qanastek/EMEA-V3 huggingface dataset:
Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Preparazzjonijiet separati ta ’ abacavir jew lamivudine huma disponibbli f’ każi li fihom ikun indikat il- bżonn li titwaqqaf jew li tiġi aġġustata d- doża ta ’ waħda mis- sustanzi attivi.
In these cases the physician should refer to the individual product information for these medicinal products.
F’ dawn il- każi t- tabib għandu jirreferi għat- tagħrif dwar il- prodott individwali ta ’ dawn il- prodotti mediċinali.
2 Renal impairment:
2 Indeboliment renali:
Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/ min (see section 5.2).
Kivexa m’ huwiex rakkomandat għal użu f’ pazjenti b’ eliminazzjoni ta ’ krejatinina < 50 ml/ min (ara s- sezzjoni 5. 2).
Hepatic impairment:
Indebolimen tal- fwied:
No data are available in patients with moderate hepatic impairment, therefore the use of Kivexa is not recommended unless judged necessary.
M’ hemmx tagħrif dwar pazjenti b’ indeboliment moderat tal- fwied, għalhekk l- użu ta ’ Kivexa mhux rakkomandat sakemm ma jkunx ikkunsidrat neċessarju.
In patients with mild and moderate hepatic impairment close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see sections 4.4 and 5.2).
F’ pazjenti b’ indeboliment ħafif jew moderat tal- fwied ikun meħtieġ monitoraġġ sew, u jekk possibbli, hu rakkomandat il- monitoraġġ tal- livelli ta ’ abacavir fil- plażma (ara s- sezzjonijiet 4. 4 u 5. 2).
Kivexa is contraindicated in patients with severe hepatic impairment (see section 4.3).
Kivexa huwa kontra- indikat f’ pazjenti b’ indeboliment serju tal- fwied (ara s- sezzjoni 4. 3).
No pharmacokinetic data are currently available in patients over 65 years of age.
Ebda tagħrif farmakokinetiku ma jeżisti fil- preżent għal pazjenti ta ’ ’ l fuq minn 65 sena.
Special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Attenzjoni speċjali hi rakkomandata f’ dan il- grupp ta ’ nies minħabba tibdil assoċjat ma ’ l- eta` bħal tnaqqis fil- funzjoni tal- kliewi u tibdil ta ’ parametri ematoloġiċi.
Kivexa is not recommended for treatment of children less than 12 years of age as the necessary dose adjustment cannot be made.
Kivexa m’ huwiex rakkomandat fil- kura ta ’ tfal taħt it- 12- il sena billi l- aġġustament meħtieġ tad - doża ma jistax isir.
Kivexa is contraindicated in patients with known hypersensitivity to the active substances or to any of the excipients.
Kivexa huwa kontra- indikat f’ pazjenti li jbatu minn sensittività eċċessiva għas- sustanzi attivi jew għas- sustanzi mhux attivi.
See BOXED INFORMATION ON ABACAVIR HYPERSENSITIVITY REACTIONS in section 4.4 and section 4.8.
Ara L- KAXXA TA`L- INFORMAZZJONI FUQ REAZZJONIJIET TA ’ SENSITTIVITÀ EĊĊESSIVA GĦAL ABACAVIR f`sezzjonijiet 4. 4. u 4. 8.
Patients with severe hepatic impairment.
Kivexa m`għandux jingħata lill- pazjenti li jbatu minn indeboliment epatiku qawwi.
The special warnings and precautions relevant to abacavir and lamivudine are included in this section.
It- twissijiet u prekawzjonijiet speċjali dwar abacavir u lamivudine huma inklużi f’ din is- sezzjoni.
There are no additional precautions and warnings relevant to Kivexa.
M’ hemmx prekawzjonijiet u twissijiet oħra dwar Kivexa.
Hypersensitivity Reaction (see also section 4.8)
Reazzjoni ta ’ sensittività eċċessiva (ara wkoll sezzjoni 4. 8):
In clinical studies approximately 5% of subjects receiving abacavir develop a hypersensitivity reaction.
Fi studji kliniċi li saru nstab li bejn wieħed u ieħor 5% tal- pazjenti li ħadu abacavir żviluppaw reazzjonijiet ta ’ sensittività eċċessiva.
Some of these cases were life-threatening and resulted in a fatal outcome despite taking precautions.
Xi wħud minn dawn il- każijiet kienu ta` periklu għall- ħajja u kienu fatali minkejja li ttieħdu prekawzjonijiet.
Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir.
Studji urew li l- ġarr ta ’ l- allel HLA- B* 5701 huwa assoċjat ma ’ riskju ħafna aktar għoli ta ’ reazzjoni ta ’ sensittività eċċessiva għal abacavir.
Based on the prospective study CNA106030 (PREDICT- 1), use of pre-therapy screening for the HLA-B*5701 allele and subsequently avoiding abacavir in patients with this allele significantly reduced the incidence of abacavir hypersensitivity reactions.
Skond l- istudju prospettiv CNA106030 (PREDICT- 1), l- użu ta ’ investigazzjoni għal preżenza ta ’ l- allel HLA- B* 5701 qabel il- kura u li tevita l- użu ta ’ abacavir f’ pazjenti b’ dan l- allel, naqqas b’ mod sinifikanti ir- reazzjonijiet ta ’ sensittività eċċessiva għal abacavir.
In populations similar to that enrolled in the PREDICT-1 study, it is estimated that 48% to 61% of patients with the HLA-B*5701 allele will develop a hypersensitivity reaction during the course of abacavir treatment compared with 0% to 4% of patients who do not have the HLA-B*5701 allele.
Huwa stimat li minn 48% sa 61% tal- pazjenti bl- allel HLA- B* 5701 jiżviluppaw reazzjoni ta ’ sensittività eċċessiva waqt il- kors ta ’ kura b’ abacavir, f’ popolazzjonijiet simili għal dawk inklużi fl- istudu PREDICT- 1, meta mqabbla ma ’ 0% sa 4% ta ’ pazjenti li m’ għandhomx l- allel HLA- B* 5701.
