tablets should not be used for children weighing less than 14 kg, since doses can not be appropriately adjusted for the weight of the child.
Il- pilloli ta ’ Combivir m’ għandhomx jintużaw fi tfal li jiżnu anqas minn 14kg minħabba li d- dożi ma jistgħux ikunu aġġustati b’ mod xieraq għal piż tat- tifel/ tifla.
In these patients, lamivudine and zidovudine should be taken as separate formulations according to the prescribed dosing recommendations for these products.
F’ dawn il- pazjenti, lamivudine u zidovudine għandhom jingħataw bħala formulazzjonijiet separati skond ir- rakkomandazzjonijiet ta ’ dożaġġ preskritti għal dawn il- prodotti.
For these patients and for patients, who are unable to swallow tablets, oral solutions of lamivudine and zidovudine are available.
Għal dawn il- pazjenti u għal pazjenti li ma jistgħux jibilgħu
2 For situations where discontinuation of therapy with one of the active substances of Combivir, or dose reduction is necessary separate preparations of lamivudine and zidovudine are available in tablets/ capsules and oral solution.
2 pilloli, hemm is- soluzzjonijet orali ta ’ lamivudine u zidovudine.
Lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance.
Il- konċentrazzjonijiet ta 'lamivudine u zidovudine jiżdiedu f' pazjenti b' indeboliment tal- kliewi minħabba tneħħija mill- ġisem imnaqqsa.
Therefore as dosage adjustment of these may be necessary it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with reduced renal function (creatinine clearance ≤ 50 ml/ min).
Għalhekk, billi jista ’ jkun meħtieġ tibdil fid- doża hu rrakkomandat li pazjenti b' funzjoni batuta tal- kliewi (tneħħija tal- krejatinina ≤50 ml/ min) jingħataw preparazzjonijiet separati ta 'lamivudine u zidovudine.
Physicians should refer to the individual prescribing information for these medicinal products.
It- tobba għandhom jirreferu għal informazzjoni dwar kif għandhom jiġu preskritti dawn il- prodotti mediċinali individwali.
Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation.
Informazzjoni limitata dwar pazjenti li jbatu minn ċirrożi tindika li jista ’ jkun hemm akkumulazzjoni ta 'lamivudine f' pazjenti b' indeboliment tal- fwied minħabba li l - glukuronidazzjoni tkun imnaqqsa.
Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Informazzjoni miksuba minn pazjenti b' indeboliment moderat jew sever tal- fwied turi li l- farmakokinetika ta ’ lamivudine mhix mibdula b’ mod sinifikanti meta jkun hemm indeboliment tal- fwied.
However, as dosage adjustments for zidovudine may be necessary, it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with severe hepatic impairment.
Madankollu, billi jista ’ jkun hemm il- ħtieġa ta 'tibdil fid- dożi ta ’ zidovudine, hu rrakkomandat li pazjenti b' indeboliment sever tal- fwied jingħataw preparazzjonijiet separati ta' lamivudine u zidovudine.
Physicians should refer to the individual prescribing information for these medicinal products.
It- tobba għandhom jirreferu għal informazzjoni dwar kif għandhom jiġu preskritti dawn il- prodotti mediċinali individwalment.
Dosage adjustments in patients with haematological adverse reactions:
Tibdil fid- dożi f 'pazjenti b' reazzjonijiet ematoloġiċi severi:
Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/ dl or 5.59 mmol/ l or the neutrophil count falls below 1.0 x 109/ l (see sections 4.3 and 4.4).
Tibdil fid- dożaġġ ta 'zidovudine jista ’' jkun meħtieġ jekk il- livelli ta 'emoglobina jitbaxxew għal inqas minn 9 g/ dl jew 5. 59 mmol/ l jew jekk l- għadd tan- newtrofili jitbaxxa għal inqas minn 1. 0 x 109/ l (ara taqsimiet 4. 3 u 4. 4).
As dosage adjustment of Combivir is not possible, separate preparations of zidovudine and lamivudine should be used.
Billi tibdil fid - dożaġġ ta ’ Combivir mhux possibbli, għandhom jintużaw preparazzjonijiet separati ta ’ zidovudine u l - lamivudine.
Dosage in the elderly:
Dożaġġ għall- anzjani:
No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
M’ hemmx informazzjoni partikolaru disponibbli, iżda għal din il- kategorija trid tingħata attenzjoni speċjali minħabba bidliet assoċjati ma 'l- eta' bħal tnaqqis fil- funzjoni tal- kliewi u tibdil ta 'parametri ematoloġiċi.
