natgillin/translations-raw huggingface dataset:
34 Store in a refrigerator (2°C – 8°C) Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
What Tritanrix HepB contains
Kaj vsebuje cepivo Tritanrix HepB
1
- Zdravilne učinkovine v 1 odmerku (0, 5 ml) so:
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis (inactivated)2 Hepatitis B surface antigen2,3
davični toksoid1 tetanusni toksoid1 Bordetella pertussis (inaktivirana) 2 površinski antigen virusa hepatitisa B2, 3 1
2
Adsorbiran na hidratirani aluminijev hidroksid 2
adsorbed on aluminium hydroxide, hydrated
0, 26 mg
0.26 mg Al3+
Al3+
3
Adsorbiran na aluminijev fosfat 3
adsorbed on aluminium phosphate
0, 37 mg
0.37 mg Al3+
Al3+
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA
Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae)
- The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
- Pomožne snovi cepiva Tritanrix HepB so: tiomersal, natrijev klorid in voda za injekcije.
Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 1 dose (0.5 ml).
Cepivo Tritanrix HepB je na voljo v obliki bele, rahlo mlečne tekočine v stekleni viali, ki vsebuje 1 odmerek (0, 5 ml).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
35 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
36 Tel: +370 5 264 90 00 info. lt@gsk. com
Navodilo je bilo odobreno
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/ or variation of physical aspect.
Cepivo morate dobro pretresti, da nastane homogena motna bela suspenzija, in ga vizualno preveriti glede morebitne prisotnosti tujih delcev in/ ali spremenjenega fizičnega izgleda.
Tritanrix HepB suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Tritanrix HepB suspenzija za injiciranje, večodmerna adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju - celotna celica (Pw) in hepatitisu B – rekombinantno (HBV)
38 • if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine.
• če je predhodno imel kakršnokoli alergijsko reakcijo na cepivo Tritanrix HepB ali na katerokoli sestavino v tem cepivu.
The vaccine should never be given into a vein.
39 Cepivo se ne sme dajati v žilo.
39 Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Med kliničnimi preskušanji cepiva Tritanrix HepB so se pojavili naslednji neželeni učinki:
40 Store in a refrigerator (2°C – 8°C) Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
For 2 doses: pack size of 1 For 10 doses: pack size of 1
Za 10 odmerkov: pakiranje po 1.
Trizivir is a medicine containing three active substances: abacavir (300 mg), lamivudine (150 mg) and zidovudine (300 mg).
Zdravilo Trizivir je zdravilo, ki vsebuje tri zdravilne učinkovine: abakavir (300 mg), lamivudin (150 mg) in zidovudin (300 mg).
It is available as blue-green, capsule-shaped tablets.
Zdravilo je na voljo v obliki modro zelenih tablet, ki so podobne kapsulam.
Trizivir is an antiviral medicine.
Zdravilo Trizivir je protivirusno zdravilo.
It is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo se uporablja za zdravljenje odraslih, okuženih z virusom človeške imunske pomanjkljivosti (HIV), ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
It is used to replace treatment with the three components taken at doses similar to those in Trizivir.
Uporablja se za nadomestitev zdravljenja s tremi komponentami, ki se jemljejo v odmerkih, podobnih tistim v zdravilu Trizivir.
Patients should have already been taking the three active substances separately for at least six to eight weeks before switching to Trizivir.
Bolniki morajo te tri zdravilne učinkovine že jemati kot ločena zdravila vsaj šest do osem tednov pred prehodom na jemanje zdravila Trizivir.
Doctors should prescribe Trizivir after considering the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risk associated with the active substances.
Zdravniki naj zdravilo Trizivir predpišejo, potem ko presodijo ali se bo bolnik lažje držal urnika zdravljenja, pričakovano učinkovitost zdravila in tveganja, povezana z zdravilnimi učinkovinami.
They should prescribe Trizivir to patients with high levels of HIV in the blood (above 100,000 copies/ ml) only after careful consideration.
Bolnikom z visokimi ravnmi virusa HIV v krvi (nad 100. 000 kopij/ ml) bi morali zdravniki zdravilo Trizivir predpisati samo po zelo skrbnem premisleku.