These results are consistent with those of prior retrospective studies.
Dawn ir- riżultati huma konsistenti ma ’ dawk ta ’ studji retrospettivi li saru qabel.
As a consequence, before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
B’ konsegwenza ta ’ dan, qabel tibda l- kura b’ abacavir, għanda ssir investigazzjoni għall- ġarr ta ’ l- allel HLA- B* 5701 f’ kull pazjent infettat bl- HIV, irrispettivament mir- razza.
Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available based on the treatment history and resistance testing (see section 4.1).
Abacavir m’ għandux jintuża f’ pazjenti magħrufa li jġorru l- allel HLA- B* 5701, sakemm ma jkunx hemm l- ebda għażla oħra terapewtika f’ dawn il- pazjenti, fuq bażi ta ’ trattamenti ta ’ qabel u testijiet ta ’ reżistenza (ara sezzjoni 4. 1)
In any patient treated with abacavir, the clinical diagnosis of suspected hypersensitivity reaction must remain the basis of clinical decision-making.
F’ kull pazjent ttrattat b’ abacavir, id- dijanjożi klinika ta ’ reazzjoni ta ’ sensittività eċċessiva suspetta għandha tibqa il- bażi tad- deċiżjoni klinika.
It is noteworthy that among patients with a clinically suspected hypersensitivity reaction, a proportion did not carry HLA-B*5701.
Tajjeb li jiġi nnutat li f' pazjenti b' reazzjoni ta ’ sensittività eċċessiva suspettata klinikament, parti minnhom ma kienux qed iġorru l- allel HLA- B* 5701.
Therefore, even in the absence of HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential
Għalhekk, anke fl- assenza ta 'l- allel HLA- B* 5701, huwa mportanti li twaqqaf abacavir għal kollox u 3 ma terġax tibdieh jekk reazzjoni ta ’ sensittività eċċessiva ma ’ tistax tiġi eskluża fuq bażi kliniku, minħabba il- possibilita' ta 'reazzjoni serja jew inkella anke fatali.
Skin patch testing was used as a research tool for the PREDICT-1 study but has no utility in the clinical management of patients and therefore should not be used in the clinical setting.
Gew użati testijiet fuq roqgħa tal- ġilda bħala għodda ta ’ riċerka għall- istudju PREDICT- 1, madankollu ma kellhom l- ebda użu fl- imaniġġjar kliniku tal- pazjenti u għalhekk m’ għandhomx jintużaw fl- isfond kliniku.
• Clinical Description
• Deskrizzjoni Klinika
Hypersensitivity reactions are characterised by the appearance of symptoms indicating multi-organ system involvement.
Reazzjonijiet ta ’ sensittività eċċessiva huma karatteriżżati mid- dehra ta ’ sintomi li jinvolvu s- sistema ta ’ ħafna organi tal- ġisem.
Almost all hypersensitivity reactions will have fever and/ or rash as part of the syndrome.
Kważi r- reazzjonijiet kollha ta ’ sensittività eċċessiva jikkawżaw deni u/ jew raxx bħala parti mis- sindromu.
Other signs and symptoms may include respiratory signs and symptoms such as dyspnoea, sore throat, cough, and abnormal chest x-ray findings (predominantly infiltrates, which can be localised), gastrointestinal symptoms, such as nausea, vomiting, diarrhoea, or abdominal pain, and may lead to misdiagnosis of hypersensitivity as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
Sinjali u sintomi oħra jistgħu jinkludu sinjali u sintomi respiratorji bħall- qtugħ ta ’ nifs, uġigħ tal - griżem, sogħla kif ukoll riżultati anormali tal - x- rays tas- sider (il- parti l- kbira infiltrati, li jistgħu jkunu lokaliżżati), sintomi gastrointestinali, bħal dardir, rimettar, dijarrea, jew uġigħ addominali, u jistgħu jwasslu għal dijanjożi ħażina ta ’ sensittività eċċessiva bħal mard respiratorju (pulmonite, bronkite, farinġite), jew gastro- enterite.
Other frequently observed signs or symptoms of the hypersensitivity reaction may include lethargy or malaise and musculoskeletal symptoms (myalgia, rarely myolysis, arthralgia).
Sinjali u sintomi oħra li dehru fir- reazzjonijiet ta` sensittività eċċessiva jistgħu jinkludu letarġija jew telqa u sintomi muskolu- skeletali (mijalġja, rarament majlożi, artralġja).
The symptoms related to this hypersensitivity reaction worsen with continued therapy and can be life- threatening.
Is- sintomi relatati ma ’ din ir- reazzjoni ta` sensittività eċċessiva jaggravaw meta t- terapija titkompla u jistgħu jkunu ta` periklu għall- ħajja.
These symptoms usually resolve upon discontinuation of abacavir.
Dawn is- sintomi normalment ma jibqgħux jidhru meta jitwaqqaf abacavir.
• Clinical Management
• Maniġġar Kliniku
Hypersensitivity reaction symptoms usually appear within the first six weeks of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Is- sintomi tar- reazzjonijiet ta` sensittività eċċessiva normalment joħorġu fl- ewwel sitt ġimgħat mill - bidu tal- kura b`abacavir, għalkemm dawn ir- reazzjonijiet jistgħu joħorġu f`kull żmien matul it - terapija.
Patients should be monitored closely, especially during the first two months of treatment with abacavir, with consultation every two weeks.
Il- pazjenti għandhom ikunu monitorjati sew, b`mod speċjali matul l- ewwel xahrejn tal- kura b`abacavir, u għandhom imorru għand it- tabib għall- konsulta kull ġimgħatejn.
Patients who are diagnosed with a hypersensitivity reaction whilst on therapy MUST discontinue Kivexa immediately.
Pazjenti li jkollhom dijanjożi ta` reazzjoni ta` sensittività eċċessiva waqt it- terapija GĦANDHOM jieqfu jieħdu Kivexa immedjatament.
