qanastek/EMEA-V3 huggingface dataset:
4 symptoms of a hypersensitivity reaction.
4 Tkun meħtieġa attenzjoni speċjali għal dawk il- pazjenti li jibdew kura f' daqqa b’ Trizivir u prodotti mediċinali oħra magħrufa li joħolqu tossiċita 'fil- ġilda (bħal non- nucleoside reverse transriptase inhibitors – NNRTIs).
If a hypersensitivity reaction cannot be ruled out, Trizivir or any other medicinal product containing abacavir (i. e.
Dan għaliex sa llum kien diffiċli tiddistingwi bejn raxx kawżat minn dawn il - prodotti u reazzjonijiet ta 'sensittivita' eċċessiva relatati ma 'abacavir.
Kivexa, Ziagen) must not be restarted.
• Maniġġar wara l- interruzzjoni tat- terapija b’ Trizivir
The most common isolated symptom of a hypersensitivity reaction was a skin rash.
Jekk it- terapija b’ Trizivir tkun twaqqfet għal kwalunkwe raġuni u tkun qed tiġi kkunsidrata li terġa 'tinbeda t- terapija mill- ġdid, trid tiġi stabbilita r- raġuni l- għala twaqqfet biex jiġi analizzat jekk il - pazjent kellux xi sintomi ta' reazzjoni ta 'sensittivita' eċċessiva.
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.
Jekk reazzjoni ta 'sensittivita' eċċessiva ma tkunx tista 'tiġi eliminata, Trizivir jew xi prodott mediċinali ieħor li jkun fih abacavir (i. e.
In both cases if a decision is made to restart Trizivir this must be done in a setting where medical assistance is readily available.
Kixeva, Ziagen) m' għandux jerġa 'jibda jingħata.
• Essential patient information
• Tagħrif essenzjali għall- pazjent
Prescribers must ensure that patients are fully informed regarding the following information on the hypersensitivity reaction:
Dawk li jiktbu l- mediċina għandhom jiżguraw li l- pazjenti jkollhom informazzjoni tajba dwar ir - reazzjonijiet li ġejjin ta 'sensittivita' eċċessiva:
- Patients must be made aware of the possibility of a hypersensitivity reaction to abacavir
- Il- pazjenti għandhom ikunu avżati bil- possibilta 'ta' reazzjoni ta 'sensittivita' eċċessiva għal
that may result in a life-threatening reaction or death.
abacavir li tista 'tkun ta' periklu għall- ħajja jew li twassal għall- mewt.
- Patients developing signs or symptoms possibly linked with a hypersensitivity reaction
- Pazjenti li jiżviluppaw sinjali jew sintomi marbuta ma 'xi reazzjoni ta' sensittivita 'eċċessiva
MUST CONTACT their doctor IMMEDIATELY.
GĦANDHOM MINNUFIH IKELLMU lit- tabib tagħhom.
- Patients who are hypersensitive to abacavir should be reminded that they must never
- Pazjenti li jbatu b' sensittivita 'eċċessiva għal abacavir għandhom jiġu mfakkra li qatt iżjed
take Trizivir or any other medicinal product containing abacavir (i. e.
m' għandhom jerġgħu jieħdu Trizivir jew xi prodott mediċinali ieħor li jkun fih abacavir (i. e.
Kivexa, Ziagen) again.
Kixeva, Ziagen).
- In order to avoid restarting Trizivir, patients who have experienced a hypersensitivity reaction
- Biex jevitaw li jerġgħu jibdew jieħdu Trizivir, pazjenti b' esperjenza ta 'xi reazzjoni ta' sensittivita '
should dispose of their remaining Trizivir tablets in their possession in accordance with the local requirements, and ask their doctor or pharmacist for advice.
eċċessiva għandhom jarmu l- pilloli ta ’ Trizivir li jkun baqgħalhom skond il- ħtiġijiet tal- lokal, u jitolbu l- parir tat- tabib jew spiżjar tagħhom.
- Patients who have stopped Trizivir for any reason, and particularly due to possible adverse
- Pazjenti li għal xi raġuni jkunu waqqfu Trizivir, u partikolarment għall- possibilta 'ta' xi reazzjoni ħ
- reactions or illness, must be advised to contact their doctor before restarting.
aversa jew disturbi iridu jiġu mwissija biex ikellmu lit- tabib qabel jerġgħu jibdew jieħdu l - mediċina.
Patients should be advised of the importance of taking Trizivir regularly.
- Pazjenti għandhom jiġu avżati kemm hu importanti li Trizivir jittieħed regolarment.
- Each patient should be reminded to read the Package Leaflet included in the Trizivir pack.
- Kull pazjent għandu jiġi mfakkar li jrid jaqra l- Fuljett ta 'Tagħrif li jkun hemm fil- kartuna ta ’
They should be reminded of the importance of removing the Alert Card included in the pack, and keeping it with them at all times.
Għandu jiġi mfakkar biex ineħħi l- karta ta ’ twissija (Alert Card) minn ġol- pakkett u biex iżommha fuqu l- ħin kollu.
Lactic acidosis: lactic acidosis, usually associated with hepatomegaly and hepatic steatosis, has been reported with the use of nucleoside analogues.
Aċidożi lattika: aċidożi lattika, normalment assoċjata ma 'epatomegalija u steatosi tal- fwied, ġiet rappurtata ma' użu ta 'analogi 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 tal- bidu (hyperlactatemia sintomatika) jistgħu jkunu sintomi ta 'diġestjoni (dardir, rimettar u uġigħ ta' żaqq), ma tħossokx f' siktek, nuqqas ta 'aptit, nuqqas fil- piż, sintomi respiratorji (nifs mgħaġġel u qawwi) jew sintomi newroloġiċi (inkluż mutur nevralġiku għajjien).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.
