natgillin/translations-raw huggingface dataset:
CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Kivexa if:
ODMAH SE JAVITE SVOM LIJEČNIKU koji će Vam savjetovati trebate li prestati uzimati lijek Kivexa ako: 1) dobijete osip po koži ILI
About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLAB*5701 gene developed a hypersensitivity reaction.
Reakcija preosjetljivosti razvila se u približno 3 do 4 na svakih 100 bolesnika koji su se liječili abakavirom u kliničkim ispitivanjima, a nisu imali gen HLA-B*5701.
ANTI-INFECTIVE PRODUCTS Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
ANTIINFEKTIVNI LIJEKOVI trimetoprim/sulfametoksazol (kotrimoksazol)/abakavir
RETINOIDS Retinoid compounds (e.g. isotretinoin)/Abacavir
spojevi retinoida (npr. isotretinoin) /abakavir
Elevated liver function tests, hepatitis, hepatic failure
Jetra/gušterača povišene razine jetrenih enzima, hepatitis, zatajenje jetre
Phenotypic susceptibility analyses of clinical isolates from antiretroviral-naïve patients with HIV-1 Group M non-B subtypes in three studies have each reported that all viruses were fully susceptible to both abacavir and lamivudine; one study of 104 isolates that included subtypes A and A1 (n=26), C (n=1), D (n=66), and the circulating recombinant forms (CRFs) AD (n=9), CD (n=1), and a complex inter-subtype recombinant_cpx (n=1), a second study of 18 isolates including subtype G (n=14) and CRF_AG (n=4) from Nigeria, and a third study of six isolates (n=4 CRF_AG, n=1 A and n=1 undetermined) from Abidjan (Côte d'Ivoire).
(n=26), C (n=1), D (n=66) i cirkulirajuće rekombinantne oblike (CRFa) AD (n=9), CD (n=1), i kompleksne rekombinantne_cpx između podtipova (n=1), drugo ispitivanje sa 18 izolata uključujući podtip G (n=14) i CRF_AG (n=4) iz Nigerije, i treće ispitivanje sa šest izolata (n=4 CRF_AG, n=1 A i n=1 neodređeno) iz Abidjana (Obala Bjelokosti).
Efficacy Outcome at Week 48 in CNA30021 by baseline HIV-1 RNA and CD4 Categories (ITTe TLOVR ART naïve subjects).
Ishod djelotvornosti u 48 tjednu u ispitivanju oznake CNA30021 prema početnim HIV-1 RNA i
Talk to your doctor if any of these apply to you before using Kivexa.
Obavijestite svog liječnika prije uzimanja lijeka Kivexa ako se bilo što od navedenog odnosi na Vas.
30 tablets in opaque white (PVC/PVDCAluminium/Paper) child-resistant blister packs Multipacks containing 90 (3 packs of 30) tablets in opaque white (PVC/PVDC-Aluminium/Paper) child-resistant blister packs.
Višestruko pakiranje sadrži 90 (3 pakiranja od 30) tableta u u neprozirnom bijelom (PVC/PVDCAl/papir) blister pakiranju sa sigurnosnom folijom za djecu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
Response by Baseline HIV-1 RNA <100,000 c/mL
Odgovor na osnovu HIV-1 RNA <100 000 c/mL
Very rare: lactic acidosis
Vrlo rijetko: laktacidoza
For the CNA109586 (ASSERT) and CNA30021 studies in treatment-naïve patients, genotype data was obtained for only a subset of patients at screening or at baseline, as well as for those patients who met virologic failure criteria.
1 Glavne IAS-USA mutacije na abakavir ili lamivudin i mutacije povezane s višestrukom-NRTI rezistencijom U ispitivanjima CNA109586 (ASSERT) i CNA30021 koja su provedene na neliječenim bolesnicima, genotipski podaci dobiveni su samo kod podskupine bolesnika pri probiru ili pri početku ispitivanja kao i za one bolesnike koji su udovoljavali kriterijima izostanka virološkog odgovora.
The symptoms related to HSR worsen with continued therapy and can be life-threatening.
