natgillin/translations-raw huggingface dataset:
Otherwise patients with CLcr ≥ 20 ml/ min do not require an adjustment in VIRAMUNE dosing.
Bolnikom s CLcr ≥ 20 ml/ min odmerka VIRAMUNA sicer ni treba prilagajati.
Hepatic dysfunction: A steady state study comparing 46 patients with mild (n=17:
Motnje jetrne funkcije:
Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
Opravili so študijo stanja dinamičnega ravnovesja, v kateri je sodelovalo 46 bolnikov, ki so imeli: blago (n = 17: ocena 1 do 2 po Ishaku), zmerno (n = 20; ocena 3 do 4 po Ishaku) ali hudo (n = 9; ocena 5 do 6 po Ishaku, Child- Pugh A pri 8 bolnikih, pri 1 bolniku ocene po Child - Pughu niso uporabili) jetrno fibrozo, ki je veljala kot merilo za jetrno okvaro.
The patients studied were receiving antiretroviral therapy containing Viramune 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
Bolniki so v sklopu protiretrovirusnega zdravljenja prejemali VIRAMUNE v odmerkih po 200 mg, dvakrat na dan, najmanj 6 tednov pred jemanjem vzorcev za farmakokinetičnim vzorčenjem.
However, approximately 15% of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ ml (2 fold the usual mean trough).
Toda pri približno 15% bolnikov z jetrno fibrozo je bila koncentracija nevirapina pred naslednjim odmerkom večja od 9, 000 ng/ ml (2- kratna običajna srednja koncentracija pred naslednjim odmerkom).
Patients with hepatic impairment should be monitored carefully for evidence of drug induced toxicity.
Bolnike z jetrno okvaro je treba skrbno spremljati, da bi odkrili znake toksičnosti zdravila.
In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Ugotovili so, da se je pri enem bolniku po Child- Pugh B in z ascitesom pomembno povečal AUC, kar kaže na nevarnost kopičenja nevirapina v sistemskem obtoku pri bolnikih s poslabšanim jetrnim delovanjem in ascitesom.
Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section 4.4).
Nevirapin ob večkratnem odmerjanju inducira svoje lastno presnavljanje, zato ta študija, v kateri so uporabili enkratno odmerjanje, ni pokazala vpliva jetrne okvare na farmakokinetiko, kot se sicer dogaja ob večkratnem dajanju zdravila (glejte poglavje 4. 4).
In the multinational 2NN study, a population pharmacokinetic substudy of 1077 patients was performed that included 391 females.
V sklopu večdržavne študije 2NN so izvedli populacijsko farmakokinetično podštudijo, ki je zajela 1077 bolnikov, od tega 391 žensk.
Female patients showed a 13.8% lower clearance of nevirapine than did male patients.
Pri ženskah je bil nevirapinov očistek za 13, 8% nižji kot pri moških.
Nevirapine pharmacokinetics in HIV-1 infected adults do not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Kaže, da se farmakokinetika nevirapina pri s HIV- 1 okuženih odraslih s starostjo (v razponu od 19 do 68 let) ne spreminja in je enaka pri različnih rasah (črncih, prebivalcih latinskega izvora, belcih).
VIRAMUNE has not been specifically investigated in patients over the age of 65.
Z VIRAMUNOM niso izvajali specifičnih raziskav pri starejših bolnikih od 65 let.
Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric trial in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
48- tedenskega preskušanja pri otrocih iz Južne Afrike (BI 1100. 1368), v kateri je sodelovalo 123 HIV- 1- pozitivnih bolnikov, starih od 3 mesece do 16 let, ki še niso bili zdravljeni s protiretrovirusnim zdravilom, in zbirne analize petih protokolov PACTG (Paediatric AIDS Clinical Trials Group), ki so zajeli 495 bolnikov, starih od 14 dni do 19 let.
20 The results of the 48 week analysis of the South African study BI 1100.1368 confirmed that the 4/ 7 mg/ kg and 150 mg/ m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naïve paediatric patients.
19 Izsledki 48- tedenske analize južnoafriškega preskušanja BI 1100. 1368 so potrdili, da je prenašanje nevirapina v odmerkih po 4/ 7 mg/ kg in 150 mg/ m2 dobro in da so učinkoviti pri zdravljenju otrok, ki se še niso zdravili s protiretrovirusnim zdravilom.
