natgillin/translations-raw huggingface dataset:
The effects of VIRAMUNE have also been studied in two studies including 478 children, taken alone or in combination with one or two other antiviral medicines.
Učinke zdravila VIRAMUNE so preučevali tudi v dveh raziskavah s 478 otroki, pri čemer je bilo zdravilo dajano samostojno ali v kombinaciji z enim ali dvema drugima protivirusnima zdraviloma.
The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and in the number of CD4 T-cells in the blood (CD4 cell count), and the proportion of patients whose disease worsened or who died.
Glavni merili učinkovitosti sta bili sprememba koncentracije virusa HIV v krvi (virusne obremenitve) in števila T- celic CD4 v krvi (koncentracije celic CD4) ter delež bolnikov, pri katerih se je bolezen poslabšala ali so umrli.
CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV.
T- celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendar pa jih virus HIV ubija.
What benefit has VIRAMUNE shown during the studies?
Kakšne koristi je zdravilo VIRAMUNE izkazalo med raziskavami?
VIRAMUNE, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines.
Zdravilo VIRAMUNE, dajano v kombinaciji z dvema drugima protivirusnima zdraviloma, je bilo učinkovitejše od kombinacij dveh zdravil.
In 398 treatment-experienced adults (who had taken treatment for HIV infection before), VIRAMUNE, in combination with zidovudine and lamivudine, led to a 38% reduction in viral loads after 48 weeks, compared to a 28% rise in those taking zidovudine and lamivudine.
Pri 398 predhodno zdravljenih odraslih (ki so že prej jemali zdravila proti okužbi s HIV) je zdravilo VIRAMUNE v kombinaciji z zidovudinom in lamivudinom privedlo do 38% zmanjšanja virusnih obremenitev po 48 tednih v primerjavi z 28% povečanjem pri bolnikih, ki so jemali zidovudin in lamivudin.
In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral loads fell by 99% in the three-medicine group, compared to 96% in the two-medicine group after 40 to 52 weeks.
Pri 151 predhodno nezdravljenih bolnikih (ki prej še niso jemali zdravil proti okužbi s HIV) so se po 40 do 52 tednih virusne obremenitve v skupini, ki je jemala tri zdravila, zmanjšale za 99% v primerjavi s 96% v skupini, ki je jemala dve zdravili.
Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or dying.
Pri odraslih, ki so jemali tri zdravila, je bil tudi porast koncentracije celic CD4 večji in tveganje za poslabšanje bolezni ali smrt manjše.
Similar results were seen in HIV-1-infected children.
Podobni rezultati so bili opaženi pri otrocih, okuženih s HIV- 1.
What is the risk associated with VIRAMUNE?
Kakšna tveganja so povezana z zdravilom VIRAMUNE?
The most common side effects when taking VIRAMUNE (seen in between 1 and 10 patients in 100) are rash, allergic reactions, headache, nausea (feeling sick), hepatitis (inflammation of the liver) and signs of liver problems in the blood.
Najpogostejši neželeni učinki pri jemanju zdravila VIRAMUNE (opaženi pri 1 do 10 bolnikih izmed 100) so izpuščaji, alergijske reakcije, glavobol, slabost, hepatitis (vnetje jeter) in znaki težav z jetri v krvi.
VIRAMUNE has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions.
Z zdravilom VIRAMUNE so povezani tudi resni neželeni učinki, med drugim Stevens - Johnsonov sindrom in toksična epidermalna nekroliza (življenjsko nevarne alergijske reakcije, ki prizadenejo kožo in sluznico), resni hepatitis in jetrna odpoved ter resne alergijske reakcije.
For the full list of all side effects reported with VIRAMUNE, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila VIRAMUNE, glejte Navodilo za uporabo.
VIRAMUNE should not be used in people who may be hypersensitive (allergic) to nevirapine or any of the other ingredients, or who have severe problems with their liver or signs of liver problems in the blood.
Zdravilo VIRAMUNE se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) nevirapin ali katero drugo sestavino, imajo resne težave z jetri ali znake v krvi, ki kažejo na težave z jetri.
It should not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression).
Ne sme se uporabljati pri bolnikih, ki jemljejo šentjanževko (zeliščni pripravek, namenjen za zdravljenje depresije).
Its use in patients taking rifampicin (used to treat tuberculosis) is not recommended.
Njegova uporaba pri bolnikih, ki jemljejo rifampicin (namenjen za zdravljenje tuberkuloze), ni priporočljiva.