Kivexa, or any other medicinal product containing abacavir (Ziagen or Trizivir), MUST NEVER be restarted in patients who have stopped therapy due to a hypersensitivity reaction.
Ziagen jew Trizivir), M`GĦANDHA QATT terġa ’ tibda tingħata lill- pazjenti li jkunu waqqfu t- terapija minħabba sensittività eċċessiva.
Restarting abacavir following a hypersensitivity reaction results in a prompt return of symptoms within hours.
Jekk abacavir jerġa ’ jibda jingħata wara li jkun hemm reazzjonijiet ta` sensittività eċċessiva, l- istess sintomi jerġgħu joħorġu wara ftit sigħat.
This recurrence is usually more severe than on initial presentation, and may include life-threatening hypotension and death.
Din ir- rikkorrenza normalment tkun aktar severa mill- ewwel waħda, u tista tinkludi pressjoni baxxa li tkun ta ’ periklu għall- ħajja kif ukoll tista twassal għal mewt.
To avoid a delay in diagnosis and minimise the risk of a life-threatening hypersensitivity reaction, Kivexa must be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medicinal products).
Sabiex tevita dewmien tad- dijanjożi u tnaqqas ir- riskju ta` reazzjoni ta` sensittività eċċessiva ta` periklu għall- ħajja, Kivexa għandha titwaqqaf għal dejjem kif ikun hemm dubju ta ’ sensittività eċċessiva, anki meta jkun hemm possibiltà ta` dijanjożi oħra (mard respiratorju, mard simili għal dak ta` l- influwenza, gastro- enterite jew reazzjonijiet għal mediċini oħra).
Special care is needed for those patients simultaneously starting treatment with Kivexa and other medicinal products known to induce skin toxicity (such as non-nucleoside reverse transcriptase inhibitors - NNRTIs).
Għandha tingħata attenzjoni speċjali lill- pazjenti li jibdew kura b` Kivexa flimkien ma ’ kura bi prodotti mediċinali oħra li huma magħrufa li jikkawżaw tossiċità fil- ġilda (bħall- inibituri tar- reverse transcriptase li mhumiex nukloesidi - NNRTIs).
This is because it is currently difficult to differentiate between rashes induced by these products and abacavir related hypersensitivity reactions.
Dan minħabba l- fatt li fil- preżent huwa diffiċli sabiex tagħmel distinzjoni bejn raxx ikkawżat minn dawn il- prodotti u reazzjonijiet ta` sensittività eċċessiva relatati ma` abacavir.
• Management after an interruption of Kivexa therapy
• Maniġġar wara interruzzjoni fit- terapija b’ Kivexa
If therapy with Kivexa has been discontinued for any reason and restarting therapy is under consideration, the reason for discontinuation must be established to assess whether the patient had any symptoms of a hypersensitivity reaction.
4 Jekk it- terapija b`Kivexa kienet twaqqfet minħabba xi raġuni jew oħra u hemm il- ħsieb li terġa ’ tinbeda t- terapija, għandu jiġi stabbilit għall- liema raġuni kienet twaqqfet it- terapija sabiex ikun rivelat jekk il- pazjent kellux xi sintomi ta ’ sensittività eċċessiva.
If a hypersensitivity reaction cannot be ruled out, Kivexa or any other medicinal product containing abacavir (Ziagen or Trizivir) must not be restarted.
Jekk wieħed ma jkunx ċert jekk kienx hemm xi reazzjoni ta` sensittività eċċessiva, Kivexa jew xi prodott mediċinali ieħor li fih abacavir (i. e.
Hypersensitivity reactions with rapid onset, including life-threatening reactions have occurred
Ziagen jew Trizivir) m`għandux jerġa ’ jibda jingħata.
4 after restarting abacavir in patients who had only one of the key symptoms of hypersensitivity (skin rash, fever, gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise) prior to stopping abacavir.
Attakki ta` sensittività eċċessiva qawwija u f’ daqqa, li jinkludu reazzjonijiet ta` perikli għall - ħajja dehru wara li reġa ’ ingħata abacavir f`pazjenti li kellhom biss wieħed mis- sintomi ewlenin ta` sensittività eċċessiva (sintomi ta ’ raxx tal- ġilda, deni, sintomi gastrointestinali, respiratorji jew konstituzzjonali bħal letarġija u telqa) qabel ma twaqqaf abacavir.
The most common isolated symptom of a hypersensitivity reaction was a skin rash.
L- aktar sintomu komuni iżolat ta` reazzjoni ta` sensittività eċċessiva kien raxx tal- ġilda.
Moreover, on very rare occasions hypersensitivity reactions have been reported in patients who have restarted therapy, and who had no preceding symptoms of a hypersensitivity reaction.
Barra minn hekk, okkażjonijiet rari ta` reazzjonijiet ta` sensittività eċċessiva dehru f`pazjenti li reġgħu bdew it- terapija, u li ma kellhom l- ebda sintomu qabel ta` reazzjoni ta` sensittività eċċessiva.
In both cases if a decision is made to restart abacavir this must be done in a setting where medical assistance is readily available.
Fiż- żewġ każijiet, jekk tittieħed deċiżjoni sabiex jerġa jibda jingħata abacavir, dan għandu jingħata biss fejn ikun hemm assistenza medika disponibbli mill- ewwel.
• Essential patient information
• Informazzjoni essenzjali għall- pazjent
Prescribers must ensure that patients are fully informed regarding the following information on the hypersensitivity reaction:
Min jikteb dan il- prodott għandu jkun fiż- żgur li l- pazjenti jingħataw it- tagħrif kollu meħtieġ fuq ir- reazzjonijiet ta` sensittività eċċessiva:
- Patients must be made aware of the possibility of a hypersensitivity reaction to abacavir that may
- Il- pazjent għandu jkun jaf bil- possibiltà ta` reazzjonijiet ta ’ sensittività eċċessiva għal abacavir li
result in a life-threatening reaction or death.
jistgħu jwasslu għal reazzjonijiet ta ’ periklu għall- ħajja kif ukoll għall- mewt.