Hypersensitivity to the active substances or to any of the excipients.
Sensittivita 'eċċessiva għas- sustanzi attivi jew għal xi waħda mis- sustanzi mhux attivi.
Zidovudine is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 109/ l), or abnormally low haemoglobin levels (< 7.5 g/ dl or 4.65 mmol/ l).
Zidovudine m' għandux jingħata lil pazjenti b' għadd baxx ta 'newtrofili (< 0. 75 x 109/ l), jew b' livelli baxxi aktar min- normal ta' emoglobina (< 7. 5g/ dl jew 4. 65mmol/ l).
Combivir is therefore contra- indicated in these patients (see section 4.4).
Għalhekk Combivir m' għandux jingħata lil dawn il- pazjenti (ara taqsima 4. 4).
The special warnings and precautions relevant to both lamivudine and zidovudine are included in this section.
It- twissijiet u l- prekawzjonijiet speċjali li għandhom x’ jaqsmu kemm ma ’ lamivudine kif ukoll ma ’ zidovudine huma inklużi f' din it- taqsima.
There are no additional precautions and warnings relevant to the combination Combivir.
M' hemmx prekawzjonijiet u twissijiet oħra dwar it- taħlita ta ’ Combivir.
It is recommended that separate preparations of lamivudine and zidovudine should be administered in cases where dosage adjustment is necessary (see section 4.2).
Hu rrakkomandat li jingħataw preparazzjonijiet separati ta 'lamivudine u zidovudine meta jkun meħtieġ xi tibdil fid- dożaġġ (ara taqsima 4. 2).
In these cases the physician should refer to the individual prescribing information for these medicinal products.
F' dawn il- każi t- tabib irid jirreferi għal informazzjoni dwar kif għandhom jiġu preskritti dawn il- prodotti mediċinali individwali.
The concomitant use of stavudine with zidovudine should be avoided (see section 4.5).
Għandu jkun evitat l- użu ta ’ stavudine u zidovudine flimkien (ara taqsima 4. 5).
Opportunistic infections:
Infezzjonijiet Opportunistiċi:
Patients receiving Combivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection.
Pazjenti li jkunu qed jieħdu Combivir jew xi terapija oħra antiretrovirali jistgħu jaqbduhom infezzjonijiet opportunistiċi u kumplikazzjonijiet oħra ta 'l- infezzjoni HIV.
Therefore patients should remain under close clinical observation by physicians experienced in the treatment of HIV infection.
Għalhekk il- pazjenti għandhom jibqgħu jiġu ssorveljati mill- qrib klinikament minn tobba b' esperjenza fil- kura ta 'l- infezzjoni HIV.
Patients should be advised that current antiretroviral therapy, including Combivir, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
3 Tixrid ta ’ HIV: Il- pazjenti għandhom ikunu avżati li t- terapija antiretrovirali li tintuża llum, inkluż Combivir, ma 'ġietx ippruvata li tneħħi r- riskju li tniġġes lil ħaddieħor bl- HIV permezz ta' kuntatt sesswali jew kontaminazzjoni bid- demm.
Appropriate precautions should continue to be taken.
Prekawzjonijiet xierqa għandhom jibqgħu jittieħdu.
3 Haematological adverse reactions:
Reazzjonijiet ematoloġiċi avversi:
Anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
Wieħed jista ’ jistenna li pazjenti li jieħdu zidovudine titfaċċalhom xi anemija, newtropenja u lewkopenja (normalment sekondarja għan- newtropenja).
These occurred more frequently at higher zidovudine dosages (1200-1500 mg/ day) and in patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease.
Dawn kienu aktar frekwenti b' dożaġġi ogħla ta 'zidovudine (1200 – 1500 mg/ kuljum) u f' pazjenti li kellhom riserva batuta tal- mudullun qabel ma bdew il- kura, speċjalment meta l- marda ta' l- HIV tkun daħlet 'il ġewwa.
Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Combivir.
Il- parametri ematoloġiċi għalhekk għandhom ikunu mmonitorjati mill- qrib (ara taqsima 4. 3) f' pazjenti li jkunu fuq Combivir.
These haematological effects are not usually observed before four to six weeks therapy.
Dawn l- effetti ematoloġiċi normalment ma jidhrux qabel erba 'jew sitt ġimgħat ta' terapija.
For patients with advanced symptomatic HIV disease, it is generally recommended that blood tests are performed at least every two weeks for the first three months of therapy and at least monthly thereafter.