Treatment with Trizivir should be initiated by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Trizivir lahko uvede le zdravnik, ki ima izkušnje z vodenjem okužbe s HIV.
The recommended dose of Trizivir for patients over 18 years of age is one tablet twice a day, with or without food.
Priporočeni odmerek zdravila Trizivir za bolnike, stare 18 let in več, je ena tableta dvakrat na dan, zaužita s hrano ali brez nje.
If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately.
Če morajo bolniki prenehati jemati abakavir, lamivudin ali zidovudin, ali morajo zaradi težav z ledvicami, jetri ali krvjo spremeniti odmerek, bodo morali jemati zdravila z ločenimi učinkovinami abakavir, lamivudin in zidovudin.
Trizivir should not be taken by patients who have problems with their liver or who have kidney failure.
Bolniki s težavami z jetri ali z odpovedjo ledvic zdravila Trizivir ne smejo jemati.
Patients who take Trizivir must be given the special alert card that summarises the key safety information about the medicine.
Bolniki, ki jemljejo zdravilo Trizivir, morajo dobiti posebno opozorilno izkaznico, ki povzema ključne varnostne podatke o zdravilu.
All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Vse tri zdravilne učinkovine zdravila Trizivir, abakavir, lamivudin in zidovudin, so zaviralci nukleozidne reverzne transkriptaze (NRTI- ji).
They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Vse učinkovine na podoben način zavirajo aktivnost encima reverzna transkriptaza, ki ga tvori virus HIV, in slednjemu omogoča okužiti celice ter tvoriti še večje število virusov.
Trizivir reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Trizivir zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged All three active substances were previously available in the European Union (EU): abacavir was granted marketing authorisation as Ziagen in 1999, lamivudine was granted marketing authorisation as Epivir in 1996, and zidovudine has been available in the EU since the mid-1980s.
Vse tri zdravilne učinkovine so bile predhodno že na voljo v Evropski uniji (EU): abakavir je dobil dovoljenje za promet pod imenom Ziagen leta 1999, lamivudin je dobil dovoljenje za promet pod imenom Epivir leta 1996, zidovudin pa je v EU na voljo od sredine osemdesetih let.
No specific clinical studies have been carried out with the combined tablet.
S to kombinirano tableto niso izvedli nobene posebne klinične študije.
The company presented the results of studies of abacavir, lamivudine and zidovudine taken together, as carried out during the development of Ziagen.
Družba je predložila rezultate študij za abakavir, lamivudin in zidovudin, ki so jih bolniki jemali sočasno in so bile izvedene med razvijanjem zdravila Ziagen.
The company also looked at the way the combined tablet was absorbed in the body in comparison to the separate tablets.
Podjetje je preiskalo tudi način, na katerega se kombinirane tablete absorbirajo v telesu v primerjavi s tabletami z ločenimi učinkovinami.
What benefit has Trizivir shown during the studies?
Kakšne koristi je zdravilo Trizivir izkazalo med raziskavami?
In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.
V študijah, ki so jih izvedli za razvoj zdravila Ziagen, se je kombinacija treh zdravilnih učinkovin pri manjšanju virusnih bremen pokazala za vsaj tako učinkovito kot primerjalne kombinacije.
The combination tablet was absorbed in the body in the same way as the separate tablets
Kombinirana tableta se je po tkivih telesa porazdelila na enak način kot tablete z ločenimi učinkovinami.
The most common effects when taking Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
Najpogostejši neželeni učinki, ki so jih opazili pri jemanju zdravila Trizivir (opaženi pri več kot enem bolniku od 10) sta bila diareja in slabost.
For the full list of all side effects reported with Trizivir, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Trizivir, glejte Navodilo za uporabo.
Hypersensitivity reactions (allergic reactions) occur in about 5% of patients taking Trizivir, usually within the first six weeks of treatment.
Reakcije preobčutljivosti (alergične reakcije) se pojavijo pri približno 5% bolnikov, ki jemljejo zdravilo Trizivir, kar se navadno zgodi v prvih šestih tednih zdravljenja.
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy and malaise (feeling unwell).