- Patients developing signs or symptoms possibly linked with a hypersensitivity reaction MUST
- Pazjenti li jiżviluppaw sinjali jew sintomi li possibilment jistgħu ikunu relatati ma ’ reazzjonijiet
CONTACT their doctor IMMEDIATELY.
ta` sensittività eċċessiva GĦANDHOM JINFURMAW lit- tabib tagħhom MINNUFIH.
- Patients who are hypersensitive to abacavir should be reminded that they must never take Kivexa
- Pazjenti li għandhom sensittività eċċessiva għal abacavir għandhom jiġu mfakkra li
or any other medicinal product containing abacavir (Ziagen or Trizivir) again.
Ziagen jew Trizivir).
- In order to avoid restarting abacavir, patients who have experienced a hypersensitivity reaction
- Sabiex jiġi evitat li jerġa ’ jingħata abacavir, pazjenti li kellhom xi reazzjoni ta` sensittività
should dispose of their remaining Kivexa tablets in their possession in accordance with the local requirements, and ask their doctor or pharmacist for advice.
eċċessiva għandhom jiġu mitluba sabiex jirritornaw il- pilloli Kivexa li jkun għad baqalhom skond il- liġijiet lokali, u jitolbu parir tat- tabib jew l- ispiżjar.
- Patients who have stopped Kivexa for any reason, and particularly due to possible adverse
- Pazjenti li għal xi raġuni waqfu jieħdu Kivexa, u partikolarment jekk waqfu minħabba l -
reactions or illness, must be advised to contact their doctor before restarting.
possibiltà ta` reazzjonijiet avversi jew mard, għandhom jingħataw parir biex jinfurmaw lit - tabib qabel ma jerġgħu jibdewh.
- Patients should be advised of the importance of taking Kivexa regularly.
- Il- pazjenti għandhom ikunu infurmati dwar l- importanza li jieħdu Kivexa b’ mod regolari.
- Each patient should be reminded to read the Package Leaflet included in the Kivexa package.
- Għandha tinġibed l- attenzjoni ta ’ kull pazjent sabiex jaqra l- Fuljett ta` Tagħrif li jkun hemm
- They should be reminded of the importance of removing the Alert Card included in the package,
- Għandhom ikunu mfakkra fl- importanza li jneħħu l- Kartuna ta ’ twissija li jkun hemm fil -
and keeping it with them at all times.
pakkett u jżommuha dejjem fuqhom.
Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside analogues.
Aċidożi lattika: aċidożi lattika, ħafna drabi assoċjata ma ’ epatomegalija u stejatożi epatika, dehret bl - użu ta` analogi tan- nukleosidi.
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 bikrija (iperlaktejtimja sintomatika) jinkludu sintomi diġestivi beninji (dardir, rimettar kif ukoll uġigħ addominali), ħass ħażin mhux speċifiku, nuqqas ta ’ aptit, tnaqqis fil- piż, sintomi respiratorji (nifs mgħaġġel u/ jew fil- fond) jew sintomi newroloġiċi (li jinkludu indeboliment fil- movimenti).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.
Aċidożi lattika għandha rata għolja ta` mortalità u din tista tkun assoċjata ma ’ pankreatite, insuffiċjenza tal- fwied, jew tal- kliewi.
Lactic acidosis generally occurred after a few or several months of treatment.
5 Aċidożi lattika ġeneralment dehret wara ftit xhur tal- kura jew aktar.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Trattament b`analogi tan- nukleosidi għandu jitwaqqaf meta jkun hemm iperlaktejtimja sintomatika u aċidożi lattika/ metabolika, epatomegalija progressiva, jew meta l- livell ta ’ aminotransferase jitla ’ malajr.
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 tan- nuklejosajd lil kwalumkwe pazjent (b`mod speċjali lil nisa obeżi) b`epatomegalija, epatite jew xi fatturi oħra ta ’ riskju magħrufa għall- mard tal - fwied u stejatożi epatika (li jinkludi ċerti prodotti mediċinali u alkoħol).
Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Jista jkun hemm ukoll riskju speċjali f’ pazjenti li għandhom ukoll epatite C u li qed jingħataw kura b`alpha interferon u ribavirin.
5 Patients at increased risk should be followed closely.
Pazjenti li huma aktar f`riskju għandha tingħatalhom attenzjoni kbira.
Lipodystrophy: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Lipodistrofija: terapija kombinata antiretrovirali ġiet assoċjata mar- ridistribuzzjoni 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 għadhom mhux magħrufa.
Knowledge about the mechanism is incomplete.
Tagħrif fuq il- mekkaniżmu għadu mhux komplet.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Ġiet ipotesizzata konnessjoni bejn lipomatożi vixxerali u inibituri tal- protease (PIs) u lipoatrofija u inibituri tan- nukleoside reverse transcriptase (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 kien assoċjat ma ’ fatturi individwali bħal eta ’ avvanzata, kif ukoll ma ’ fatturi relatati mal- mediċina, bħal żmien itwal ta` kura b`antiretrovirali kif ukoll disturbi metaboliċi assoċjati mal- kura.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżaminazzjonijiet kliniċi għandhom jinkludu evalwazzjoni ta` sinjali fiżiċi li jindikaw ridistribuzzjoni tax- xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandu jiġi ikkunsidrat il- kejl tax- xaħam fid- demm u tal- glukożju fid- demm ta ’ meta l- pazjent ikun sajjem.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Problemi ta` xaħam fid - demm għandhom ikunu kkurati kif jixraq klinikament (ara sezzjoni 4. 8).
Pancreatitis: pancreatitis has been reported, but a causal relationship to lamivudine and abacavir is uncertain.
Każi ta ’ pankreatite ġew rappurtati, iżda għadu mhux magħruf jekk dan l- effett huwiex relatat mall- kura b`lamivudine u abacavir.