A marked improvement in the CD4+ cell percent was observed through week 48 for both dose groups.
Do 48. tedna se je v obeh skupinah z različnima odmerkoma znatno izboljšal odstotek celic CD4+.
Also, both dosing regimens were effective in reducing the viral load.
Poleg tega sta oba režima odmerjanja učinkovito zmanjšala virusno breme.
In this 48 week study no unexpected safety findings were observed in either dosing group.
V tej 48- tedenski raziskavi v nobeni skupini niso zasledili nepričakovanih izsledkov, povezanih z varnostjo.
Pharmacokinetic data on 33 patients (age range 0.77 – 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
Farmakokinetični podatki o 33 bolnikih (starostni razpon 0, 77- 13, 7 leta) v intenzivni vzorčni skupini so pokazali, da se očistek nevirapina veča s starostjo, skladno s povečevanjem telesne površine.
Dosing of nevirapine at 150 mg/ m2 BID (after a two-week lead in at 150 mg/ m2 QD) produced geometric mean or mean trough nevirapine concentrations between 4- 6 µg/ ml (as targeted from adult data).
Po odmerjanje nevirapina dvakrat dnevno po 150 mg/ m2 (po dvotedenskem uvajanju z odmerki po 150 mg/ m2 vsak dan) je bila geometrična sredina koncentracije nevirapina ali njegova najmanjša srednja koncentracija 4 - 6 µg/ ml (ciljna glede na podatke za odrasle).
Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Neklinični podatki iz standardnih raziskav o varnosti, farmakologiji, toksičnosti ponovljenih odmerkov in genotoksičnosti niso odkrili posebnega tveganja za človeka, ki bi se razlikovalo od tistega, ki so ga pokazale klinične raziskave.
In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Pri raziskavah o toksičnih učinkih na razmnoževanje so odkrili škodljive učinke na plodnost pri podganah.
Microcrystalline cellulose Lactose monohydrate Povidone K25 Sodium starch glycolate Colloidal silicon dioxide Magnesium stearate
mikrokristalna celuloza laktoza monohidrat povidon K25 natrijev karboksimetilškrob koloidni silicijev dioksid magnezijev stearat
Treatment initiation pack:
Pakiranje za začetno zdravljenje:
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 7 tablets).
Pretisni omoti iz polivinilklorida (PVC) in aluminijaste folije (7 tablet v pretisnem omotu).
Cartons containing 2 blister cards (14 tablets).
20 Škatle vsebujejo 2 pretisna trakova (14 tablet).
21 Maintenance packs:
Pakiranja za vzdrževalno zdravljenje:
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 10 tablets).
Pretisni omoti iz polivinilklorida (PVC) in aluminijaste folije (10 tablet v pretisnem omotu).
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Nemčija
EU/ 1/ 97/ 055/ 001 (60 tablets) EU/ 1/ 97/ 055/ 003 (120 tablets) EU/ 1/ 97/ 055/ 004 (14 tablets)
EU/ 1/ 97/ 055/ 001 (60 tablet) EU/ 1/ 97/ 055/ 003 (120 tablet) EU/ 1/ 97/ 055/ 004 (14 tablet)
5 February 1998 Date of latest renewal:
5. februar 1998 Datum zadnjega podaljšanja dovoljenja za promet:
VIRAMUNE 50 mg/ 5 ml oral suspension
VIRAMUNE 50 mg/ 5 ml peroralna suspenzija
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
En ml peroralne suspenzije vsebuje 10 mg nevirapina (v ogliki hemihidrata).
Each bottle contains 2.4 g of nevirapine.
Ena steklenička vsebuje 2, 4 g nevirapina.
Excipient: each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
En ml peroralne suspenzije vsebuje 150 mg saharoze, 162 mg sorbitola, 1, 8 mg metilparahidroksibenzoata in 0, 24 mg propilparahidroksibenzoata.
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 nukleozidnimi zaviralci reverzne transkriptaze (NRTI).
The choice of a subsequent therapy after VIRAMUNE should be based on clinical experience and resistance testing (see section 5.1).