Simptomi skoraj vedno vključujejo vročino ali eksantem, zelo pogosti pa so tudi navzeja, bruhanje, diareja, trebušne bolečine, glavobol, znaki jetrnih poškodb, ki so opazni v krvi, mialgija (bolečine v mišicah), dispneja (težave z dihanjem), kašljanje, letargija in splošno slabo počutje.
Patients treated with Trizivir receive a card detailing these symptoms so that they are aware of them, and must contact their doctor immediately if they develop a reaction.
Bolniki, ki se zdravijo z zdravilom Trizivir prejmejo izkaznico, ki podrobno navaja te simptome, tako da jih poznajo, v primeru reakcije pa se morajo takoj obrniti na svojega zdravnika.
Trizivir should not be used in patients who may be hypersensitive (allergic) to lamivudine, zidovudine, abacavir or any of the other ingredients, who have problems with their liver, or who have kidney failure.
Zdravila Trizivir ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) lamivudin, zidovudin, abakavir ali katero koli drugo sestavino zdravila, in bolniki s težavami z jetri ali odpovedjo ledvic.
Because it contains zidovudine, it should also not be used by patients with low neutrophil (a type of white blood cell) counts or anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body).
Ker zdravilo vsebuje učinkovino zidovudin, ga prav tako ne smejo jemati bolniki, ki imajo nizko število nevtrofilcev (vrsta belih krvničk) ali anemijo (nizka raven hemoglobina, beljakovine v eritrocitih, ki po telesu prenaša kisik).
As with other anti-HIV medicines, patients taking Trizivir may be at risk of developing lipodystrophy (changes in the distribution of body fat), immune reactivation syndrome (reactions to disease-causing organisms by the recovering immune system) and osteonecrosis (death of cells in the bone, which makes the bones fragile).
Kot pri drugih zdravilih proti virusu HIV lahko pride tudi pri bolnikih, ki jemljejo zdravilo Trizivir, do razvoja lipodistrofije (spremembe v porazdelitvi telesnega maščevja), sindroma imunske reaktivacije (simptomi okužbe zaradi izboljšanja stanja imunskega sistema) ali osteonekroze (odmiranje celic v kostnini, zaradi česar postanejo kosti krhke).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Trizivir.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C) in jemljejo zdravilo Trizivir, se utegne povišati tveganje za poškodbe jeter.
As with all NRTIs, Trizivir may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Trizivir during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Kot vsi NRTI- ji lahko tudi zdravilo Trizivir povzroči laktacidozo (povečano količino mlečne kisline v telesu) ter mitohondrijsko disfunkcijo (poškodbe tistih delov celice, ki tvorijo energijo, kar lahko povzroči težave s krvjo) pri dojenčkih mater, ki med nosečnostjo prejemajo zdravilo Trizivir.
The Committee for Medicinal products for Human Use (CHMP) decided that Trizivir’ s benefits are greater than its risks for the treatment of HIV infection in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila Trizivir pri zdravljenju okužbe z virusom HIV pri odraslih večje od z njim povezanih tveganj.
This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages.
Ta fiksna kombinacija zamenja tri sestavine (abakavir, lamivudin in zidovudin), ki se ločeno uporabljajo v podobnih odmerkih.
The Committee noted that the reduction in the number of tablets that patients need to take may help patients to stick to their treatment, and that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who have non-advanced disease.
Odbor je ugotovil, da zmanjšanje števila tablet, ki jih morajo jemati, utegne pomagati bolnikom, da se držijo urnika zdravljenja, in da je zdravilo Trizivir koristi izkazalo predvsem pri bolnikih, ki so imeli malo ali nič predhodnih izkušenj z zdravljenjem okužbe z virusom HIV, njihova bolezen pa še ni napredovala.
The Committee recommended that Trizivir be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Trizivir.
The European Commission granted a marketing authorisation valid throughout the EU for Trizivir to Glaxo Group Ltd on 28 December 2000.
Evropska komisija je dovoljenje za promet z zdravilom Trizivir, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd. dne 28. decembra 2000.
The marketing authorisation was renewed on 28 December 2005.
Dovoljenje za promet je bilo podaljšano dne 28. decembra 2005.
The full EPAR for Trizivir is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trizivir je na voljo tukaj.