Treatment with VIRAMUNE should not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who have had signs of liver problems while they were taking VIRAMUNE that returned when the medicine was started again.
Zdravljenje z zdravilom VIRAMUNE se ne sme ponovno začeti pri bolnikih, ki so morali prenehati jemati zdravilo zaradi izpuščajev, alergijskih reakcij ali hepatitisa oz. so imeli med jemanjem zdravila VIRAMUNE znake težav z jetri, ki so se ob ponovnem jemanju zdravila ponovili.
Caution is needed when VIRAMUNE is taken at the same time as other medicines.
Pri jemanju zdravila VIRAMUNE hkrati z drugimi zdravili je potrebna previdnost.
As with other anti-HIV medicines, patients taking VIRAMUNE may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki jemljejo zdravilo VIRAMUNE, tveganje za lipodistrofijo (spremembe v porazdelitvi telesne maščobe), osteonekrozo (odmiranje kostnega tkiva) ali sindrom imunske reaktivacije (simptome okužbe, ki jo povzroči imunski sistem med okrevanjem).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking VIRAMUNE.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravila VIRAMUNE povečano tveganje za poškodbe jeter.
Why has VIRAMUNE been approved?
Zakaj je bilo zdravilo VIRAMUNE odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that VIRAMUNE’ S benefits are greater than its risks as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila VIRAMUNE kot del kombinirane terapije za protivirusno zdravljenje bolnikov, okuženih s HIV- 1, z napredovalo ali napredujočo imunsko pomanjkljivostjo, večje od z njim povezanih tveganj.
Most of the experience with VIRAMUNE was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Večina izkušenj z zdravilom VIRAMUNE izvira iz kombiniranega zdravljenja z zaviralci nukleozidne reverzne transkriptaze (NRTI- ji, vrsta protivirusnega zdravila).
There was also insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after VIRAMUNE treatment.
Prav tako je bilo na voljo premalo podatkov o kombiniranem zdravljenju z zaviralcem proteaze (druga vrsta protivirusnega zdravila) po zdravljenju z zdravilom VIRAMUNE.
The committee recommended that VIRAMUNE be given marketing authorisation.
Odbor je priporočil, da se za zdravilo VIRAMUNE odobri dovoljenje za promet.
This summary was last updated in 02-2007.
Druge informacije o zdravilu VIRAMUNE:
EU/ 1/ 97/ 055/ 001
Številka EU EU/ 1/ 97/ 055/ 001
Viramune
zaščiteno ime Viramune
200 mg
jakost 200 mg
blister (PVC/ alu)
ovojnina pretisni omot (PVC/ Alu)
60 tablets
velikost pakiranja 60 tablet
50 mg/ 5 ml 200 mg 200 mg
50 mg/ 5 ml peroralna suspenzija
bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu)
steklenica (HDPE)
1 bottle + 5 ml measuring syringe 120 tablets 14 tablets
1 steklenica + 5 ml merilna brizga
1 1.
A 1 1.
VIRAMUNE 200 mg tablets
VIRAMUNE 200 mg tablete
Each tablet contains 200 mg of nevirapine (as anhydrate).
Ena tableta vsebuje 200 mg nevirapina (v obliki anhidrata).
Excipient: each tablet contains 318 mg of lactose monohydrate.
Pomožna snov: ena tableta vsebuje 318 mg laktoze monohidrata.
One side is embossed with the code “ 54 193”, with a single bisect separating the “ 54” and “ 193”.
Na eni strani tablete je reliefna oznaka ''54 193'', pri kateri sta ''54'' in ''193'' na sredini ločeni z enojno zarezo.
The tablet should not be divided.
Tablete ne smete deliti.
VIRAMUNE is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4.).
(glejte poglavje 4. 4.).
Most of the experience with VIRAMUNE is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Večina izkušenj z VIRAMUNOM izvira iz kombiniranega dajanja z zaviralci nukleozidne in nukleotidne reverzne transkriptaze (NRTI).
The choice of a subsequent therapy after VIRAMUNE should be based on clinical experience and resistance testing (see section 5.1).
(glejte poglavje 5. 1.).
VIRAMUNE should be administered by physicians who are experienced in the treatment of HIV infection.
VIRAMUNE lahko dajejo zdravniki, ki imajo izkušnje z zdravljenjem okužbe s HIV.