Izbira zdravila, ki ga bomo uporabili po VIRAMUNU, mora temeljiti na kliničnih izkušnjah in preskusu odpornosti (glejte poglavje 5. 1.).
VIRAMUNE should be administered by physicians who are experienced in the treatment of HIV infection.
VIRAMUNE lahko dajejo le zdravniki, ki imajo izkušnje z zdravljenjem okužbe s HIV.
Paediatric patients
Otroci
VIRAMUNE may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows:
Zdravilo VIRAMUNE otrokom odmerjamo glede na telesno površino ali telesno maso na naslednji način:
By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/ m2 once daily for two weeks followed by 150 mg/ m2 twice daily thereafter.
Priporočeni peroralni odmerek za otroke vseh starosti, določen na podlagi telesne površine po Mostellerjevi formuli je 150 mg/ m2 enkrat na dan, dva tedna, nato sledi odmerjanje 150 mg/ m2 dvakrat na dan.
23 Calculation of the volume of Viramune® oral suspension (50 mg/ 5 ml) required for paediatric dosing on a body surface basis of 150 mg/ m2:
Izračun volumna peroralne suspenzije VIRAMUNE (50 mg/ 5 ml), potrebnega za odmerjanje pri otrocih, določen na podlagi telesne površine 150 mg/ m2:
BSA range (m2) 0.08 – 0.25 0.25 – 0.42 0.42 – 0.58 0.58 – 0.75 0.75 – 0.92 0.92 – 1.08 1.08 – 1.25 1.25+
22
Volume (ml) 2.5 5 7.5 10 12.5 15 17.5 20
Razpon telesne površine (m2)
BSA (m2) =
Volumen (ml)
Height
2, 5 5 7, 5 10 12, 5 15 17, 5 20
By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/ kg once daily for two weeks followed by 7 mg/ kg twice daily thereafter.
Na podlagi telesne mase določeni odmerek za otroke do 8. leta starosti je 4 mg/ kg enkrat na dan, dva tedna, nato sledi odmerjanje 7 mg/ kg dvakrat na dan.
For patients 8 years and older the recommended dose is 4 mg/ kg once daily for two weeks followed by 4 mg/ kg twice daily thereafter.
Za otroke, stare 8 let in starejše, je priporočeni odmerek 4 mg/ kg enkrat na dan, dva tedna, nato sledi odmerjanje 4 mg/ kg dvakrat na dan.
Calculation of the volume of Viramune® oral suspension (50 mg/ 5 ml) required for paediatric dosing after the two weeks lead-in period.
Izračun volumna peroralne suspenzije VIRAMUNE (50 mg/ 5 ml), potrebnega za odmerjanje pri otrocih po dvotedenskem uvajalnem obdobju:
Weight Range (kg) for Weight Range (kg) for
Razpon telesne mase (kg) Razpon telesne mase (kg)
patients < 8 yrs of age on a body weight basis receiving 7 mg/ kg.
mase odmerke po 7 mg/ kg
patients ≥ 8 years of age on a body weight basis receiving 4 mg/ kg.
mase odmerke po 4 mg/ kg
1.79 – 5.36 5.36 – 8.93 8.93 – 12.50 12.50 – 16.07 16.07 – 19.64 19.64 – 23.21 23.21 – 26.79 26.79+
12, 50 – 16, 07
3.13 – 9.38 9.38 – 15.63 15.63 – 21.88 21.88 – 28.12 28.12 – 34.37 34.37 – 40.62 40.62– 46.88 46.88+
21, 88 – 28, 12
2.5 5 7.5 10 12.5 15 17.5 20
10
All patients less than 16 years of age receiving VIRAMUNE oral suspension should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
Vsem bolnikom, mlajšim od 16 let, ki prejemajo peroralno suspenzijo VIRAMUNE, je treba pogosto preverjati telesno maso ali telesno površino, da bi ugotovili, ali je treba odmerek ponovno prilagoditi.
The recommended dose for VIRAMUNE is 20 ml (200 mg) oral suspension once 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 20 ml (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents.