Invented name Strengths
ime
Pharmaceutical forms
Jakost
Route of administration Packaging
Farmacevtska oblika Pot uporabe Ovojnina
EU/ 1/ 00/ 156/ 002 Trizivir
EU/ 1/ 00/ 156/ 00 Trizivir
blister (opaque PVC/ Aclar)
pretisni omot (neprosojni
EU/ 1/ 00/ 156/ 003 Trizivir
EU/ 1/ 00/ 156/ 00 Trizivir
bottles (HPDE)
plastenka (HDPE)
1 Each film-coated tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg lamivudine and 300 mg zidovudine.
1 Vsaka filmsko obložena tableta vsebuje 300 mg abakavirja v obliki abakavirjevega sulfata, 150 mg lamivudina in 300 mg zidovudina.
TRIZIVIR 300 mg/ 150 mg/ 300 mg film-coated tablets
TRIZIVIR 300 mg/ 150 mg/ 300 mg filmsko obložene tablete
Each film-coated tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
Vsaka filmsko obložena tableta vsebuje 300 mg abakavirja (v obliki sulfata), 150 mg lamivudina in 300 mg zidovudina.
Blue-green capsule-shaped film-coated tablets engraved with “ GX LL1” on one side.
Modrozelene filmsko obložene tablete v obliki kapsule, na eni strani imajo odtisnjeno oznako “ GX LL1 ”.
Trizivir is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults.
Trizivir je indiciran za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV).
This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar dosages.
Ta fiksna kombinacija treh učinkovin (abakavirja, lamivudina in zidovudina) nadomešča uporabo enakih odmerkov vsake posamezne učinkovine.
It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks (see section 4.4).
Priporočljivo je, da se zdravljenje prične z abakavirjem, lamivudinom in zidovudinom kot samostojnimi zdravili, kar naj traja prvih 6 do 8 tednov (glejte poglavje 4. 4).
In patients with high viral load (> 100,000 copies/ ml) choice of therapy needs special consideration (see section 5.1).
Pri bolnikih z visoko virusno obremenitvijo (> 100. 000 kopij/ ml) je potreben še posebej skrben premislek pred izbiro zdravljenja (glejte poglavje 5. 1).
Trizivir can be taken with or without food.
Trizivir se lahko jemlje s hrano ali brez nje.
Where discontinuation of therapy with one of the active substances of Trizivir is indicated, or where dose reduction is necessary separate preparations of abacavir, lamivudine and zidovudine are available.
Če je indicirano, da se zdravljenje z eno od učinkovin Trizivirja prekine ali pa je odmerek potrebno zmanjšati, so abakavir, lamivudin in zidovudin na voljo tudi kot samostojna zdravila.
Whilst no dosage adjustment of abacavir is necessary in patients with renal dysfunction, lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance.
Medtem, ko pri bolnikih z motnjami v delovanju ledvic odmerka abakavirja ni potrebno prilagajati, pa so, zaradi manjšega očistka, koncentracije lamivudina in
2 patients with reduced renal function (creatinine clearance ≤ 50 ml/ min).
2 zidovudina pri bolnikih z oslabljenim delovanjem ledvic povečane.
Physicians should refer to the individual summary of product characteristics of these medicinal products.
Ker bo tako verjetno potrebno odmerek teh dveh učinkovin prilagoditi, je pri bolnikih z zmanjšanim delovanjem ledvic (kreatininski očistek ≤ 50 ml/ min) priporočljivo uporabljati abakavir, lamivudin in zidovudin kot samostojna zdravila.
Trizivir should not be administered to patients with end-stage renal disease (see sections 4.3 and 5.2).
Zdravilo Trizivir se ne sme dajati bolnikom s terminalnim stadijem ledvične bolezni (glejte poglavji 4. 3 in 5. 2).
Trizivir is contra-indicated in patients with hepatic impairment (see sections 4.3 and 5.2).
Trizivir je kontraindiciran pri bolnikih, ki imajo jetrno okvaro (glejte poglavji 4. 3 in 5. 2).
As dosage adjustment of Trizivir is not possible, separate preparations of abacavir, lamivudine and zidovudine should be used.