Patients 16 years and older
Bolniki, 16- letni in starejši
The recommended dose of VIRAMUNE is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Priporočeni odmerek VIRAMUNA je ena tableta po 200 mg na dan prvih 14 dni (tako uvajalno obdobje je treba upoštevati, ker so ugotovili, da zmanjša pogostnost izpuščaja), nato sledi jemanje ene tablete po 200 mg 2- krat na dan, v kombinaciji z najmanj dvema dodatnima protivirusnima zdraviloma.
Paediatric (adolescent) patients
Otroci (mladostniki)
VIRAMUNE 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Tablete VIRAMUNE po 200 mg so po zgoraj opisani shemi odmerjanja primerne za večje otroke, zlasti mladostnike, ki so mlajši od 16 let in težji od 50 kg ali katerih telesna površina je večja od 1, 25 m2 po Mostellerjevi formuli.
An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the Summary of Product Characteristics of VIRAMUNE oral suspension).
Za otroke iz te starostne skupine, ki tehtajo manj kot 50 kg ali katerih telesna površina je manjša od 1, 25 m2, je na voljo peroralna suspenzija, katere odmerek lahko prilagajamo telesni masi ali površini (poglejte v Povzetek glavnih značilnosti peroralne suspenzije VIRAMUNE).
VIRAMUNE may be taken with or without food.
VIRAMUNE lahko bolniki jemljejo s hrano ali brez.
2 Renal impairment For patients with renal dysfunction requiring dialysis an additional 200 mg dose of VIRAMUNE following each dialysis treatment is recommended.
2 Ledvična okvara Pri bolnikih z ledvično disfunkcijo, ki se zdravijo z dializo, priporočamo dodaten odmerek VIRAMUNA po 200 mg po vsaki dializi.
Patients with CLcr ≥ 20 ml/ min do not require a dose adjustment, see section 5.2.
Bolnikom s CLcr ≥ 20 ml/ min odmerka ni treba prilagajati; glejte poglavje 5. 2.
Hepatic impairment VIRAMUNE should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Jetrna okvara VIRAMUNA ne smemo dajati bolnikom s hudo jetrno okvaro (Child- Pugh C., glejte poglavje 4. 3).
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
(glejte poglavji 4. 4 in 5. 2).
VIRAMUNE has not been specifically investigated in patients over the age of 65.
VIRAMUNA niso posebej preskušali pri bolnikih nad 65 let.
Patients experiencing rash during the 14-day lead-in period of 200 mg/ day should not have their VIRAMUNE dose increased until the rash has resolved.
Bolnikom, pri katerih se med 14- dnevnim uvajalnim obdobjem z odmerki po 200 mg na dan pojavi izpuščaj, odmerka VIRAMUNA ne smemo povečati, dokler izpuščaj ne mine.
The isolated rash should be closely monitored (please refer to section 4.4).
Posamezna mesta z izpuščajem je treba natančno opazovati (preberite poglavje 4. 4).
Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.
Bolniki, ki prekinejo jemanje VIRAMUNA za več kot 7 dni, ga morajo začeti ponovno jemati po priporočeni shemi odmerjanja in upoštevati dvotedensko uvajalno obdobje.
For toxicities that require interruption of VIRAMUNE therapy, see section 4.4.
Toksični učinki, zaradi katerih je treba zdravljenje z VIRAMUNOM prekiniti, so navedeni v poglavju 4. 4.
VIRAMUNE must not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
VIRAMUNA ne smemo ponovno dajati bolnikom, pri katerih je bilo treba zdravljenje z njim dokončno ukiniti zaradi hudega izpuščaja, izpuščaja s sočasnimi splošnimi simptomi, preobčutljivostnih reakcij ali klinične oblike hepatitisa zaradi nevirapina.
VIRAMUNE must not be used in patients with severe hepatic impairment (Child-Pugh C) or pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN.
VIRAMUNA ne smemo dajati bolnikom s hudo jetrno okvaro (Child- Pugh C) in tistim, ki so pred zdravljenjem imeli raven aspartat- aminotransferaze (ASAT) ali alanin- aminogransferaze (ALAT) > 5- krat večjo od zgornje meje normalne laboratorijske vrednosti, dokler se njuna začetna vrednost ne stabilizira na < 5- kratni zgornji meji normalne vrednosti.
VIRAMUNE must not be readministered in patients who previously had ASAT or ALAT > 5 ULN during VIRAMUNE therapy and had recurrence of liver function abnormalities upon readministration of VIRAMUNE (see section 4.4).