Clinical studies: the benefit of the combination of abacavir and lamivudine as a once daily regimen is mainly based on a study performed in combination with efavirenz, in antiretroviral-naïve adults patients (see section 5.1).
Studji kliniċi: il- benefiċċju ta ’ terapija kombinata ta ’ abacavir u lamivudine b’ kors ta ’ darba kuljum hi bażata prinċipalment fuq studju li sar f’ kombinazzjoni ma ’ efavirenz, f’ pazjenti adulti li qatt qabel ma kienu ħadu antiretrovirali (ara s- sezzjoni 5. 1)
Triple nucleoside therapy:
Terapija nukleosida tripla:
There have been reports of a high rate of virological failure, and of emergence of resistance at an early stage when abacavir and lamivudine were combined with tenofovir disoproxil fumarate as a once daily regimen.
Ġew rappurtati każi ta ’ rata għolja ta ’ indeboliment viroloġiku, u li nħolqot reżistenza fi stadju bikri meta abacavir u lamivudine ngħataw flimkien ma ’ tenofovir disoproxil fumarate b’ kors ta ’ darba kuljum.
Liver disease: 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.
Mard fil- fwied: jekk lamivudine jkun qed jingħata fl- istess ħin għall- kura ta ’ HIV u HBV, hemm aktar tagħrif disponibbli li għandu x’ jaqsam ma ’ l- użu ta ’ lamivudine fil- kura ta ’ l- infezzjoni epatite B fl - SPC ta ’ Zeffix.
The safety and efficacy of Kivexa has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ Kivexa ma ġewx stabbiliti f’ pazjenti b’ mard sinifikanti tal- fwied.
Kivexa is contraindicated in patients with severe hepatic impairment (see section 4.3).
Kivexa m’ għandux jingħata lil pazjenti b’ indeboliment serju tal- fwied (ara s- sezzjoni 4. 3).
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 b’ epatite kronika B jew C u li jkunu fuq terapija kombinata retrovirali jkunu qegħdin f’ riskju ogħla ta ’ effetti avversi fil- fwied li jistgħu ikunu serji u potenzjalment 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 tingħata ukoll terapija antivirali għall- epatite B jew C, jekk jogħġbok ara wkoll l- informazzjoni rilevanti dwar il - prodott għal dawn il- prodotti mediċinali.
If Kivexa is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see Zeffix SPC).
Jekk Kivexa titwaqqaf f’ pazjenti li jkunu infettati ukoll bil- virus ta ’ l- epatite B, hu rakkomandat monitoraġġ perjodikament kemm ta ’ testijiet dwar il- funzjoni tal- fwied, kif ukoll ta ’ markers ta ’ replikazzjoni ta ’ l- HBV, għax meta jitwaqqaf lamivudine l- epatite tista ’ terġa ’ toħroġ akutament (ara l- SPC ta ’ Zeffix).
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 minn disfunzjoni tal- fwied, inkluża l- epatite attiva kronika, tiżdidilhom il - frekwenza ta ’ anormalitajiet fil- funzjoni tal- fwied matul it- terapija antiretrovirali kombinata, u għandhom jiġu monitorjati skond il- prattika normali.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Jekk ikun jidher li l- mard fil- fwied ta ’ pazjenti
Mitochondrial dysfunction: nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Analogi tan- nukleosidi u tan- nekleotidi kemm in vitro kif ukoll in vivo wrew li jikkawżaw ħsara mitokondrjali varjabbli.
There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/ or post-natally to nucleoside analogues.
Kien hemm rapporti ta ’ każi ta 'funzjonament mitokondrjali ħażin fi trabi negattivi għall- HIV, li kienu esposti, in utero u/ jew wara t- twelid, għal analogi tan- nukleosidi.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
L - aktar effetti avversi rappurtati huma mard ematoloġiku (anemija, newtropenja) u disturbi ta 'metaboliżmu (iperlaktimja, iperlajpejżimja).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Ġew rappurtati xi disturbi newroloġiċi li ma tfaċċawx mill- ewwel (ipertonja, aċċessjoni, imġieba mhux normali).
Whether the neurological disorders are transient or permanent is currently unknown.
Mhuwiex 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
Kull tarbija li ġiet esposta in utero għal analogi tan- nukleosidi u tan- nukleotidi, anki meta tkun negattiva għall- HIV, għandha tibqa 'tiġi sorveljata klinikament jew f' laboratorju u għandha tkun investigata sew għal xi disfunzjoni mitokondrjali jekk jidhru xi sinjali jew sintomi rilevanti.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Dawn is - sejbiet m' għandhomx jaffettwaw ir- rakkomandazzjonijiet fis- seħħ dwar l- użu ta 'terapija antiretrovirali fil- każ ta' nisa tqal biex tiġi evitata t- trasmissjoni vertikali ta 'l- HIV.
Immune Reactivation Syndrome: 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 ’ Riattivazzjoni Immuni: f’ pazjenti nfettati bl- HIV b’ defiċjenza qawwija fl- immunita meta nbdiet tingħata t- terapija antiretrovirali kombinata (TARK), tista ’ tinħoloq reazzjoni infjammatorja għal patoġeni opportunistiċi asintomatiċi jew residwali u tikkawża kondizzjonijiet kliniċi serji jew tiggrava s- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn ġew osservati fl- ewwel ġimgħat jew xhur li fihom tkun bdiet it- TARK.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonjijiet mikobatterjali ġeneralizzati jew fokali, u pulmonite Pneumocystitis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu ta ’ infjammazzjoni għandu jiġu evalwat u għandu jinbeda trattament meta meħtieġ.
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 l- etjoloġija hi meqjusa li tkun ġejja minn ħafna fatturi (inklużi użu ta ’ sterojdi, konsum ta ’ alkoħol, immunosoppressjoni qawwija, indiċi ogħla ta ’ piż tal- ġisem), każi ta’ osteonekrożi ġew rappurtati partikularment f’ pazjenti bil- marda HIV avvanzata u/ jew esponiment fit- tul għal terapija antiretrovirali kombinata (TARK).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jingħataw parir li jkellmu tabib jekk iħossu uġigħ fil- ġogi, ebusija fil- ġogi jew diffikultà fil- movimenti tagħhom.