Simptomi povezani s reakcijom preosjetljivosti pogoršavaju se s nastavkom terapije i mogu ugroziti život bolesnika.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)
Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Drugi znakovi i simptomi primijećeni kao dio reakcija preosjetljivosti na abakavir detaljno su opisani u dijelu 4.8
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Iz tih podataka o embriofetalnoj toksičnosti ne mogu se izvući zaključci o teratogenom potencijalu abakavira.
Phenytoin/Abacavir
fenitoin/abakavir
Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see section 5.2).
Ne preporučuje se primjena lijeka Kivexa u bolesnika s klirensom kreatinina < 50 ml/min jer se ne može provesti potrebna prilagodba doze (vidjeti dio 5.2).
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
- Triple nucleoside therapy: 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.
- Liječenje kombinacijom tri nukleozida: Pri kombiniranoj primjeni abakavira i lamivudina s tenofovir dizoproksilfumaratom jedanput na dan, zabilježena je visoka stopa izostanka virološkog odgovora te nastup rezistencije u ranoj fazi liječenja.
Kivexa is not recommended for use in patients with a creatinine clearance < 50 ml/min as necessary dose adjustment cannot be made (see section 4.2).
Ne preporučuje se primjena lijeka Kivexa u bolesnika s klirensom kreatinina < 50 ml/min jer se ne može provesti potrebna prilagodba doze (vidjeti dio 4.2).
NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets
NAZIV LIJEKA Kivexa 600 mg/300 mg filmom obložene tablete
There was also no clinically significant food effect observed between administration of FDC in the fasted or fed state.
Također nisu zapaženi klinički značajni učinci hrane na primjenu fiksne kombinacije natašte ili uz obrok.
: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Lamivudin se najvećim dijelom uklanja izlučivanjem putem bubrega u nepromijenjenom obliku.
Proportion of Patients in CAL30001 with <50 copies/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Udio bolesnika u ispitivanju CAL30001 s <50 kopija/mL u 48. tjednu prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either Kivexa once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
U ispitivanju CAL30001, 182 bolesnika koji pri prethodnom liječenju nisu imali virološki odgovor randomizirani su tako da su tijekom 48 tjedana dobivali ili lijek Kivexa jedanput na dan ili abakavir u dozi od 300 mg dvaput na dan uz lamivudin 300 mg jedanput na dan, u oba slučaja u kombinaciji s tenofovirom i nekim inhibitorom proteaze ili nekim nenukleozidnim inhibitorom reverzne transkriptaze.
The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Srednji omjer koncentracija lamivudina u likvoru i serumu 2-4 sata nakon peroralne primjene iznosi oko
These may affect up to 1 in 1000 people:
Rijetke nuspojave Mogu se pojaviti u manje od 1 na 1000 osoba:
• numbness, tingly feelings in the skin (pins and needles)
• utrnulost, osjećaj trnaca na koži (mravinjanje),
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipacks of 90 (3 packs of 30 film-coated tablets) - without blue boxOUTER CARTON BLISTER PACK 30 TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Višestruko pakiranje koje sadrži 90 (3 pakiranja svako sa po 30 tableta) (bez Plavog okvira) VANJSKA KUTIJA BLISTER PAKIRANJA
• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - (e.g. Trizivir, Triumeq or Ziagen), lamivudine or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4.
Triumeq ili Ziagen), lamivudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Rifampicin/Lamivudine
rifampicin/lamivudin
If the doctor thinks they may have been related, you will be told never again to take Kivexa, or any other medicine containing abacavir (e.g.Trizivir,Triumeq or Ziagen).
Ako liječnik misli da bi mogli biti povezani, reći će Vam da više nikad ne uzimate lijek Kivexa, ili bilo koji drugi lijek koji sadrži abakavir (npr. Trizivir, Triumeq ili Ziagen).
The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.The results showed that there was a mean (90%CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Farmakokinetika abakavira ispitivana je u bolesnika s blagim oštećenjem jetre (Child-Pugh vrijednosti 5-6) koji su primili jednokratnu dozu od 600 mg; medijan (raspon) AUC vrijednosti bio je 24,1 (10,4 do 54,8) ug.h/ml.