Aċidożi lattika tikkawża mortalita 'għolja u hi assoċjata ma' pankreatite, kollass tal- fwied, jew kollass tal- kliewi.
Lactic acidosis generally occurred after a few or several months of treatment.
L- aċidożi lattika ġeneralment tfaċċat wara xi ftit xhur jew iżjed ta 'kura.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
5 Kura b’ nukleosidi analogi għandha titwaqqaf meta jkun hemm bidu ta 'hyperlactatemia u aċidożi metabolika/ lattika, epatomegalija progressiva, jew għoli f' salt fil- livelli ta' 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
Għandha tingħata attenzjoni meta pazjent jingħata nukleosidi analogi (partikolarment lil nisa ħoxnin) li jbatu bl- epatomegalija, epatite jew fatturi oħra ta 'riskju magħruf għal disturbi tal- fwied u steatożi tal- fwied (inklużi ċerti 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 li qed jiġu kkurati b’ alpha interferon u ribavirin huma ta 'riskju speċjali.
Patients at increased risk should be followed closely.
Pazjenti li jkunu f' riskju għoli għandhom ikunu monitorjati tajjeb.
Mitochondrial dysfunction: nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Kemm in vivo kif ukoll in vitro deher li l- analogi tan- nukleosidi u tan - nukleotidi jikkaġunaw gradi varjabbli ta ’ ħsara fil- mitokondrija.
The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
L- effetti avversi l- aktar komuni li kienu rrapurtati jinkludu disturbi ematoloġiċi (anemija, newtropenja) u disturbi metaboliċi (iperlaktimja, iperlipejżemja).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Xi disturbi newroloġiku li deher iktar tard ġie rrapurtat (ipertonja, aċċessjoni, imġieba mhux normali).
Whether the neurological disorders are transient or permanent is currently unknown.
Bħalissa għadu mhux mgħaruf jekk dan il- disturbi newroloġiku jgħaddix maż- żmien jew huwiex 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 esposta fl- utru għall- analogi tan- nukleosidi u tan - nukleotidi, anke trabi li huma negattivi għall- HIV, għandhom jiġu segwiti klinikament u f’ testijiet tal - laboratorju u jridu jiġu investigati kompletament għall- possibilita ’ ta ’ disfunzjoni tal- mitokondrija f’ każ ta ’ sinjali jew sintomi relevanti.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Dan it- tagħrif m’ għandux jafettwa r- rakkomandazzjonijiet kurrenti għall- użu tat- terapija antiretrovirali f’ nisa tqal għall- prevenzjoni tat- transmissjoni vertikali ta ’ l- HIV.
Lipodystrophy: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
It- terapija antiretrovirali kombinata ġiet assoċjata ma 'tqassim mill- ġdid tax- xaħam fil - ġisem (lipodistrofija) f' pazjenti bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fit- tul ta 'dawn l- affarijiet għad mhumiex magħrufa.
Knowledge about the mechanism is incomplete.
Tagħrif dwar il- mekkaniżmu għadu mhux sħiħ.
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.
Ġiet ipotizzata konnessjoni bejn lipomatożi tal- vixxri u inibituri protease (PI) u lipoatrofija u nucleoside reverse transcriptase inhibitors (NRTIs) Riskju ogħla ta 'lipodistrofija ġie assoċjat ma' fatturi individwali bħal eta 'avanzata, u ma' fatturi relatati ma 'drogi bħal kura antiretrovirali aktar fit- tul u disturbi metaboliċi assoċjati magħha.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi valutazzjoni għal sinjali fiżiċi ta 'tqassim mill- ġdid ta' xaħam fil- ġisem.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandha tingħata konsiderazzjoni għall- kejl ta 'lipidi fis- serum waqt li qed issum (fasting serum lipids) u glukożju fid- demm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Disturbi tal- lipidi għandhom jiġu maniġġati kif xieraq klinikament (ara sezzjoni 4. 8).
Haematological adverse reactions: anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
Reazzjonijiet avversi ematoloġiċi: anemija, newtropenja u lewkopenja (normalment sekondarji għan - newtropenja) jistgħu ikunu mistennija li jseħħu f' pazjenti li qed jieħdu zidovudine.
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 spissi f' dożaġġi ogħla ta 'zidovudine (1200- 1500 mg/ kuljum) u f' pazjenti b' riżerva batuta ta' mudullun ta 'l- għadam qabel il- kura, partikolarment b' disturbi avanzat ta' HIV.
Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Trizivir.
Paramemetri ematoloġiċi għandhom għalhekk ikunu monitorjati sew (ara sezzjoni 4. 3) f' pazjenti fuq Trizivir.
These haematological effects are not usually observed before four to six week’ s therapy.
Dawn l- effetti ematoloġiċi normalment ma jidhrux qabel terapija ta 'erba' jew sitt ġimgħat.
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.
Dwar pazjenti bil- marda ta 'l- HIV sintomatika avanzata, hu ġeneralment rakkomandat li testijiet tad- demm jitwettqu għall- inqas kull ġimgħatejn għall- ewwel tlett xhur ta' terapija u għall- inqas darba fix- xahar wara.
In patients with early HIV disease haematological adverse reactions are infrequent.
F' pazjenti fil- bidu tal- marda HIV reazzjonijiet avversi ematoloġiċi mhumiex ta 'spiss.
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 - kondizzjoni ġenerali tal- pazjent, testijiet tad- demm jistgħu ma jsirux daqshekk ta 'spiss, per eżempju darba kull xahar sa tlieta.