Ker z zdravilom Trizivir prilagajanje odmerka posamezne učinkovine ni možno, je potrebno uporabiti abakavir, lamivudin in zidovudin kot samostojna zdravila.
Trizivir is contraindicated in patients with known hypersensitivity to abacavir, lamivudine or zidovudine, or to any of the excipients.
Trizivir je kontraindiciran pri bolnikih z znano preobčutljivostjo za abakavir, lamivudin ali zidovudin oziroma katerokoli pomožno snov.
See BOXED INFORMATION ON HYPERSENSITIVITY REACTIONS in section 4.4 and section 4.8.
Glejte PODATKE O PREOBČUTLJIVOSTNIH REAKCIJAH V OKVIRU v poglavju 4. 4 in poglavju 4. 8.
Trizivir is contraindicated in patients with end-stage renal disease.
Trizivir je kontraindiciran pri bolnikih s terminalnim stadijem ledvične bolezni.
Trizivir is contraindicated in patients with hepatic impairment.
Trizivir je kontraindiciran pri bolnikih, ki imajo jetrno okvaro.
Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 109/ l), or abnormally low haemoglobin levels (< 7.5 g/ dl or 4.65 mmol/ l) (see section 4.4).
Zaradi učinkovine zidovudin je zdravilo Trizivir kontraindicirano pri bolnikih z izredno nizkim številom nevtrofilcev (< 0, 75 x 109/ l) ali izredno nizkimi vrednostmi hemoglobina (< 7, 5 g/ dl ali 4, 65 mmol/ l) (glejte poglavje 4. 4).
Hypersensitivity Reaction (see also section 4.8):
Preobčutljivostna reakcija (glejte tudi poglavje 4. 8):
In clinical studies approximately 5% of subjects receiving abacavir (which is also the active substance of Ziagen) develop a hypersensitivity reaction.
V kliničnih študijah se je pri okoli 5% oseb, ki so prejemale abakavir (ki je tudi učinkovina v zdravilu Ziagen) pojavila preobčutljivostna reakcija.
Some of these cases were life-threatening and resulted in a fatal outcome despite taking precautions.
Nekateri od teh primerov so bili življenjsko nevarni in so se kljub ukrepanju končali smrtno.
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.
Na osnovi podatkov prospektivne študije CNA106030 (PREDICT- 1) se je pri presejalnem testiranju za prisotnost alela HLA- B* 5701 pred uvedbo zdravljenja in posledičnemu izogibanju uporabe abakavirja pri bolnikih s tem alelom pojavnost preobčutljivostnih reakcij na abakavir pomembno zmanjšala.
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.
3 Posledično je pred uvedbo zdravljenja z abakavirjem pri vsakem bolniku, okuženim z virusom HIV, treba opraviti presejalni test za prisotnost alela HLA- B* 5701, ne glede na rasno poreklo.
3 In any patient treated with abacavir, the clinical diagnosis of suspected hypersensitivity reaction must remain the basis of clinical decision-making.
Pri vsakem bolniku, ki se zdravi z abakavirjem, mora klinična diagnoza suma na preobčutljivostno reakcijo ostati osnova za klinično odločanje.
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 for a severe or even fatal reaction.
Zaradi možne hude in celo usodne reakcije je torej tudi v primeru odsotnosti alela HLA- B* 5701 pomembno, da se zdravljenje z abakavirjem trajno prekine in se ga nikoli več ne uvede, če se preobčutljivostne reakcije na klinični osnovi ne more izključiti.
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.
V študiji PREDICT- 1 so kot raziskovalno orodje uporabljali kožni test z obliži, ki pa je za klinično obravnavo bolnikov brez koristi in se ga zato v klinični praksi ne sme uporabljati.
Hypersensitivity reactions are characterised by the appearance of symptoms indicating multi-organ system involvement.
Za preobčutljivostne reakcije je značilen pojav simptomov, ki kažejo na prizadetost večih organskih sistemov.
Almost all hypersensitivity reactions will have fever and/ or rash as part of the syndrome.
Pri skoraj vseh preobčutljivostnih reakcijah kot del sindroma nastopi vročina in/ ali eksantem.