VIRAMUNA ne smemo ponovno dajati bolnikom, ki so imeli raven ASAT ali ALAT med prejšnjim zdravljenjem s tem zdravilom > 5- krat večjo od zgornje meje normalne laboratorijske vrednosti in pri katerih so se motnje jetrne funkcije ob ponovnem dajanju VIRAMUNA ponovile (glejte poglavje 4. 4).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking VIRAMUNE due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
Med jemanjem VIRAMUNA bolnik ne sme jemati zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), ker lahko zmanjšajo koncentracijo nevirapina v plazmi in njegove klinične učinke (glejte poglavje 4. 5).
VIRAMUNE should only be used with at least two other antiretroviral agents (see section 5.1).
VIRAMUNE smemo uporabljati samo hkrati z najmanj dvema drugima protivirusnima zdraviloma (glejte poglavje 5. 1).
VIRAMUNE should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
VIRAMUNA ne smemo uporabljati kot edino aktivno protiretrovirusno zdravilo, ker se je pokazalo, da se pri monoterapiji s katerimkoli protiretrovirusnim zdravilom razvije virusna odpornost.
3 The first 18 weeks of therapy with VIRAMUNE are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) or serious hepatitis/ hepatic failure.
Stevens- Johnsonov sindrom (SJS) in toksično epidermalno nekrolizo (TEN)) ali resen hepatitis oz. jetrno odpoved.
The greatest risk of hepatic events and skin reactions occurs in the first 6 weeks of therapy.
Nevarnost jetrnih dogodkov in kožnih reakcij je največja prvih 6 tednov zdravljenja.
However, the risk of any hepatic event continues past this period and monitoring should continue at frequent intervals.
Tveganje jetrnih dogodkov je možno tudi po tem obdobju, zato je treba s pogostim spremljanjem nadaljevati.
Female gender and higher CD4 counts at the initiation of therapy place patients at greater risk of hepatic adverse events.
Pri ženskah in bolnikih z večjim številom celic CD4 je na začetku zdravljenja povečano tveganje neželenih učinkov na jetra.
Unless the benefit outweighs the risk VIRAMUNE should not be initiated in adult females with CD4 cell counts greater than 250 cells/ mm3 or in adult males with CD4 cell counts greater than 400 cells/ mm3.
Zdravljenje z VIRAMUNOM smemo pri odraslih ženskah s številom celic CD4 nad 250 celic/ mm3 in odraslih moških s številom celic CD4 nad 400 celic/ mm3 uvesti samo, kadar je koristnost takšnega zdravljenja večja od njegovega tveganja.
This is based on the occurrence of serious and life threatening hepatotoxicity in controlled and uncontrolled studies.
To temelji na pojavu resnih in življenjsko nevarnih toksičnih učinkov na jetra v nadzorovanih in nenadzorovanih raziskavah.
Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue VIRAMUNE and seek medical evaluation immediately.
Bolniki, pri katerih se razvijejo znaki ali simptomi hepatitisa, huda kožna reakcija ali preobčutljivostne reakcije, morajo prenehati jemati VIRAMUNE, njihovo stanje pa mora nemudoma oceniti zdravnik.
Viramune must not be restarted following severe hepatic, skin or hypersensitivity reactions (see section 4.3).
Po hudih jetrnih, kožnih ali preobčutljivostnih reakcijah VIRAMUNA ne smemo ponovno uvesti (glejte poglavje 4. 3).
The dosage must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Natančno je treba upoštevati navodila o odmerjanju, zlasti 14- dnevno uvajalno obdobje (glejte poglavje 4. 2).
Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE mainly during the first 6 weeks of therapy.
Pri z VIRAMUNOM zdravljenih bolnikih so se (pretežno prvih 6 tednov zdravljenja) pojavile hude in življenjsko nevarne kožne reakcije, tudi s smrtnim izidom.
These have included cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Gre za primere Stevens- Johnsonovega sindroma, toksične epidermalne nekrolize in preobčutljivostnih reakcij, za katere so bili značilni izpuščaj, splošni simptomi in prizadetost visceralnih organov.
Patients should be closely monitored if an isolated rash occurs.
Zato je treba bolnike prvih 18 tednov zdravljenja skrbno spremljati in natančno opazovati, če se pojavi izoliran izpuščaj.