Additionally dosage adjustment of zidovudine may be required if severe anaemia or myelosuppression occurs during treatment with Trizivir, 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 hekk, jista 'jkun meħtieġ aġġustament fid- dożaġġ ta ’ zidovudine fil - każ ta' anemija jew myelosuppression waqt il- kura b’ Trizivir, jew f' pazjenti li diġa 'kellhom xi kondizzjoni mhux daqshekk tajba fil- mudullun ta' l- għadam eż. emoglobina < 9 g/ dl (5. 59 mmol/ l) jew għadd ta 'neutrophil < 1. 0 x 109/ l (ara sezzjoni 4. 2).
As dosage adjustment of Trizivir is not possible separate preparations of zidovudine, abacavir and lamivudine should be used.
Billi l- aġġustament fid- dożaġġ ta ’ Trizivir mhux possibbli preparazzjonijiet separati ta 'zidovudine, abacavir u lamivudine għandhom jiġu użati.
Physicians should refer to the individual prescribing information for these medicinal products.
It - tobba għandhom jirriferixxu għat- tagħrif preskritt individwalment għal dawn il- prodotti mediċinali.
Pancreatitis: cases of pancreatitis have occurred rarely in patients treated with abacavir, lamivudine and zidovudine.
Pankreatite: każi ta 'pankreatite seħħu rarament f' pazjenti fuq kura ta ’ abacavir, lamivudine u zidovudine.
However it is not clear whether these cases were due to treatment with these medicinal products or to the underlying HIV disease.
Madankollu mhuwiex ċar jekk dawn il- każi kienux dovuti għall- kura b' dawn il- prodotti mediċinali jew minħabba l- preżenza tal- marda HIV.
Treatment with Trizivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Il- kura b’ Trizivir għandha titwaqqaf minnufih jekk jitfaċċaw sinjali, sintomi jew anormalitajiet kliniċi li jindikaw pankreatite.
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.
6 Disturbi tal- fwied: jekk lamivudine ikun qed jintuża fl- istess ħin waqt il- kura ta 'HIV jew HBV, jeżisti tagħrif addizjonali dwar l- użu ta ’ lamivudine fil- kura ta' l- infezzjoni ta 'l- epatite B fl- SPC ta ’ Zeffix.
The safety and efficacy of Trizivir has not been established in patients with significant underlying liver disorders.
Is- sigurta 'u l- effikaċja ta ’ Trizivir ma ġietx stabbilita f' pazjenti b' disturbi tal- fwied sinifikanti.
Trizivir is contraindicated in patients with hepatic impairment (see section 4.3).
(ara sezzjoni 4. 3).
6 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 B jew C kronika fuq kura b' terapija antiretrovirali kombinata qegħdin f' riskju għoli ta 'effetti avversi serji u potenzjalment fatali fil- fwied.
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 ta 'terapija fl- istess ħin għall- epatite B jew C, jekk jogħġbok ara t- tagħrif dwar il- prodott għal dawn il- prodotti mediċinali.
If Trizivir 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 Trizivir jitwaqqaf f' pazjenti ko- infettati bil- virus ta 'l- epatite B, hu rakkomandat monitoraġġ perjodiku b' testijiet għall- funzjonament tal- fwied u markers tar- replikazzjoni ta' l- HBV, għax it - twaqqif ta ’ lamivudine jista ’ jirriżulta f’ aggravazjoni akuta ta ’ l- epatite (ara 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 minn qabel kienu jbatu minn funzjonament ħażin tal- fwied, inkluża l- epatite attiva kronika ikollhom żieda fil- frekwenza ta 'anormalitajiet fil- funzjonament tal- fwied waqt terapija antiretrovirali kombinata u għandhom jiġu monitorati 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 hemm sinjali f' dawn il - pazjenti li l- disturbi fil- fwied sejjer għall- agħar wieħed irid jara jekk it- trattament għandhiex titwaqqaf.
The comcomitant 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)
Children and adolescents: because insufficient data are available, the use of Trizivir in children or adolescents is not recommended.
Tfal u adolexxenti: billi m' hawnx data suffiċjenti, l- użu ta ’ Trizivir fit- tfal jew adolexxenti mhux rakkomandat.
In this patient population, hypersensitivity reactions are particularly difficult to identify.
F' din il- popolazzjoni ta 'pazjenti, reazzjonijiet ta' sensittivita 'eċċessiva huma partikolarment diffiċli biex tidentifikhom.
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 ’ Rijattivazzjoni Immunitarja: f’ pazjenti infettati bl- HIV, b’ defiċjenza immunitarja severa fiż- żmien li tkun inbdiet it- terapija antiretrovirali kombinata (CART), jista ’ jkun hemm reazzjoni infjammatorja għall- mikrobi opportunistiċi moħbija jew residwi li jwasslu għall- kundizzjonijiet kliniċi serji jew li sintomi jmorru għall- agħar.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomi ta ’ infammazzjoni għandhom ikunu evalwati u t- trattament jinbeda fejn hemm bżonn.
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, trażżin serju fl- immunita ’, body mass index għoli), każijiet ta ’ nekrożi fl- għadam instab li huwa partikolarment aktar komuni f’ pazjenti b’ HIVavvanzat u/ jew użu ta ’ terapija antiretrovirali kombinata (CART) fit- tul.
Opportunistic infections: patients should be advised that Trizivir or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Infezzjonijiet opportunistiċi: il- pazjenti għandhom ikunu avżati li Trizivir jew kull terapija antiretrovirali oħra ma jfejqux infezzjoni ta 'HIV u li dawn ikunu għadhom 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- disturbi assoċjat.
Miscellaneous: patients should be advised that current antiretroviral therapy, including Trizivir, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Oħrajn: pazjenti għandhom ikunu mwissija li t- terapija antiretrovirali tal- lum, inkluż Trizivir, ma ġiex pruvat li tneħħi r- riskju ta 'trasmissjoni ta' l- HIV lil ħaddieħor permezz ta 'kuntatt sesswali jew kontaminazzjoni mid- demm.