Kivexa contains the azo colouring agent sunset yellow, which may cause allergic reactions.
Kivexa fih s- sustanza azo li tagħti l- kulur, sunset yellow, li tista ’ tikkawża reazzjonijiet allerġiċi.
Opportunistic infections: patients should be advised that Kivexa or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Il- pazjenti għandhom ikunu avżati li Kivexa jew kull terapija antiretrovirali oħra ma jfejqux infezzjoni ta 'HIV u li dawn xorta jistgħu jiżviluppaw infezzjonijiet opportunistiċi u komplikazzjonijiet oħra ta' l- infezzjoni HIV.
Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Għalhekk il- pazjenti għandhom jibqgħu taħt osservazzjoni klinika stretta minn tobba b' esperjenza fil- kura ta 'dan il- mard assoċjat ma ’ l- HIV.
Transmission of HIV: patients should be advised that current antiretroviral therapy, including Kivexa, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Tixrid ta ’ HIV: pazjenti għandhom ikunu mwissija li t- terapija antiretrovirali tal- lum, inkluża Kivexa, ma ġietx pruvata li tneħħi r- riskju li tinxtered l- HIV permezz ta 'kuntatt sesswali jew kontaminazzjoni mid- demm.
Appropriate precautions should continue to be taken.
Il- prekawzjonijiet xierqa għandhom ikomplu jittieħdu.
Kivexa contains abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Kivexa.
Kivexa fih abacavir u lamivudine, għalhekk l’ interazzjonijiet kollha identifikati għal dawn huma rilevanti għal Kivexa.
Clinical studies have shown that there are no clinically significant interactions between abacavir and lamivudine.
Studji kliniċi urew li m’ hemmx interazzjonijiet kliniċi sinifikanti bejn abacavir u lamivudine.
Abacavir and lamivudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Abacavir u lamivudine m’ humiex metabolizzati b’ mod sinifikanti b’ enzimi cytochrome P450 (bħal CYP 3A4, CYP 2C9 jew CYP 2D6) u lanqas ma jimpedixxu jew jinduċu din is- sistema ta ’ enzimi.
Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.
Għalhekk mhux probabbli li jseħħu interazzjonijiet ma ’ inibituri tal- protease antiretrovirali ma’ non - nucleosides u prodotti mediċinali oħra metabolizzati bl- enzimi ewlenin ta ’ P450.
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 m’ għandhomx jitqiesu li jinkludu kollox imma jirrappreżentaw il- klassijiet ta ’ prodotti mediċinali kull fejn għandha tingħata attenzjoni.
Interactions relevant to abacavir
7 Interazzjonijiet rilevanti għal abacavir
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Inducers enżimatiċi qawwija bħall rifampicin, phenobarbital u phenytoin jistgħu mill- azzjoni tagħhom fuq UDP - glucuronyltransferases inaqqsu bi ftit il- konċentrazzjonijiet ta` abacavir fil- plażma.
The metabolism of abacavir is altered by concomitant consumption of ethanol resulting in an increase in AUC of abacavir of about 41%.
Il- metaboliżmu ta ’ abacavir jinibidel jekk jittieħed ma ’ l- etanol u dan jirriżulta f' żjieda fl- AUC ta ’ abacavir ta` madwar 41%.
These findings are not considered clinically significant.
Dawn ir- riżultati m`humiex kunsidrati klinikament sinifikanti.
Abacavir has no effect on the metabolism of ethanol.
Abacavir m`għandu l- ebda effett fuq il- metaboliżmu ta` l- etanol.
Retinoid compounds are eliminated via alcohol dehydrogenase.
Is- sustanzi retinojdi jiġu eliminati permezz ta ’ l- alkoħol dehydrogenase.
Interaction with abacavir is possible but has not been studied.
Interazzjoni ma ’ abacavir hija possibbli iżda ma ġietx studjata.
In a pharmacokinetic study, coadministration of 600 mg abacavir twice daily with methadone showed
Waqt studji farmakokinetiċi, meta 600 mg ta` abacavir jingħataw darbtejn kuljum flimkien ma 'methadone kien hemm tnaqqis ta ’ 35% fis- Cmax ta ’ abacavir u t- tmax żdiedet b' siegħa, iżda l`AUC ma nbidilx.
The changes in abacavir pharmacokinetics are not considered clinically relevant.
Il- bidliet farmakokinetiċi ta ’ abacavir mhumiex kunsidrati klinikament rilevanti.
In this study, abacavir increased the mean methadone systemic clearance by 22%.
F`dan l - istudju abacavir żied il- medja tat- tneħħija ta` methadone mis- sistema bi 22%.
The induction of metabolizing enzymes cannot therefore be excluded.
L- induzzjoni ta ’ enżimi li jimmetabolizzaw ma tistax għaldaqstant tiġi eskluża.
Patients being treated with methadone and abacavir should be monitored for evidence of withdrawal symptoms indicating under dosing, as occasionally methadone re-titration may be required.
Pazjenti li jkunu qed jingħataw kura b`methadone u abacavir għandhom jiġu eżaminati għal sintomi ta ’ twaqqif mill- kura li jindikaw dożi baxxi, minħabba li kultant jista jkun meħtieġ li terġa tiġi kkalkulata d- doża ta ’ methadone meħtieġa.
Interactions relevant to lamivudine
Interazzjonijiet rilevanti għal lamivudine
The likelihood of metabolic interactions with lamivudine is low due to limited metabolism and plasma protein binding, and almost complete renal clearance.
Hemm probabbilta` żgħira ta ’ interazzjonijiet metaboliċi ma ’ lamivudine minħabba metaboliżmu limitat u t- twaħħil ma ’ proteini tal- plażma, u kważi tneħħija kompleta mill- kliewi.