Priporočeni odmerek VIRAMUNA je 20 ml (200 mg) peroralne suspenzije 1- krat na dan prvih 14 dni (tako uvajalno obdobje je treba upoštevati, ker so ugotovili, da zmanjša pogostnost izpuščaja), nato 20 ml (200 mg) peroralne suspenzije 2- krat na dan, v kombinaciji z najmanj dvema dodatnima protivirusnima zdraviloma.
It is important that the entire measured dose of VIRAMUNE oral suspension is administered.
Pomembno je, da vzame bolnik vso odmerjeno količino peroralne suspenzije VIRAMUNE.
If an alternative measuring device is used (e. g. a dispensing cup or teaspoon for larger doses) it is important that the device is rinsed to ensure complete removal of residual oral suspension.
Če uporabimo drugačen pripomoček za odmerjanje (npr. merilno posodico ali malo žlico za večje odmerke), ga moramo splakniti, da bi uporabili vso preostalo peroralno suspenzijo.
24 particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m2.
VIRAMUNE je na voljo tudi v tabletah po 200 mg za bolnike, stare 16 let in starejše, ali za starejše otroke, zlasti mladostnike, s telesno maso 50 kg ali več ali telesno površino nad 1, 25 m2.
VIRAMUNE may be taken with or without food.
23 VIRAMUNE lahko bolniki jemljejo s hrano ali brez.
Renal impairment For patients with renal dysfunction requiring dialysis an additional 200 mg dose of VIRAMUNE following each dialysis treatment is recommended.
Ledvična okvara Pri bolnikih z ledvično disfunkcijo, ki se zdravijo z dializo, priporočamo dodaten odmerek VIRAMUNA po 200 mg po vsaki dializi.
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).
Bolnikom z blago do zmerno jetrno okvaro odmerka ni potrebno prilagajati (glejte poglavji 4. 4 in 5. 2).
Patients experiencing rash during the 14-day lead-in period of 200 mg/ day (4 mg/ kg/ day or 150 mg/ m2/ day for paediatric patients) 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 (4 mg/ kg na dan ali 150 mg/ m2 na dan pri otrocih) pojavi izpuščaj, odmerka VIRAMUNA ne smemo povečati, dokler izpuščaj ne mine.
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 nadaljevati 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 zdravlejnje z VIRAMUNOM prekiniti, so navedeni v poglavju 4. 4.
25 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.
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.
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily (4 mg/ kg or 150 mg/ m2 for paediatric patients) 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 (4 mg/ kg ali 150 mg/ m2 pri otrocih) 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.
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
Therefore, patients should be monitored carefully for the appearance of rash during this period.
25 po začetku zdravljenja.
Patients should be instructed that dose escalation is not to occur if any rash occurs
Da bi ga odkrili, moramo v tem obdobju bolnike skrbno opazovati.
26 during the two-week lead-in dosing period, until the rash resolves.
Povedati jim moramo, da odmerka ne smemo povečati, če se med dvotedenskim uvajalnim obdobjem pojavi kakršenkoli izpuščaj, vse dokler le- ta ne mine.
Patients should be informed that hepatic reactions are a major toxicity of VIRAMUNE requiring a close monitoring during the first 18 weeks.
Bolnikom je treba povedati, da so jetrne reakcije pomemben toksični pojav ob VIRAMUNU, zaradi katerega je prvih 18 tednov treba skrbno spremljati zdravljenje.
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating VIRAMUNE therapy and at appropriate intervals during therapy.
Klinične kemijske preglede, ki zajemajo jetrne preiskave, je treba opraviti pred začetkom zdravljenja z VIRAMUNOM in v ustreznih razmikih med zdravljenjem.
Abnormal liver function tests have been reported with VIRAMUNE, some in the first few weeks of therapy.
26 Za VIRAMUNE poročajo o nenormalnih izvidih preiskav jetrne funkcije, o nekaterih v prvih tednih zdravljenja.
Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a
Pogosto opisujejo nesimptomatično povečanje jetrnih encimov, ki pa ni vedno kontraindikacija za VIRAMUNE.
VIRAMUNE must not be administered to patients with pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN (see section 4.3).