To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs (see section 5.1).
Sa llum għad ma kienx hawn data biżżejjed dwar l- effikaċja u s- sigurta 'ta' Trizivir meta jingħata fl - istess ħin mal- mediċini NNRTI jew PI (ara t- taqsima 5. 1).
The concomitant use of stavudine with zidovudine should be avoided (see section 4.5).
Għandu jiġi evitat l- użu flimkien ta ’ stavudine u zidovudine (ara sezzjoni 4. 5)
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
As Trizivir contains abacavir, lamivudine and zidovudine, any interactions that have been identified with these agents individually may occur with Trizivir.
Peress li Trizivir fih abacavir, lamivudine u zidovudine, kull fejn irriżulta li dawn l- aġenti individwalment ma qablux ma xulxin dan jista 'jiġri fil- każ ta ’ Trizivir.
Zidovudine is primarily eliminated by hepatic
Il- probabilta 'ta' nuqqas ta 'qbil metaboliku ma ’ lamivudine hi baxxa minħabba l- metaboliżmu limitat u t- tagħqid ta' proteina tal- plażma u t- tneħħija kważi totali mill- kliewi.
7 conjugation to an inactive glucuronidated metabolite.
Zidovudine jitneħħa l- aktar b' konjugazzjoni tal- fwied ma 'glucuronidated metabolite mhux attiv.
Medicinal products that are primarily eliminated by hepatic metabolism especially via glucuronidation may have the potential to inhibit metabolism of zidovudine.
Prodotti mediċinali li jitneħħew l- aktar b' metaboliżmu tal- fwied speċjalment permezz ta 'glucuronidation jista' jkollhom il- potenzjal li jinibixxu l- metaboliżmu ta ’ zidovudine.
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir are low.
Bażat fuq riżultati ta 'esperimenti in vitro u l- passaġġi metaboliċi ewlenin magħrufa, il- potenzjal għal interazzjonjiet medjati minn P450 ma' prodotti mediċinali oħra li jinvolvu abacavir huwa baxx.
Clinical studies have shown that there are no clinically significant interactions between abacavir, lamivudine and zidovudine.
Studji kliniċi wrew nuqqas sinifikanti ta 'qbil bejn abacavir, lamivudine u 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 m' għandhomx jitqiesu li jinkludu kollox biss jirrappreżentaw klassijiet ta 'prodotti mediċinali li għandhom jintużaw b' attenzjoni.
Interactions relevant to abacavir
Interazzjonjiet rilevanti għal abacavir:
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low.
Bażat fuq riżultati ta 'esperimenti in vitro u l- passaġġi metaboliċi ewlenin magħrufa, il- potenzjal għal interazzjonjiet medjati minn P450 ma' prodotti mediċinali oħra li jinvolvu abacavir huwa baxx.
P450 does not play a major role in the metabolism of abacavir, and abacavir does not inhibit metabolism mediated by CYP 3A4.
P450 m' għandux parti ewlenija fil- metaboliżmu ta 'abacavir, u abacavir ma jfixkilx il- metaboliżmu medjat b' CYP 3A4.
Abacavir has also been shown in vitro not to inhibit CYP 3A4, CYP 2C9 or CYP 2D6 enzymes at clinically relevant concentrations.
Abacavir in vitro wkoll wera li ma jfixkilx l- enżimi ta 'CYP 3A4, CYP 2C9 jew CYP 2D6 f' konċentrazjonijiet kliniċi relevanti.
Therefore, there is little potential for interactions with antiretroviral PIs and other medicinal products metabolised by major P450 enzymes.
Għalhekk, ftit hemm potenzjal għal nuqqas ta 'qbil bejn mediċini PI antiretrovirali u prodotti mediċinali oħra metabolizzati b' enzimi P450.
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Inducers enzimatiċi qawwijin bħal rifampicin, phenobarbital u phenytoin jistgħu bl- azzjoni tagħhom fuq UDP- glucuronyltransferases inaqqsu ftit il- konċentrazzjonijiet ta 'plażma ta' abacavir.
The metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%.
Il- metaboliżmu ta 'abacavir jinbidel meta jkun hemm ethanol miegħu u jirriżulta f' żieda ta' AUC ta 'abacavir ta' madwar 41%.
These findings are not considered clinically significant.
Dawn is- sejbiet mhumiex meqjusa sinifikanti klinikament.
Abacavir has no effect on the metabolism of ethanol.
Abacavir m' għandux effett fuq il- metaboliżmu ta 'l- etanol.
Retinoid compounds are eliminated via alcohol dehydrogenase.
Komposti ta 'retinoid jiġu eliminati ma ’ dehydrogenase ta' l- alkoħol.
Interaction with abacavir is possible but has not been studied.
Jista 'ma jkunx hemm qbil ma' abacavir biss dan ma ġiex studjat.
In a pharmacokinetic study, coadministration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir Cmax and a 1 hour delay in tmax, but the AUC was unchanged.
Fi studju farmakokinetiku, l- għoti fl- istess ħin ta '600 mg abacavir darbtejn kuljum ma ’ methadone irriżulta f' nuqqas ta' 35% fis - Cmax ta ’ abacavir u dewmien ta '1 siegħa fit- tmax, iżda l- AUC ma nbidilx.
The changes in abacavir pharmacokinetics are not considered clinically relevant.
Il- bidliet fil- farmakokinetiċi ta 'abacavir mhumiex meqjusa klinikament relevanti.
In this study, abacavir increased the mean methadone systemic clearance by 22%.
F' dan l- istudju, abacavir żied it- tneħħija sistemika medja ta ’ methadone bi 22%.
The induction of drug metabolizing enzymes cannot therefore be excluded.