Cimetidine/Abacavir
cimetidin/abakavir
Baseline CD4 category 201-350 101/143 (71%)
Početna CD4 kategorija 50-100 21/40 (53%) Početna CD4 kategorija 101-200 57/85 (67%) Početna CD4 kategorija 201-350 101/143 (71%) Početna CD4 kategorija >350 71/109 (65%)
Number of Subjects Number of Virological Failures Number of OnTherapy Genotypes
Broj bolesnika Broj izostanaka virološkog odgovora Broj genotipova tijekom liječenja 40 (100%)
Hypersensitivity reactions (see also section 4.8 )
a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8 “Opis odabranih nuspojava”).
• After stopping treatment with Kivexa for reasons of a suspected HSR, Kivexa or any other medicinal product containing abacavir (e.g. Ziagen, Trizivir, Triumeq) must never be reinitiated.
• Nakon prekida liječenja lijekom Kivexa zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Kivexa niti bilo kojim drugim lijekom koji sadrži abakavir (npr. Ziagen, Trizivir, Triumeq).
Elevated creatinine, renal failure
Mokraćni sustav povišene razine kreatinina, zatajenje bubrega
V75I, F77L and F116Y, cause a high level of resistance to abacavir.
insercijski kompleks na mjestu 69 ili mutacija Q151M, koja se obično nalazi u kombinaciji s A62V, V75I, F77L i F116Y, uzrokuju visoku razinu rezistencije na abakavir.
The clinical relevance of this finding has not been determined.
Klinički značaj ovog nalaza nije određen.
Proportion of Patients in CNA30021with <50 cps/mL at Week 48 by Genotypic Sensitivity Score in OBT and Number of Baseline Mutations
Udio bolesnika u ispitivanju CNA30021 koji su u 48. tjednu imali <50 kopija/ml prema indeksu genotipske osjetljivosti u OBT i broju početnih mutacija
These have been identified either from clinical studies or post marketing surveillance.
Znakovi i simptomi te reakcije preosjetljivosti navedeni su u nastavku, a utvrđeni su ili u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
Proportions with HIV-1 RNA < 50 copies/ml (50% versus 47%) and < 400 copies/ml (54% versus 57%) at week 48 were also similar in each group (ITT population).
kopija/ml (54% prema 57%) u 48 tjednu.
None M184V alone Any one NRTI mutation Any two NRTIassociated mutations 22
Bilo koja pojedinačna mutacija NRTI Bilo koje dvije mutacije povezane s NRTI Bilo koje tri mutacije povezane s NRTI
Kivexa helps to control your condition.
Ostanite u redovitom kontaktu sa svojim liječnikom Kivexa pomaže u kontroliranju Vaše bolesti.
The clinical relevance of these findings is unknown.
Klinička značajnost ovih nalaza nije poznata.
Hypersensitivity case studies
Prikaz slučaja preosjetljivosti
Common: headache
• glavobolju
1 Major IAS-USA defined mutations to Abacavir or Lamivudine and multi-NRTI resistance associated mutations
Procjenjivao se i utjecaj glavnih mutacija definiranih prema IAS-USA na abakavir ili lamivudin, te mutacija povezanih s višestrukom-NRTI rezistencijom prema broju početnih mutacija tijekom odgovora.
Emtricitabine/Lamivudine
emtricitabin/lamivudin
Some medicines interact with Kivexa These include:
Neki lijekovi imaju interakciju s lijekom Kivexa
No studies on the effects on ability to drive and use machines have been performed.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja o učincima abakavira i lamivudina na sposobnost upravljanja vozilima i rada sa strojevima.
Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea
Često: mučnina, povraćanje, bol u abdomenu ili grčevi, proljev
NAME OF THE MEDICINAL PRODUCT Kivexa 600 mg/300 mg film-coated tablets abacavir/lamivudine
NAZIV LIJEKA Kivexa 600 mg/300 mg tablete abakavir/lamivudin
• Clinical Description of abacavir HSR
• Klinički opis reakcije preosjetljivosti na abakavir
Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
Vrlo se rijetko reakcija preosjetljivosti razvila u bolesnika koji su ponovno počeli uzimati lijekove koji sadrže abakavir, a nisu imali nijedan simptom preosjetljivosti tijekom prethodne primjene tih lijekova.