The possibility of interactions with other medicinal products administered concurrently with Kivexa should be considered, particularly when the main route of elimination is active renal secretion, especially via the cationic transport system e. g. trimethoprim.
Il- possibilta` ta ’ interazzjonijiet ma ’ prodotti mediċinali oħra mogħtija fl- istess ħin ma ’ Kivexa għandha tiġi kkunsidrata, b’ mod partikolari meta r- rotta ta ’ l- eliminazzjoni hija tnixxija attiva mill- kliewi, speċjalment mis- sistema ta ’ trasport ketajonika e. g. trimethoprim.
Other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Prodotti mediċinali oħra (e. g ranitidine, cimetidine) titneħħa biss parti minnhom b’ dan il- mekkaniżmu u deher li ma jikkawżawx interazzjoni ma ’ lamivudine.
The nucleoside analogues (e. g. zidovudine and didanosine) are not metabolised by this mechanism and are unlikely to interact with lamivudine.
L- analogi tan- nukleosidi (e. g. zinovudine u didanosine) ma jiġux metabolizzati b’ dan il- mekkaniżmu u aktarx ma jkollhomx interazzjoni ma ’ lamivudine.
Administration of trimethoprim/ sulfamethoxazole 160 mg/ 800 mg results in a 40% increase in lamivudine exposure, because of the trimethoprim component.
L- għoti ta ’ trimethoprim/ sulfamethoxazole 160 mg/ 800 mg jirriżulta f’ żjieda ta ’ 40% fl- esponiment ta ’ lamivudine, minħabba l- komponent trimethoprim.
However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary (see section 4.2).
Madankollu, sakemm il- pazjent ma ’ jkollux indeboliment tal- kliewi, ebda aġġustament fid- dożaġġ ma hu meħtieġ (ara sezzjoni 4. 2).
The pharmacokinetics of trimethoprim or sulfamethoxazole are not affected.
Ma jkun hemm ebda effett fuq il- farmakokinetiċi ta ’ trimethoprim jew sulfamethoxazole.
When concomitant administration with co- trimoxazole is warranted, patients should be monitored clinically.
Meta jkun hemm ġustifikazzjoni għall- għoti fl- istess ħin ta ’ co- trimoxazole, il- pazjenti għandhom ikunu monitorjati klinikament.
Co-administration of Kivexa with high doses of co-trimoxazole for the treatment of Pneumocystis carinii pneumonia (PCP) and toxoplasmosis should be avoided.
L- għoti ta ’ Kivexa flimkien ma ’ dożi għolja ta ’ co- trimoxazole għal trattament ta ’ pulmonite Pneumocystis carinii (PCP) u toxoplasmożi għandhom jiġu evitati.
Co-administration of lamivudine with intravenous ganciclovir or foscarnet is not recommended until further information is available.
L- għoti ta ’ lamivudine ma ’ ganciclovir jew foscarnet fil- vini mhuwiex rakkomandat sakemm ma ’ jkunx hawn aktar informazzjoni.
Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently.
Lamivudine jista ’ jimpedixxi il- phosphorylation ta ’ zalcitabine fiċ- ċelloli meta ż- żewġ prodotti mediċinali jingħataw flimkien.
Kivexa is therefore not recommended to be used in combination with zalcitabine.
Kivexa għalhekk mhux rakkomandat għal użu flimkien ma ’ zalcitabine.
Kivexa is not recommended during pregnancy.
Kivexa mhux rakkomandat waqt it- tqala.
The safety of abacavir and lamivudine in human pregnancy has not been established.
Għadu ma ġiex stabbilit jekk abacavir u lamivudine jistgħux ikunu ta ’ ħsara għall- bniedem meta jittieħed waqt it- tqala.
Studies with abacavir and lamivudine in animals have shown reproductive toxicity (see section 5.3).
Studji dwar abacavir u lamivudine f’ annimali wrew tossiċita ’ fis- sistema riproduttiva (ara s- sezzjoni 5. 3).
It is recommended that HIV-infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Hu rakkomandat li nisa nfettati bl- HIV ma jreddgħux lit- trabi tagħhom taħt kwalunkwe ċirkostanza biex ma jgħaddulhomx l- HIV.
Lamivudine is excreted in human milk at similar concentrations to those found in serum.
Lamivudine joħroġ fil- ħalib tas- sider fl- istess konċentrazzjonijiet bħal dawk li nstabu fis- serum.
It is expected that abacavir will also be secreted into human milk, although this has not been confirmed.
Hu mistenni li abacavir ukoll joħroġ fil- ħalib tas- sider, għalkemm dan għadu ma ġiex ikkonfermat.
It is therefore recommended that mothers do not breast-feed their babies while receiving treatment with Kivexa.
Għalhekk hu rakkomandat li l- ommijiet kollha ma ’ jreddgħux lit- trabi tagħhom
No studies on the effects on ability to drive and use machines have been performed.
8 waqt li jkunu qed jieħdu Kivexa.
4.8 Undesirable effects
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
For many of these adverse reactions it is
L- istatus kliniku tal - pazjent u l- effetti avversi ta ’ Kivexa fil- passat għandhom ikunu kkunsidrati meta titqies il- kapaċita` għal sewqan jew tħaddim ta ’ makkinarju.
8 unclear whether they are related to the active substance, the wide range of other medicinal products used in the management of HIV infection, or whether they are a result of the underlying disease process.
4. 8 Effetti mhux mixtieqa
Abacavir hypersensitivity (see also section 4.4)
Sensittività eċċessiva għall- Abacavir( ara wkoll sezzjoni 4. 4):
In clinical studies, approximately 5% of subjects receiving abacavir developed a hypersensitivity reaction.
Minn studji kliniċi li saru, nstab li bejn wieħed u ieħor 5% ta ’ l- individwi li jirċievu abacavir ikollhom reazzjoni ta` sensittività eċċessiva.