L- induzzjoni ta 'enżimi li jimmetabolizzaw drogi ma tistax 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 fuq kura b’ methadone għandhom jiġu monitorjati għal sinjali ta 'xi sintomi tal- qtugħ tal- mediċina li jindikaw dożi żgħar wisq, għaliex kultant retitratazzjoni ta ’ methadone tkun meħtieġa.
Interactions relevant to lamivudine
Interazzonijiet rilevanti għal lamivudine:
The possibility of interactions with other medicinal products administered concurrently with Trizivir 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 li jkunu jingħataw flimkien ma ’ Trizivir għandha tkun ikkunsidrata, partikolarment meta r- rotta ewlenija ta' tneħħija tkun it- tnixxija attiva tal - kliewi speċjalment mis- sistema ta 'trasport ketajonika eż. trimetoprim.
Nucleoside analogues (e. g. zidovudine, didanosine and zalcitabine) and other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Nukleosidi analogi (eż. zidovudine, didanosine u zalcitabine) u prodotti mediċinali oħra (eż. ranitidine, cimetidine) jitneħħew parzjalment b' dan il- mekkaniżmu u rriżulta li jaqblu ma ’ lamivudine.
Administration of trimethoprim/ sulfamethoxazole 160 mg/ 800 mg results in a 40% increase in lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component does not interact.
L- għoti ta ’ trimethoprim/ sulfamethoxazole 160 mg/ 800 mg jirriżulta f' żieda ta '40% fl- esponiment ta ’ lamivudine, minħabba l- komponent trimetoprim; Il- komponent sulfamethoxazole ma ħoloqx nuqqas ta' qbil.
However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary (see section 4.2).
Madankollu, sakemm il- pazjent ma jkollux disturbi tal- kliewi, ma jkunx hemm bżonn ta 'bdil fid- dożaġġ ta ’ lamivudine (ara sezzjoni 4. 2).
Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Lamivudine m' għandu ebda effett fuq il- farmakokinetiċi ta ’ trimetoprim jew ta ’ sulfamethoxazole.
When concomitant administration with co-trimoxazole is warranted, patients should be monitored clinically.
Meta tinħass il- ħtieġa li dawn jingħataw flimkien, il- pazjenti
Co-administration of Trizivir with high doses of co-trimoxazole for the treatment of Pneumocystis carinii pneumonia (PCP) and toxoplasmosis should be avoided.
L- għoti ta ’ Trizivir flimkien ma 'dożi qawwija ta ’ co - trimoxazole għall- kura tal- pulmonite Pneumocystis carinii (PCP) u toxoplasmosis għandu jiġi evitat.
Co-administration of lamivudine with intravenous ganciclovir or foscarnet is not recommended until further information is available.
L- għoti ta ’ lamivudine flimkien ma 'ganciclovir jew foscarnet ġol- vini mhux rakkomandat sakemm jinkiseb aktar tagħrif
8 Lamivudine may inhibit the intracellular phosphorylation of zalcitabine when the two medicinal products are used concurrently.
Lamivudine jista 'ma jħallix phosphorylation intraċellulari ta ’ zalcitabine meta ż- żewġ prodotti mediċinali jintużaw flimkien.
Trizivir is therefore not recommended to be used in combination with zalcitabine.
Trizivir għalhekk mhux rakkomandat għall- użu flimkien ma ’ zalcitabine.
Lamivudine metabolism does not involve CYP 3A, making interactions with medicinal products metabolised by this system (e. g.
Il- metaboliżmu ta ’ lamivudine ma jinvolvix CYP3A, li għalhekk aktarx ma joħloqx nuqqas ta 'qbil ma' prodotti mediċinali metabolizzati b' din is- sistema (eż.
PIs and non-nucleosides) unlikely.
PIs u non- nukleosidi).
Interactions relevant to zidovudine
Interazzjonijiet rilevanti għal zidovudine
Limited data suggests that co-administration of zidovudine and rifampicin decreases the AUC of zidovudine by 48% ± 34%.
Data limitati jindikaw li l- għoti flimkien ta ’ zidovudine u rifampicin inaqqas l- AUC ta ’ zidovudine b' 48% ± 34%.
Limited data suggest that probenecid increases the mean half-life and area under the plasma concentration curve of zidovudine by decreasing glucuronidation.
Data limitati jindikaw li probecenid iżid il- ħin medju biex il- livell ta 'tneħħija ta ’ zidovudine jinżel bin- nofs u ż- żona taħt il- kurva ta' konċentrazzjoni ta ’ zidovudine billi jnaqqas il- glucuronidation.
Renal excretion of the glucuronide (and possibly zidovudine itself) is reduced in the presence of probenecid.
Tnixxija mill- kliewi ta ’ glucuronide (u possibilment ta ’ zidovudine stess) tonqos meta jkun preżenti probenecid.
Patients receiving both drugs should be closely monitored for haematological toxicity.
Pazjenti li qegħdin jirċievu iż- żewġ mediċini għandu jiġu osservati mill- qrib għal tossiċità ematoloġika.
Phenytoin blood levels have been reported to be low in some patients receiving zidovudine, while in one patient a high level was noted.
Livelli ta 'phenytoin fid- demm instab li kienu baxxi f' xi pazjenti li qed jingħataw zidovudine, waqt li pazjent wieħed instablu livell għoli.
These observations suggest that phenytoin concentrations should be carefully monitored in patients receiving Trizivir and phenytoin.
Dawn l- osservazzjonijiet jindikaw li konċentrazzjonijiet ta 'phenytoin għandhom jiġu monitorjati sew f' pazjenti li jkunu qed jieħdu Trizivir u phenytoin.
In a pharmacokinetic study co-administration of zidovudine and atovaquone tablets showed a decrease in zidovudine clearance after oral dosing leading to a 35% ± 23% increase in plasma zidovudine AUC.