Għal pazjenti b’ sintomi avanzati ta 'l- HIV, ġeneralment ikun rrakkomandat li jsiru testijiet tad- demm għall- inqas kull ġimgħatejn fl- ewwel tliet xhur tat- terapija u darba fix- xahar wara dan.
In patients with early HIV disease haematological adverse reactions are infrequent.
F' pazjenti bl- HIV li tkun għadha fil- bidu reazzjonijiet ematoloġiċi avversi mhumiex frekwenti.
Depending on the overall condition of the patient, blood tests may be performed less often, for example every one to three months.
Dejjem skond il- kundizzjoni ġenerali tal- pazjent, it- testijiet tad- demm jistgħu isiru inqas ta 'spiss, per eżempju darba kull xahar jew kull tliet xhur.
Additionally dosage adjustment of zidovudine may be required if severe anaemia or myelosuppression occurs during treatment with Combivir, or in patients with pre-existing bone marrow compromise e. g. haemoglobin < 9 g/ dl (5.59 mmol/ l) or neutrophil count < 1.0 x 109/ l (see section 4.2).
Barra minn hekk jista ’ jkun meħtieġ tibdil fid- doża ta ’ zidovudine jekk tiżviluppa xi anemija jew majelosuppressjoni qawwija waqt il- kura b’ Combivir, jew f' pazjenti bi problemi fil- mudullun e. ż emoglobina < 9 g/ dl (5. 59 mmol/ l) jew għadd ta 'newtrofili < 1. 0 x 109/ l (ara taqsima 4. 2).
As dosage adjustment of Combivir is not possible separate preparations of zidovudine and lamivudine should be used.
Billi d- dożaġġ ta ’ Combivir ma jistax jinbidel għandhom jintużaw preparazzjonijiet separati ta 'zidovudine u lamivudine.
Physicians should refer to the individual prescribing information for these medicinal products.
It- tobba għandhom jirreferu għall - informazzjoni dwar kif għandhom jiġu preskritti dawn il- prodotti mediċinali individwalment.
Pancreatitis:
Pankreatite:
Cases of pancreatitis have occurred rarely in patients treated with lamivudine and zidovudine.
Kien hemm każi rari ta 'pankreatite f' pazjenti li kienu qed jiġu kkurati b’ lamivudine u b’ zidovudine.
However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease.
Madanakollu, mhux ċar jekk dawn il- każi kienux dovuti għall- kura antiretrovirali jew għall- istess marda ta ’ l- HIV.
Treatment with Combivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Il- kura b’ Combivir għandha titwaqqaf minnufih jekk jitfaċċaw xi sinjali, sintomi jew anormalitajiet kliniċi li jindikaw pankreatite.
Lactic acidosis: lactic acidosis usually associated with hepatomegaly and hepatic steatosis has been reported with the use of nucleoside analogues.
Aċidożi lattika: l- aċidożi lattika, li normalment tkun assoċjata ma 'epatomegalija jew steatożi epatika, ġieli ġrat bl- użu ta' nuklejosidi analogi.
Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain) non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Sintomi tal- bidu (hyperlactatemia sintomatika) jinkludu sintomi beninni fid- diġestjoni (dardir, remettar u uġigħ ta, żaqq), telqa bla raġuni speċifika, nuqqas ta 'aptit, nuqqas fil- piż, sintomi respiratorji (nifs mgħaġġel u/ jew nifs qawwi) jew sintomi newroloġiċi (inkluż muskoli dgħajfa).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.
L- aċidożi lattika għandha mortalita 'għolja u tista' tiġi assoċjata ma 'pankreatite, nuqqas ta' funzjoni tal- fwied jew tal- kliewi.
Lactic acidosis generally occurred after a few or several months of treatment.
L- aċidożi lattika ġeneralment tfaċċat wara kura ta 'ftit xhur jew iżjed.
Treatment with nucleoside analogues should be discontinued if there is symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Il- kura b‘ analogi nuklejosidi għandha titwaqqaf malli jidhru hyperlactatemia sintomatika u aċidożi metabolika/ lattika, epatomegalija progressiva, jew żjieda mgħaġġla fil- livelli ta 'l- aminotransferase.
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Għandha tingħata attenzjoni meta jingħataw l- analogi nuklejosidi lil pazjenti (partikolarment nisa ħoxnin) li jbatu minn epatomegalija, epatite jew fatturi oħra ta 'riskji magħrufa għal mard tal- fwied u steatożi epatika (inklużi xi prodotti mediċinali u alkoħol).
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Pazjenti ko- infettati bl- epatite C u li jkunu fuq kura bl- alpha interferon u ribavirin jistgħu ikunu f' riskju speċjali.