VIRAMUNA ne smemo dajati bolnikom, ki imajo pred zdravljenjem raven ASAT ali ALAT > 5- kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven ASAT/ ALAT ne stabilizira na < 5- kratno zgornjo mejno vrednost (glej poglavje 4. 3).
Pharmacokinetic results suggest caution should be exercised when VIRAMUNE is administered to patients with moderate hepatic dysfunction (Child-Pugh B).
Farmakokinetični podatki kažejo, da moramo biti previdni, kadar dajemo VIRAMUNE bolnikom z zmerno jetrno disfunkcijo (Child- Pugh C).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Bolnike s kroničnim hepatitisom B ali C, ki prejemajo kombinirano protivirusno zdravljenje, spremlja povečano tveganje hudih neželenih učinkov na jetra, ki so lahko tudi smrtno nevarni.
Other warnings
Druga opozorila:
Serious hepatotoxicity, including liver failure requiring transplantation, has been reported in HIV-uninfected individuals receiving multiple doses of VIRAMUNE in the setting of post-exposure-prophylaxis (PEP), an unapproved use.
Profilaksa po izpostavljenosti okužbi: pri posameznih osebah, ki sicer niso bile okužene s HIV, a so prejele več odmerkov VIRAMUNA v sklopu profilakse po izpostavljenosti okužbi, kar sicer ni odobrena uporaba, so poročali o resnih toksičnih učinkih na jetra, tudi o jetrni odpovedi, zaradi katere
Combination therapy with VIRAMUNE is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Kombinirano zdravljenje z VIRAMUNOM ni kurativna oblika zdravljenja s HIV- 1 okuženih bolnikov; še nadalje lahko zbolevajo za boleznimi, povezanimi z napredovano okužbo s HIV- 1, tudi oportunističnimi okužbami.
28 Combination therapy with VIRAMUNE has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or contaminated blood.
Za zdaj ni dokazano, da bi kombinirano zdravljenje z VIRAMUNOM zmanjšalo tveganje prenosa HIV- 1 na druge osebe med spolnim občevanjem ali z okuženo krvjo.
For this reason, and to reduce the risk of HIV transmission, barrier contraception (e. g. condoms) is recommended.
Iz tega razloga in zato, da bi zmanjšali nevarnost prenosa HIV, priporočamo uporabo mehanske kontracepcije (npr. kondoma).
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV infected patients.
Kombinirano protiretrovirusno zdravljenje povezujejo pri bolnikih, okuženih s HIV, s prerazporeditvijo telesnega maščevja (lipodistrofijo).
The long-term consequences of these events are currently unknown.
Dolgoročne posledice tega pojava še niso znane.
Knowledge about the mechanism is incomplete.
Poznavanje njegovega mehanizma je nepopolno.
The available pharmacokinetic data suggest that the concomitant use of rifampicin and VIRAMUNE is not recommended (please also refer to section 4.5).
Farmakokinetični podatki kažejo, da sočasna uporaba rifampicina in VIRAMUNA ni priporočljiva (glejte tudi poglavje 4. 5).
VIRAMUNE oral suspension contains 150 mg of sucrose per ml.
Peroralna suspenzija VIRAMUNE vsebuje 150 mg saharoze v mililitru.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redkim, dednim neprenašanjem fruktoze, malabsorpcijo glukoze- galaktoze ali pomanjkanjem saharoze - izomaltaze zdravila ne smejo jemati.
VIRAMUNE oral suspension contains 162 mg of sorbitol per ml.
Peroralna suspenzija VIRAMUNE vsebuje 162 mg sorbitola v mililitru.
Methyl and propyl parahydroxybenzoates:
Metil - in propilparahidroksibenzoat:
VIRAMUNE oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Peroralna suspenzija VIRAMUNE vsebuje metilparahidroksibenzoat in propilparahidroksibenzoat, ki lahko povzročita alergijsko reakcijo (ki je lahko zapoznela).
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij 28 Nevirapin je induktor CYP3A in lahko tudi CYP2B6.
29 metabolised medicinal products is recommended when taken in combination with VIRAMUNE.
Priporočamo skrbno spremljanje terapevtskega učinka zdravil, ki se presnavljajo prek P450, kadar jih bolnik jemlje v kombinaciji z VIRAMUNOM.