Fi studju farmakokinetiku l- għoti fl- istess ħin ta 'pilloli ta ’ zidovudine u atovaquone wera nuqqas fit - tneħħija ta' zidovudine wara doża li ttieħdet mill- ħalq li rriżulta f' żieda ta 35% ± 23% fl- AUC ta 'zidovudine fil- plażma.
The mode of interaction is unknown and as higher concentrations of atovaquone can be achieved with atovaquone suspension it is possible that greater changes in the AUC values for zidovudine might be induced when atovaquone is administered as a suspension.
Mhuwiex magħruf il- mod ta ’ interazzjoni u billi konċentrazzjonijiet ta ’ atovaquone aktar għoljin jistgħu jintlaħqu bis- sospensjoni ta ’ atavaquone, huwa possibli li bdil akbar fl- AUC għal zidovudine jistgħu jkunu indotti meta atovaquone tingħata bħala sospensjoni.
Given the limited data available the clinical significance of this is unknown.
Skond id - data limitati eżistenti is- sinifikat kliniku ta 'dan mhux magħruf.
Valproic acid, fluconazole or methadone when co-administered with zidovudine have been shown to increase the AUC of zidovudine, with a corresponding decrease in its clearance.
Valproic acid, fluconazole jew methadone meta jittieħdu flimkien ma ’ zidovudine instab li jżidu l - AUC ta ’ zidovudine, bi tnaqqis korrispondenti fit- tneħħija tiegħu.
As only limited data are available the clinical significance of this is not known.
Peress li d- data eżistenti huma limitati is- sinifikat kliniku ta 'dan mhux magħruf.
Zidovudine and stavudine in combination are antagonistic in vitro, therefore, the concomitant use of stavudine with Trizivir should be avoided (see Section 4.4).
Zidovudine u stavudine huma antagonistiċi in vitro, għalhekk it- teħid ta ’ stavudine flimkien ma ’ Trizivir għandu jiġi evitat (ara Sezzjoni 4. 4).
Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Ġie irrapurtat li anemija marret għall- agħar minħabba ribavirin meta zidovudine kien parti mis- sistema ta ’ kura użat biex jittratta HIV għalkemm il- mekkaniżmu eżatt għadu mhux magħruf.
Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established.
Għandu jiġi kkunsidrat li jinbidel zidovudine f’ sistema ta ’ kura ART kombinata jekk din tkun digà stabbilita.
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e. g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine.
It- teħid fl- istess ħin, speċjalment f' terapija akuta, ta 'prodotti mediċinali potenzjalment nefrotossiċi, myelosuppressive (eż. pentamidine, dapsone, pyrimethamine, co- trimaxozole, amphotericin, flucytosine, interferon, vincristine, vinblastine u doxorubicin) jistgħu iżidu r- riskju ta' reazzjonijiet avversi għal zidovudine.
If concomitant therapy with Trizivir and any of these medicinal products is necessary then extra care should be taken in monitoring renal function and haematological parameters and, if required, the dosage of one or more agents should be reduced.
Jekk it- terapija f' daqqa b’ Trizivir ma 'xi wieħed minn dawn il- prodotti mediċinali tkun meħtieġa allura trid tingħata attenzjoni speċjali għall- monitoraġġ tal- funzjonament tal - fwied u l- parametri ematoloġiċi u, jekk hemm bżonn, id- dożaġġ ta' xi aġent jew aġenti għandu
9 Clarithromycin tablets reduce the absorption of zidovudine.
9 jitnaqqas.
This can be avoided by separating the administration of Trizivir and clarithromycin by at least two hours.
It- teħid ta 'Trizivir flimkien ma' dożi qawwija ta 'co- trimaxozole għall- kura tal- pulmonite Pneumocystis carinii (PCP) u toxoplasmosis għandu jiġi evitat.
Trizivir is not recommended during pregnancy.
Trizivir mhux rakkomandat waqt it- tqala.
There are no data on the use of Trizivir in pregnancy.
M' hawnx data fuq l- użu ta ’ Trizivir waqt it- tqala.
Placental transfer of lamivudine and zidovudine occurs in humans, and for abacavir has been confirmed in animals.
Trasferiment fil- plaċenta ta 'lamivudine u zidovudine jiġri fil- bniedem, u dan ġie anki konfermat dwar abacavir fl- annimali.
Studies with abacavir, lamivudine and zidovudine in animals have shown reproductive toxicity (see section 5.3).
Studji dwar abacavir, lamivudine u zidovudine fl- annimali wrew tossiċita 'riproduttiva (ara t- taqsima 5. 3).
As the active substances of Trizivir may inhibit DNA replication any use, especially during the first trimester, presents a potential risk to the foetus.
Peress li s- sustanzi attivi ta ’ Trivizir jistgħu jimpedixxu r- replikazzjoni ta 'DNA, kull użu, fl- ewwel perjodu ta' tliet xhur, joħloq riskju potenzjali għall- fetu.
Lactation
Treddigħ:
Both lamivudine and zidovudine are excreted in human milk at similar concentrations to those found in serum.
Kemm lamivudine u zidovudine joħorġu mal- ħalib tas- sider fil- bniedem f' konċentrazzjonijiet simili għal dawk li jinsabu fis- serum.
It is expected that abacavir will also be secreted into human milk, although this has not been confirmed.
Wieħed għandu jistenna li abacavir jinġemgħa wkoll fil- ħalib uman, għalkemm dan ma ġiex konfermat.
It is therefore recommended that mothers do not breast-feed their babies while receiving treatment with Trizivir.
Għalhekk hu rakkomandat li ommijiet m' għandhomx ireddgħu lit - trabi tagħom waqt li jkunu qed jieħdu Trizivir.