VIRAMUNE must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
VIRAMUNE moramo dokončno ukiniti vsem bolnikom, pri katerih so se pojavili hud izpuščaj ali izpuščaj ob hkratnih splošnih simptomih (npr. vročini, mehurčkih, lezijah v ustni votlini, konjunktivitisu, obraznem edemu, mišičnih ali sklepnih bolečinah ali splošnem slabem počutju), vključujoč Stevens- Johnsonov sindrom ali toksično epidermalno nekrolizo.
VIRAMUNE must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction), see section 4.4.
VIRAMUNE je treba trajno ukiniti tudi vsem bolnikom, pri katerih se je pojavila preobčutljivostna reakcija (z izpuščajem in splošnimi simptomi ob hkratni prizadetosti visceralnih organov, npr. hepatitisu, eozinofiliji, granulocitopeniji in motnjah ledvične funkcije); glejte poglaje 4. 4.
VIRAMUNE administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Dajanje večjih od priporočenih odmerkov VIRAMUNA lahko poveča pogostnost in resnost kožnih reakcij, kot sta Stevens- Johnsonov sindrom in toksična epidermalna nekroliza.
Rhabdomyolysis has been observed in patients experiencing skin and/ or liver reactions associated with VIRAMUNE use.
Pri bolnikih, pri katerih so se v povezavi z VIRAMUNOM pojavile kožne ali jetrne reakcije, so opažali rabdomiolizo.
Concomitant prednisone use (40 mg/ day for the first 14 days of VIRAMUNE administration) has been shown not to decrease the incidence of VIRAMUNE-associated rash, and may be associated with an increase in incidence and severity of rash during the first 6 weeks of VIRAMUNE therapy.
Pokazalo se je, da sočasna uporaba prednizona (40 mg na dan prvih 14 dni zdravljenja z VIRAMUNOM) ne zmanjša pogostnosti izpuščaja, ki ga povzroča VIRAMUNE, možno pa je, da je povezana s povečano pogostnostjo in resnostjo izpuščaja prvih 6 tednov zdravljenja z VIRAMUNOM.
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily during the lead-in period and a long delay between the initial symptoms and medical consultation.
Znanih je nekaj dejavnikov tveganja za razvoj resnih kožnih reakcij, med njimi neupoštevanje začetnega odmerjanja po 200 mg na dan v uvajalnem obdobju zdravljenja in daljši odlog od pojava prvih simptomov do obiska zdravnika.
Women appear to be at higher risk than men of developing rash, whether receiving VIRAMUNE or non-VIRAMUNE containing therapy.
Kaže, da je tveganje pojava izpuščaja pri ženskah večje kot pri moških ne glede na to, ali prejemajo zdravljenje, ki vključuje VIRAMUNE, ali takšno, ki ga ne vsebuje.
Patients should be instructed that a major toxicity of VIRAMUNE is rash.
Bolnikom je treba povedati, da je glavni toksični pojav pri VIRAMUNU izpuščaj.
The majority of rashes associated with VIRAMUNE occur within the first 6 weeks of initiation of therapy.
Izpuščaj, ki je povezan z VIRAMUNOM, se večinoma pojavi v prvih 6 tednih po začetku zdravljenja.
Therefore, patients should be monitored carefully for the appearance of rash during this period.
Povedati
Patients should be instructed that dose escalation is not to occur if any rash occurs during the two-week lead-in dosing period, until the rash resolves.
4 jim moramo, da odmerka ne smemo povečati, če se med dvotedenskim uvajalnim obdobjem pojavi kakršenkoli izpuščaj, vse dokler le- ta ne mine.
4 Any patient experiencing severe rash or a rash accompanied by constitutional symptoms such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise should discontinue the medicinal product and immediately seek medical evaluation.
Bolniki, pri katerih se pojavi hud izpuščaj ali izpuščaj ob hkratnih splošnih simptomih, kot so vročina, pojav mehurčkov, lezije v ustni votlini, konjunktivitis, obrazni edem, mišične ali sklepne bolečine ali splošno slabo počutje, morajo prekiniti z jemanjem zdravila, njihovo stanje pa mora nemudoma oceniti zdravnik.
In these patients VIRAMUNE must not be restarted.
Pri teh bolnikih zdravljenja z VIRAMUNOM ne smemo ponoviti.
If patients present with a suspected VIRAMUNE-associated rash, liver function tests should be performed.
Bolnikom, pri katerih sumimo, da imajo z VIRAMUNOM povezan izpuščaj, moramo opraviti preiskave jetrne funkcije.