Patients at increased risk should be followed closely.
Pazjenti f' riskju qawwi għandhom ikunu taħt osservazzjoni stretta.
Mitochondrial dysfunction:
Disfunzjoni tal- mitokondrija:
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Analogi nukleosidi u nukleotidi jikkawżaw ħsara mitokondrjali varjabbli kemm in vitro u kemm in vivo.
There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/ or post-natally to nucleoside analogues.
Ġieli kien hawn każi ta 'funzjoni mitokondrjali ħażina fi trabi HIV - negative esposti għal analogi nukleosidiin utero u/ jew wara t- twelid.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
L- aktar effetti ħżiena rrappurtati huma mard fid- demm (anemija, newtropenja) u mard ta 'metaboliżmu (hyperlactataemia, hyperlipasaemia).
These events are often transitory.
Dawn huma effetti li jgħaddu.
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Ġew irrappurtati xi disturbi newroloġiċi li ma tfaċċawx mill- ewwel (hypertonia, aċċessjoni, imġiba mhux normali).
Whether the neurological disorders are transient or permanent is currently unknown.
Mhux magħruf jekk id- disturbi newroloġiċi humiex tal- mument jew permanenti.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV-negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Kull tarbija li ġiet esposta in utero għal analogi nukleosidi u nukleotidi, anki meta tkun HIV- negative, għandha tibqa 'tiġi ssorveljata klinikament u b’ testijiet f' laboratorju u għandha tkun investigata sew jekk jidhru xi sinjali jew sintomi rilevanti.
4 Lipodystrophy:
4 Dawn is- sejbiet m' għandhomx jaffettwaw ir- rakkomandazzjonijiet fis- seħħ lokalment dwar l- użu ta 'terapija antiretrovirali fil- każ ta' nisa tqal biex tiġi evitata t- trasmissjoni vertikali ta 'l- HIV.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
It- terapija kombinata antiretrovirali ġiet assoċjata ma 'distribuzzjoni mill- ġdid tax - xaħam tal- ġisem (lipodistrofija) f' pazjenti bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta 'dawn l- effetti fil- preżent mhumiex magħrufa.
Knowledge about the mechanism is incomplete.
Il- mekkaniżmu ta ’ dan mhux magħruf biżżejjed.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Hu maħsub li jista ’ jkun hemm ħolqa bejn lipomatożi tal- vixxri u inibituri tal- protease (Pis), u lipoatrofija u inibituri tar- reverse transcriptase b’ analogi nuklejosidi (NRTIs).
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju akbar ta 'lipodistrofija ġie assoċjat ma' fatturi individwali bħal eta 'aktar avanzata, u ma' fatturi relatati ma 'prodotti mediċinali bħal kura antiretrovirali aktar fit- tul u disturbi metaboliċi relatati.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi evalwazzjoni għal sinjali fiżiċi ta 'distribuzzjoni mill- ġdid ta' xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandhom jitkejlu l- lipidi fis- serum u tal - glukosju fid- demm wara sawma.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi tal- lipidi għandhom ikunu mmaniġġati kif jixraq klinikament (ara taqsima 4. 8).
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindromu ta ’ Rijattivazzjoni Immunitarja: f’ pazjenti infettati bl- HIV, b’ defiċjenza immunitarja severa fiż- żmien li tkun inbdiet it- terapija antiretrovirali kkombinata (TARK), jista ’ jkun hemm reazzjoni nfjammatorja bla sintomi għall- mikrobi opportunistiċi jew residwali li jwasslu għall- kundizzjonijiet kliniċi serji, jew li sintomi jmorru għall- agħar.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Dawn ir- reazzjonijiet ġew osservati l- aktar spiss fl - ewwel ftit ġimgħat jew xhur mill- bidu tat- TARK.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis jiroveci pneumonia (formerly known as Pneumocystis carinii pneumonia).
Eżempji rilevanti jinkludu retinite b ’ ċitomegalovirus, infezzjonijiet mikobatterjali lokali jew mifruxa, u pulmonite b’ Pneumocystis jiroveci li qabel kien magħruf bħala Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomi ta ’ nfammazzjoni għandhom ikunu studjati u t- trattament jinbeda fejn hemm bżonn.
Liver disease:
Mard tal- fwied:
If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SPC.
Jekk lamivudine ikun qed jintuża fl- istess ħin għal kura ta 'l- HIV u l- HBV, aktar tagħrif dwar l- użu ta ’ lamivudine għal kura ta ’ infezzjoni ta' l- epatite B jinsab fl- SPC ta ’ Zeffix.