Additionally, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Barra dan, hu rakkomandat li nisa infettati bl- HIV m' għandhomx, taħt l- ebda cirkostanza ireddgħu it- trabi tagħhom biex ma jgħaddulhomx l- HIV.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila għas- sewqan u għat- tħaddim ta 'magni.
The clinical status of the patient and the adverse event profile of Trizivir should be borne in mind when considering the patient’ s ability to drive or operate machinery.
L- istat kliniku tal - pazjent u l- profil ta 'effetti avversi ta ’ Trizivir ta ’ minn iżomm f’ moħħu meta qed tiġi kkunsidrata l - ħila tal- pazjent biex isuq jew iħaddem makkinarju.
Overview
Deskrizzjoni qasira:
Adverse reactions have been reported with abacavir, lamivudine and zidovudine used separately or in combination for therapy of HIV disease.
Jeżistu rapporti ta 'reazzjonijiet avversi għal abacavir, lamivudine u zidovudine kemm meta ntużaw separatament u kemm flimkien fit- terapija għall- marda HIV.
Because Trizivir contains abacavir, lamivudine and zidovudine, the adverse reactions associated with these compounds may be expected.
Billi Trizivir fih abacavir, lamivudine u zidovudine, ir- reazzjonijiet avversi assoċjati ma 'dawn it- taħlitiet jista' wieħed jistennihom.
Hypersensitivity to abacavir (see also section 4.4):
Sensittivita 'eċċessiva għal' abacavir ’ (ara wkoll it- taqsima 4. 4):
In clinical studies, approximately 5% of subjects receiving abacavir developed a hypersensitivity reaction; some of these were life-threatening and resulted in fatal outcome despite taking precautions.
Fi studji kliniċi, madwar 4% ta 'suġġetti li kienu fuq abacavir żviluppaw reazzjoni ta' sensittivita 'eċċessiva; ftit minn dawn kienu ta' periklu għall- ħajja u spiċċaw f' imwiet minkejja l- prekawzjonijiet li ttieħdu.
This reaction is characterised by the appearance of symptoms indicating multi-organ/ body-system involvement.
Din ir- reazzjoni hi karatterizzata bid- dehra ta 'sintomi li jindikaw involviment tas- sistema ta' ħafna organi jew tal- ġisem kollu.
Almost all patients developing hypersensitivity reactions will have fever and/ or rash (usually maculopapular or urticarial) as part of the syndrome, however hypersensitivity reactions have occurred without rash or fever.
Kważi l- pazjenti kollha li jiżviluppaw reazzjonijiet ta 'sensittivita' eċċessiva jkollhom deni u/ jew raxx (normalment makulopapulari jew urtikarjali) bħala parti mis- sindromu, madankollu reazzjonijiet ta 'sensittivita' eċċessiva seħħew ukoll mingħajr raxx jew deni.
The signs and symptoms associated with hypersensitivity to abacavir are summarised in Table 1.
Is- sinjali u s- sintomi assoċjati ma 'sensittivita' eċċessiva għal abacavir jidhru fil- qosor fit- Tabella 1.
These have been identified either from clinical studies or post marketing surveillance.
10 Dawn ġew identifikati minn studji kliniċi jew wara li l- prodott tpoġġa fuq is- suq.
Some patients with hypersensitivity reactions were initially thought to have gastroenteritis, respiratory disease (pneumonia, bronchitis, pharyngitis) or a flu-like illness.
Xi pazjenti b' reazzjonijiet ta 'sensittivita' eċċessiva fil- bidu ħasbu li kellhom xi gastroenterite, xi disturbi respiratorju (pulmonite, bronkite farinġite) jew xi disturbi bħall- influwenza.
This delay in diagnosis of hypersensitivity has resulted in abacavir being continued or re-introduced, leading to more severe hypersensitivity reactions or death.
Dan id- dewmien qabel id- dijanjosi ta 'sensittivita' eċċessiva spiċċa biex kellhom ikomplu jew jibdew jieħdu abacavir, li wassal għal reazzjonijiet ta 'sensittivita' eċċessiva iżjed severi u anki wassal għall- mewt.
Therefore, the diagnosis of hypersensitivity reaction should be carefully considered for patients presenting with symptoms of these diseases.
Għalhekk, id - dijanjosi ta 'reazzjoni ta' sensittivita 'eċċessiva għandha tkun meqjusa sew f' pazjenti li juru sintomi ta' disturbi bħal dan.
10 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.
Ġeneralment is- sintomi dehru fl- ewwel sitt ġimgħat (mill- ħin medjan sa ma toħroġ il- marda 11- il jum) wara li nbdiet it- trattament b’ abacavir, għalkemm dawn ir- reazzjonijiet jistgħu jidhru f' kull ħin waqt it - terapija.
Close medical supervision is necessary during the first two months, with consultations every two weeks.
Sorveljanza medika stretta tkun meħtieġa fl- 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.
Aktarx li terapija mhux kontinwa tista 'żżid ir- riskju ta żvilupp ta' sensittizazzjoni u għalhekk tar - reazzjonijiet kliniċi ta 'sensittivita' eċċessiva sinifikanti.
Consequently, patients should be advised of the importance of taking Trizivir regularly.
Għalhekk, il- pazjenti għandhom ikunu mwissija dwar l- importanza li Trizivir jittieħed regolarment.
Restarting Trizivir, or any other medicinal product containing abacavir, following a hypersensitivity reaction would result in a prompt return of symptoms within hours.
It- teħid mill- ġdid ta ’ Trizivir, jew xi prodott mediċinali ieħor li jkun fih abacvir, wara xi reazzjoni ta 'sensittivita' eċċessiva jirriżulta li jerġgħu jitfaċċaw is- sintomi fi ftit siegħat.
This recurrence of the hypersensitivity reaction was usually more severe than on initial presentation and may include life- threatening hypotension and death.