In clinical studies with abacavir 600 mg once daily the reported rate of hypersensitivity remained within the range recorded for abacavir 300 mg twice daily.
Fi studji kliniċi, fejn ingħataw 600 mg abacavir kuljum ir- rata rappurtata ta ’ sensittivita eċċessiva baqgħet fl- iskala rreġistrata għal 300 mg abacavir darbtejn kuljum.
Some of these hypersensitivity reactions were life-threatening and resulted in fatal outcome despite taking precautions.
Xi wħud minn dawn ir- reazzjonijiet ta ’ sensittivita eċċessiva kienu ta` periklu għall- ħajja u kienu fatali minkejja li kienu ttieħdu l- prekawzjonijiet.
This reaction is characterised by the appearance of symptoms indicating multi- organ/ body-system involvement.
Din ir- reazzjoni tingħaraf mid- dehra ta ’ sintomi li jindikaw involviment ta ’ ħafna organi/ sistemi tal- ġisem.
Almost all patients developing hypersensitivity reactions will have fever and/ or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Kważi l- pazjenti kollha li jkollhom reazzjonijiet ta` sensittività eċċessiva jkollhom deni u/ jew raxx (normalment makulopapulari jew bl- urtikarja) bħala parti mis- sindromu, madanakollu ġieli dehru reazzjonijiet mingħajr raxx jew deni.
The signs and symptoms of this hypersensitivity reaction are listed below.
Is- sinjali u s- sintomi ta` dawn ir- reazzjonijiet ta` sensittività eċċessiva huma mniżżlin hawn taħt.
These have been identified either from clinical studies or post marketing surveillance.
Dawn ġew identifikati minn studji kliniċi jew minn stħarriġ li sar wara li l- prodott tpoġġa fuq is - suq.
Those reported in at least 10% of patients with a hypersensitivity reaction are in bold text.
Dawk li ġew rappurtati minn ta`l- anqas f ’ 10% tal- pazjenti b`reazzjoni ta` sensittività eċċessiva huma miktubin b’ linka aktar skura.
Skin Rash (usually maculopapular or urticarial)
Ġilda Raxx (normalment makulopapulari jew ta ’ urtikarja)
Gastrointestinal tract
Sistema gastro- intestinali
Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Dardir, rimettar, dijarrea, uġigħ addominali, ulċera fil- ħalq
Respiratory tract
Sistema respiratorja
Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Dispneja, sogħla, uġigħ tal- griżmejn, sindromu ta ’ tbatija respiratorja fl- adulti, insuffiċjenza respiratorja
Miscellaneous
Oħrajn
Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Deni, letarġija, ħass ħażin, edima, limfadenopatija, pressjoni baxxa, konġuntivite, anafilassi
Neurological/ Psychiatry
Newroloġika/ Psikjatrija
Headache, paraesthesia
Uġigħ ta` ras, parasteżija
Haematological
Ematoloġiċi
Lymphopenia
Limfopenja
Liver/ pancreas
Fwied/ frixa
Elevated liver function tests, hepatitis, hepatic failure
Riżultati għoljin tat- testijiet ghall- funzjoni tal- fwied, epatite, indeboliment tal- fwied
Musculoskeletal
Muskolo- skeletriku
Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Mijalġja, rarament majoliżi, artralġja, livelli elevati ta ’ krejatinina fosfokajnejż
Urology
9 Uroloġija
Elevated creatinine, renal failure
Livelli għoljin tal- kreatinina, indeboliment tal- kliewi
Some patients with hypersensitivity reactions were initially thought to have gastroenteritis, respiratory disease (pneumonia, bronchitis, pharyngitis) or a flu-like illness.
F’ xi wħud mill- pazjenti b`reazzjonijiet ta` sensittività eċċessiva għall- ewwel kien hemm il- ħsieb li kellhom gastroenterite, mard respiratorju (pulmonite, bronkite, farinġite) jew mard simili li jixbaħ l- influwenza.
This delay in diagnosis of hypersensitivity has resulted in abacavir being continued or re-introduced, leading to more severe hypersensitivity reactions or death.
Id- dewmien fid- dijanjożi ta` sensittività eċċessiva fisser li abacavir kellu jitkompla jew jerġa ’ jingħata u dan wassal għal aktar reazzjonijiet ta ’ sensittivita eċċessiva u anke għal imwiet.
Therefore, the diagnosis of hypersensitivity reaction should be carefully considered for patients presenting with symptoms of these diseases.
Għalhekk, id- dijanjożi ta` sensittività eċċessiva għandha ssir bir- reqqa f`pazjenti li għandhom xi sintomi ta` dan il- mard.
Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Is- sintomi ġeneralment ħargu fl- ewwel sitt ġimgħat (medja tal- ħin biex jibdew 11- il ġurnata) mill - bidu tal- kura b`abacavir, għalkemm dawn ir- reazzjonijiet jistgħu joħorġu f`kull żmien matul it - terapija.
Close medical supervision is necessary during the first two months, with consultations every two weeks.
Il- pazjenti għandhom jingħataw attenzjoni kbira, b`mod speċjali matul l- ewwel xahrejn, b’ konsulti kull ġimgħatejn.
It is likely that intermittent therapy may increase the risk of developing sensitisation and therefore occurrence of clinically significant hypersensitivity reactions.
X’ aktarx li t- terapija ta ’ kultant iżżid ir- riskju ta ’ żvilupp ta ’ sensittivita u għalhekk jiżdied ir - riskju ta ’ reazzjonijiet sinifikanti ta ’ sensittivita eċċessiva.
Consequently, patients should be
Għaldaqstant, pazjenti għandhom jiġu mwissija dwar l- importanza li jieħdu Kivexa regolarment.
Restarting abacavir following a hypersensitivity reaction results in a prompt return of symptoms within hours.
Meta Kivexa jerġa ’ jibda jingħata wara reazzjonijiet ta` sensittività eċċessiva, l- istess reazzjonijiet jerġgħu joħorġu fi ftit sigħat.