The safety and efficacy of zidovudine has not been established in patients with significant underlying liver disorders.
Is- sigurta 'u l- effikaċja ta ’ zidovudine ma ġietx stabbilita f' pazjenti li jbatu b' mard tal- fwied.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Pazjenti bl- epatite kronika B jew Ċ li jkunu fuq terapija antiretrovirali kkombinata jkunu f' riskju akbar ta 'avvenimenti avversi serji u li jistgħu ikunu fatali.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Fil- każ li tkun qed tittieħed ukoll terapija antivirali fl- istess ħin għall- epatite B jew Ċ, jekk jogħġbok ara wkoll it- tagħrif relevanti dwar il - prodott għal dawn il- prodotti mediċinali.
If Combivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication for 4 months is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Jekk Combivir jitwaqqaf f' pazjenti ko- infettati bil- virus ta 'l- epatite B, huwa rrakkomandat monitoraġġ perijodiku ta' testijiet għal 4 xhur għall- funzjoni tal- fwied u sustanzi li juru r- replikazzjoni ta 'l- HBV, għaliex it- twaqqif ta ’ lamivudine jista ’ jikkawża li l- epatite tkompli tiħżien b’ mod akut (ara taqsima Zeffix SPC).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Pazjenti li kienu diġa 'jbatu b' disfunzjoni tal- fwied, inkluża l- epatite kronika attiva, ikollhom żieda fil - frekwenza ta' anormalitajiet fil- funzjoni tal- fwied waqt it- terapija kombinata antiretrovirali, u għandhom ikunu mmonitorjati bħas- soltu.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk f' dawn il- pazjenti jidhru xi sinjali li l- mard tal- fwied ikun sejjer għall- agħar, għandu wieħed jikkunsidrata li l- kura titwaqqaf għal ftit jew għal kollox.
Patients co-infected with hepatitis C virus:
Pazjenti infettati wkoll bil- vajrus ta 'l- epatite C:
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Mhuwiex rakkomandat l- użu flimkien ta ’ ribavirin ma ’ zidovudine minħabba riskju akbar ta ’ anemija (ara sezzjoni 4. 5)
Osteonecrosis:
Ostejonekrożi:
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Għalkemm il- kawża tista ’ tkun minħabba ħafna fatturi, (li jinkludu l- użu ta ’ kortikosterojdi, il- konsum ta ’ alkoħol, immunosuppressjoni qawwija, indiċi ogħla ta ’ piż tal- ġisem), każi ta ’ ostejonekrożi nstabu li huma partikolarment aktar komuni f’ pazjenti b’ HIVavvanzat u/ jew użu ta ’ terapija antiretrovirali kkombinata (TARK) fit- tul.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom ifittxu parir mediku jekk iħossu xi uġigħ jew ebusija fil- ġogi jew isibuha diffiċli biex jiċċaqalqu.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett terapewtiku tal- prodott.
As Combivir contains lamivudine and zidovudine, any interactions that have been identified with these agents individually may occur with Combivir.
Billi Combivir fih lamivudine u zidovudine, l- interazzjonijiet kollha li ġew identifikati ma 'dawn is - sustanzi individwalment jistgħu iseħħu wkoll ma ’ Combivir.
The likelihood of metabolic interactions with lamivudine is low due to limited metabolism and plasma protein binding, and almost complete renal clearance.
Il - possibbilta ’ ta ’ interazzjonijiet metaboliċi ma ’ lamivudine hi żgħira minħabba li l- metaboliżmu huwa limitat u l- għaqda mal - proteini tal- plażma, u t- tneħħija kważi totali mill- kliewi.
Zidovudine is primarily eliminated by hepatic conjugation to an inactive glucuronidated metabolite.
Zidovudine jitneħħa l- aktar bil- konjugazzjoni fil - fwied ma 'metabolit glukuronidat mhux attiv.
Medicinal products which are primarily eliminated by hepatic metabolism especially via glucuronidation may have the potential to inhibit metabolism of zidovudine.
5 permezz ta ’ metaboliżmu fil- fwied, speċjalment permezz ta 'glukuronidazzjoni, jistgħu ifixklu l - metaboliżmu ta ’ zidovudine.
The interactions listed below should not be considered exhaustive but are representative of the classes of medicinal products where caution should be exercised.
L- interazzjonijiet elenkati hawn taħt ma jkoprux il- lista kollha iżda jirrapreżentaw it- tipi ta 'prodotti mediċinali li għandhom jintużaw b' attenzjoni.