Meta terġa 'titfaċċa s - sensittivita' eċċessiva ir- reazzjoni ġeneralment tkun aktar qawwija mill- ewwel darba u tista 'tikkawża pressjoni baxxa ħafna li tipperikola l- ħajja u tista anki twassal għall- mewt.
Kivexa, Ziagen).
Il- pazjenti li jiżviluppaw din ir- reazzjoni ta 'sensittivita' eċċessiva għandhom iwaqqfu Trizivir u m' għandhom qatt jerġgħu jingħataw Trizivir jew kull prodott mediċinali ieħor li jkun fih abacavir (i. e Kixeva, Ziagen).
To avoid a delay in diagnosis and minimise the risk of a life-threatening hypersensitivity reaction, Trizivir must be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory disease, flu-like illness, gastroenteritis or reactions to other medications).
Biex jiġi evitat dewmien tad- dijanjosi u jitnaqqas ir- riskju ta 'reazzjoni ta' sensittivita 'eċċessiva li tipperikola l- ħajja, Trizivir għandu jitwaqqaf permanentement meta s- sensittivita' eċċessiva ma tistax tiġi eliminata, anki fil- possibilta 'ta' dijanjosi oħra (disturbi respiratorju, disturbi qiesu influwenza, gastroenterite jew reazzjonijiet għal xi mediċini oħra).
Hypersensitivity reactions with rapid onset, including life-threatening reactions have occurred 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.
Reazzjonijiet ta 'sensittivita' eċċessiva li jiżviluppaw f' salt, inklużi reazzjonijiet ta 'periklu għall - ħajja seħħew malli pazjenti b' sintomu prinċipali wieħed biss ta' sensittivita 'eċċessiva (raxx tal - ġilda, deni, sintomi gastrointestinali, respiratorji u kostituzzjonali bħal letarġija u telqa) ikunu reġgħu bdew jieħdu abacavir wara li kienu waqqfuh qabel.
The most common isolated symptom of a hypersensitivity reaction was a skin rash.
L- aktar sintomu iżolat komuni ta 'reazjonijiet ta' sensittivita 'eċċessiva hu 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 dan f' każi rarissimi reazzjonijiet ta 'sensittivita' eċċessiva ġew rappurtati f' pazjenti li jkunu reġgħu bdew it- terapija, u li qabel qatt ma kellhom sintomi ta 'reazzjoni ta' sensittivita '.
In both cases if a decision is made to restart Trizivir this must be done in a setting where medical assistance is readily available.
Fiż- żewġ każi jekk tittieħed deċiżjoni biex jerġgħa jinbeda Trizivir dan għandu jsir fejn assistenza medika tkun qiegħda għal- lest.
Each patient must be warned about this hypersensitivity reaction to abacavir.
Kull pazjent għandu jiġi mwissi dwar ir- reazzjoni ta 'sensittivita' eċċessiva tiegħu għal abacavir.
Summary of signs and symptoms associated with hypersensitivity to abacavir (Signs and symptoms reported in at least 10% of patients with a hypersensitivity reaction to abacavir are in bold text).
Sommarju ta 'sinjali u sintomi assoċjati ma' sensittivita 'eċċessiva għal abacavir (Sinjali u sintomi rappurtati għall- inqas f' 10% ta' pazjenti b' reazzjoni ta 'sensittivita' eċċessiva għal abacavir qegħdin b' tipi grassi)
Nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
11 Sistema tal- ġisem Passaġġ gastrointestinali Newroloġika/ psikjatrija Ematoloġika Fwied/ frixa Muskuloskeletali Passaġġ respiratorju Ġilda Uroloġija Oħrajn
Myalgia, rarely myolysis, arthralgia, elevated creatine phosphokinase
Reazzjoni avversa Dardir, rimettar, dijareja, uġigħ ta 'żaqq, ulċeri tal- ħalq Uġigħ ta' ras, paraesteżija Limfopenja Testijiet tal- funzjonament tal- fwied elevat, epatite, kollass tal- fwied Myalgia, rarament myolysis, arthralgia.
Dyspnoea, sore throat, cough, adult respiratory distress syndrome, respiratory failure
Livell elevat ta ’ Qtugħ ta ’ nifs, ħruq fil- grieżem, sogħla, sindrome ta 'nifs Raxx (ġeneralment makulopapulari jew urtikarjali) Livell għoli ta' kreatinin, indeboliment tal- kliewi Deni, nagħas, ma 'tħossokx tajjeb, edema, limfadenopatija, pressjoni baxxa ħafna, konguntivite, anafilassi
Rash (usually maculopapular or urticarial)
Rapporti ta 'effetti mhux mixtieqa mis- sustanzi individwali
11 Undesirable effects reported with the individual substances The adverse reactions reported with abacavir, lamivudine and zidovudine are presented in Table 2.
Ir- reazzjonijiet avversi rrappurtati b’ abacavir, lamivudine u zidovudine jidhru fit- Tabella 2.
They are listed by body system, organ class and absolute frequency.
Huma elenkati skond is- sistema tal- ġisem, klassi ta ’ l- organi u l- frekwenza assoluta.
Frequencies are defined as very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1000), very rare (< 1/ 10,000).
Il- frekwenzi huma mfissra bħala komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10), mhux komuni (> 1/ 1, 000, < 1/ 100), rari (> 1/ 10, 000, < 1/ 1, 000) rari ħafna (< 1/ 10, 000).
Care must be taken to eliminate the possibility of a hypersensitivity reaction if any of these symptoms occur.
Trid tingħata attenzjoni biex tiġi eliminata l- possibilta 'ta' reazzjoni ta 'sensittivita' eċċessiva fil- każ li jitfaċċaw xi sintomi minn dawn.