The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
Djelatne tvari u jednoj Kivexa filmom obloženoj tableti su 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
Ethanol/Lamivudine
etanol/lamivudin
Zidovudine/Lamivudine Zidovudine 300 mg single dose Lamivudine 150 mg single dose
zidovudin/lamivudin zidovudin 300 mg jedna doza lamivudin 150 mg jedna doza lamivudin: AUC ↔ zidovudin: AUC ↔
Methadone/Lamivudine
metadon/lamivudin
In pregnant women treated with lamivudine, more than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure indicate no malformative and foeto/neonatal effect.
1000 ishoda nakon izlaganja lijeku u drugom i trećem tromjesečju trudnoće ukazuju da lamivudin ne uzrokuje malformacije i da nema feto/neonatalni učinak.
• nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Ostali česti simptomi su: • mučnina, povraćanje, proljev, bol u trbuhu (abdomenu), izraziti umor.
The clinical relevance of these findings is not established.
Klinički značaj ovih nalaza nije ustanovljen.
Following multiple-dose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/ml (26%) and the mean (CV) AUC24 is 8.87 µg.h/ml (21%).
Cmax u stanju dinamičke ravnoteže iznosi 2,04 µg/ml (CV 26%), a srednji AUC24 8,87 µg.h/ml (CV
Didanosine/Lamivudine
didanozin/ lamivudin
ANTICONVULSANTS Phenobarbital/Abacavir
ANTIEPILEPTICI fenobarbital/abakavir
The subjects in the low viral load stratum remained blinded and on-study.
Bolesnici s niskim viralnim opterećenjem ostavljeni su u ispitivanju kao slijepa proba.
Tablet Coating
Ovojnica tablete:
There are conflicting data in some comparative studies with Kivexa i.e. HEAT, ACTG5202 and ASSERT:
Postoje proturječni podaci u nekim komparativnim ispitivanjima za lijek Kivexa na primjer HEAT,
ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine /Abacavir
LIJEKOVI didanozin/abakavir
Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high tested concentrations.
Ispitivanja su pokazala da visoke koncentracije abakavira danih in vitro i in vivo imaju slabi potencijal za izazivanje kromosomskih oštećenja.
In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to Kivexa plus a PI or NNRTI for 48 weeks.
U studiji ESS30008, 260 bolesnika u kojih je pri prethodnom liječenju abakavirom u dozi od 300 mg dvaput na dan i lamivudinom u dozi od 150 mg dvaput na dan uz inhibitor proteaze (IP) ili nenukleozidni inhibitor reverzne transkriptaze došlo do supresije virusa, randomizirani su tako da su
Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors.
U kliničkim izolatima bolesnika s nekontroliranom replikacijom virusa koji su prethodno liječeni drugim inhibitorima nukleozida i rezistentni su na njih, zabilježeno je klinički značajno smanjenje osjetljivosti na abakavir.
Section 4 of this leaflet.
u dijelu 4 ove Upute.
Neurological/Psychiatry
Neurološki/psihijatrijski simptomi glavobolja, parestezija
Virologic Response Based on Plasma HIV-1 RNA < 50 copies/ml ITT-Exposed Population M=F switch included
Virološki odgovor na temelju plazmatskih razina HIV-1 RNK < 50 kopija/ml
CNA109586 (ASSERT study), a multi-centre, open label, randomised study of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), each given once daily with efavirenz (EFV, 600mg) in ART naïve, HLA-B*5701 negative, HIV-1 infected adults.The virologic results are summarised in the table below:
CNA109586 (ASSERT ispitivanje) je multicentrično, otvoreno, randomizirano ispitivanje o abakavir/lamivudinu (ABC/3TC, 600mg/300mg) i tenofovir/emtricitabinu (TDF/FTC, 300mg/200mg),
No Kivexa dosage adjustment necessary.
Nije potrebno prilagođavanje doze lijeka Kivexa.
Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Ponovno uvođenje ABC-a može rezultirati puno bržom i težom reakcijom, što može biti fatalno, stoga je ponovno uvođenje kontraindicirano.
Similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline were observed, indicating that the Kivexa group was non-inferior to the abacavir plus lamivudine twice daily group (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38).
Podjednako smanjenje HIV-1 RNK, određeno prema prosječnoj površini pod krivuljom umanjenoj za početne vrijednosti, pokazuju da je skupina koja je primala lijek Kivexa jednako vrijedna kao skupina koja je primala abakavir plus lamivudin dvaput na dan (AAUCMB; -1,65 log10
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Nakon dvogodišnje primjene abakavira primijećena je blaga degeneracija miokarda u miševa i štakora.
Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Vrlo rijetke nuspojave koje se mogu pojaviti u krvnim pretragama su:
• diarrhoea
• kašalj
Similar clinical success (point estimate for treatment difference: -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
U oba režima liječenja zabilježen je sličan klinički uspjeh (ocijenjena razlika u razlici liječenja: -1,7;
Repeat-dose toxicity
Toksičnost višekratnih doza
Placental transfer of abacavir and lamivudine has been shown to occur in humans.
Pokazalo se da abakavir i lamivudin prolaze kroz placentu u ljudi.
The clinical relevance of this is unknown.
Klinički značaj ovog nalaza nije poznat.
CYTOTOXICS Cladribine/Lamivudine
CITOTOKSICI kladribin/lamivudin
Retinoid compounds (e.g. isotretinoin)/Lamivudine No drug interaction studies
Nedostatni podaci na osnovu kojih bi se preporučila prilagodba doze spojevi retinoida (npr. isotretinoin) /lamivudin Nema studija interakcije lijekova.
Very rare side effects
Manje česte nuspojave
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine .There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues: these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Postoje izvješća o poremećaju funkcije mitohondrija kod HIV- negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ova izvješća su se pretežno odnosila na liječenje režimima koji su sadržavali zidovudin.
Therapy
RETINOIDI
The safety and efficacy of Kivexa has not been established in patients with significant underlying liver disorders.
U bolesnika s ozbiljnom podležećom bolesti jetre nije ustanovljena sigurnost i djelotvornost primjene lijeka Kivexa.
(estimated hazard ratio: 2.33, 95% CI: 1.46, 3.72, p=0.0003).
0,39%; 95% CI: -6,63; 7,40).
SIDE 2
PRILOG III.
Baseline CD4 category 50-100 21/40 (53%)
000 kopija/mL Početna CD4 kategorija <50 3/6 (50%)
Zidovudine/Abacavir
zidovudin/abakavir
The proportion of treatment-experienced patients in the CAL30001 study with HIVRNA <50 copies/mL at Week 48 by genotypic sensitivity score in optimized background therapy (OBT) are tabulated The impact of major IAS-USA defined mutations to abacavir or lamivudine and multi-NRTI resistance associated mutations to the number of baseline mutations on response was also evaluated.
Udio ranije liječenih bolesnika u ispitivanju CAL30001 koji su imali HIV-RNA <50 kopija/mL u 48. tjednu, prema indeksu genotipske osjetljivosti u optimiziranom osnovnom liječenju (eng. optimized background therapy) (OBT) je tablično prikazan.
Management of ABC HSR reaction
Zbrinjavanje reakcije preosjetljivosti na ABC
The adverse reactions considered at least possibly related to abacavir or lamivudine are listed by body system, organ class and absolute frequency.
Nuspojave za koje se smatra da bi mogle biti povezane s abakavirom ili lamivudinom navedene su prema organskim sustavima i apsolutnoj učestalosti pojavljivanja definiranoj kao: vrlo česte (>1/10),
Gastrointestinal tract
Tablični prikaz nuspojava
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confer high-level resistance to lamivudine.
U bolesnika zaraženih HIV-1, koji su primali antiretrovirusnu terapiju koja uključuje lamivudin, dolazi do stvaranja varijanti M184V ili M184I.
Common: fatigue, malaise, fever.
Često: vrućica, letargija, umor Često: umor, malaksalost, vrućica
• Kivexa should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
statusom, niti u bolesnika s negativnim HLA-B*5701 statusom za koje se sumnja da su imali reakciju preosjetljivosti na abakavir tijekom prethodnog liječenja režimom koji je sadržavao abakavir (npr. Ziagen, Trizivir, Triumeq).
Other symptoms include:
Oni uključuju:
Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
GlaxoSmithKline d.o.o Tel:++385 1 6051 999
Phenytoin/Lamivudine
fenitoin/lamivudin
Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats.
Ispitivanja lamivudina na životinjama pokazala su povećanu ranu smrtnost embrija u kunića,
Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Ako Vaš liječnik nije dostupan, morate odmah zatražiti medicinsku pomoć negdje drugdje (npr. odjel hitne pomoći u najbližoj bolnici).