natgillin/translations-raw huggingface dataset:
Since this product will pass into your milk and may adversely affect the breast-fed child, you should discontinue breast-feeding while taking Suboxone.
Ker to zdravilo prehaja v materino mleko in lahko škoduje dojenčku, morate med jemanjem zdravila Suboxone prenehati z dojenjem.
Driving and using machines Suboxone may cause drowsiness.
Vpliv na sposobnost upravljanja vozil in strojev Suboxone lahko povzroči zaspanost.
If you feel tired, do not drive a motor vehicle or operate machinery.
Če ste utrujeni, ne smete voziti motornega vozila ali upravljati s stroji.
Important information about some of the ingredients of Suboxone Suboxone contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Suboxone Suboxone vsebuje laktozo.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom
HOW TO TAKE SUBOXONE
KAKO JEMATI ZDRAVILO SUBOXONE
Sublingual route is the only efficacious administration route for this product.
Podjezična uporaba je edina učinkovita pot uporabe tega zdravila.
Do not swallow the tablets.
Tablete ne smete pogoltniti.
This may take 5-10 minutes.
Tableto držite pod jezikom, dokler se ne raztopi, kar lahko traja od 5 do 10 minut.
Take the dose once a day.
Odmerek vzemite enkrat na dan.
During your treatment, the doctor may adjust the dose, depending upon your response.
Med zdravljenjem vam bo zdravnik lahko prilagodil odmerek, odvisno od vašega odziva.
To get the greatest benefit from taking Suboxone, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that have not been prescribed to you by your doctor.
Da bi imeli kar največ koristi od jemanja zdravila Suboxone, morate svojemu zdravniku povedati za vsa zdravila, ki jih jemljete, vključno z alkoholom, zdravili, ki vsebujejo alkohol, drogami, ter za morebitna zdravila na recept, ki jih jemljete, a vam jih ni predpisal vaš zdravnik.
After the first dose of Suboxone, it is possible that you may have some opiate withdrawal symptoms, see section 4 ‘ POSSIBLE SIDE EFFECTS’.
Po prvem odmerku zdravila Suboxone boste lahko imeli nekatere simptome odtegnitve opiatov, glejte poglavje 4 ‘ MOŽNI NEŽELENI UČINKI ’.
Treatment duration The length of treatment will be determined individually by your doctor.
Dolžina zdravljenja Dolžino zdravljenja bo individualno določil vaš zdravnik.
After a time of successful treatment, the doctor may reduce the dose gradually to a lower maintenance dose.
Po določenem času uspešnega zdravljenja vam bo zdravnik lahko postopoma zmanjšal odmerek na nižji vzdrževalni odmerek.
Depending on your condition, the Suboxone dose may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Odvisno od vašega stanja bo lahko še naprej zmanjševal odmerek zdravila Suboxone pod skrbnim medicinskim nadzorom, dokler ne bo zdravljenje dokončno ustavil.
Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
Zdravljenja ne smete kakorkoli spreminjati sami ali ga ustaviti brez soglasja svojega lečečega zdravnika.
The effectiveness of this treatment depends:
Učinkovitost tega načina zdravljenja je odvisna od:
- on the dose,
- odmerka,
- in combination with the associated medical, psychological and social treatment.
- ter pridružene medicinske, psihološke in socialne obravnave.
If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila Suboxone premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
If you use more Suboxone than you should In case of overdose of buprenorphine, you must go or be taken immediately to an emergency centre or hospital for treatment.
Če ste vzeli večji odmerek zdravila Suboxone, kot bi smeli V primeru prevelikega odmerjanja buprenorfina morate nemudoma iti oziroma vas morajo nemudoma odpeljati v center za nujno medicinsko pomoč ali v bolnišnico na zdravljenje.
Advise immediately your doctor or your pharmacist.
O tem morate takoj obvestiti svojega zdravnika ali farmacevta.
If you forget to use Suboxone
Če ste pozabili vzeti zdravilo Suboxone
39 Contact your doctor.
39 Pokličite svojega zdravnika.
If you stop using Suboxone Stopping treatment suddenly may cause withdrawal symptoms.
Če ste prenehali jemati zdravilo Suboxone Naglo prenehanje zdravljenja lahko povzroči odtegnitvene simptome.
Like all medicines, Suboxone can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Suboxone neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
After the first dose of Suboxone, you may have some opiate withdrawal symptoms, see section 3 ‘ HOW TO TAKE SUBOXONE’.
Po prvem odmerku zdravila Suboxone boste lahko imeli nekatere simptome odtegnitve opiatov, glejte poglavje 3 ‘ KAKO JEMATI ZDRAVILO SUBOXONE ’.
Very common side effects (occurring in at least 1 in 10 patients) that may occur with Suboxone are: insomnia, constipation, nausea, sweating, headache, withdrawal syndrome.
Zelo pogosti neželeni učinki (pojavljajo se pri najmanj 1 od 10 bolnikov), ki se lahko pojavijo pri zdravilu Suboxone, so nespečnost, zaprtje, slabost, potenje, glavobol, odtegnitveni sindrom.
Common side effects (occurring in at least 1 in 100 patients) that may occur during treatment with Suboxone are: weight loss, swelling (hands and feet), tiredness, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, muscle spasms, abnormal thinking, tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach, diarrhoea, abnormal liver function, loss of appetite, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps, impotence, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu syndrome, feeling of general discomfort, accidental injury, faintness and dizziness, drop in blood pressure on changing position from sitting or lying down to standing.
Pogosti neželeni učinki (ki se pojavljajo pri najmanj 1 od 100 bolnikov) med zdravljenjem z zdravilom Suboxone so: hujšanje, otekanje (roke in stopala), utrujenost, zaspanost, tesnoba, živčnost, mravljinci, depresija, zmanjšana spolna sla, mišični krči, nenormalno mišljenje, prekomerno solzenje, zamegljen vid, pordelost, zvišan krvni tlak, migrena, izcedek iz nosa, vneto žrelo in boleče požiranje, okrepljen kašelj, želodčne težave, driska, nenormalno delovanje jeter, izguba teka, napenjanje, bruhanje, izpuščaj, srbenje, koprivnica, bolečine, sklepne bolečine, mišične bolečine, krči v nogah, impotenca, nenormalen seč, trebušne bolečine, bolečine v hrbtu, oslabelost, okužbe, mrzlica, bolečine v prsih, zvišana telesna temperatura, gripozni sindrom, občutek splošnega neugodja, nezgodne poškodbe, omotičnost in padec krvnega tlaka ob spremembi položaja iz sedečega ali ležečega v stoječega.
Uncommon side effects (occurring in at least 1 in 1,000 patients) with Suboxone are: swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalization (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well being, convulsion (fits), speech disorder, small pupil size, problems with urination, conjunctivitis, rapid or slow heart beat, low blood pressure, palpitations, myocardial infarction (heart attack), shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, sensitivity to heat or cold, allergic reaction, feelings of hostility.
Občasni neželeni učinki (ki se pojavljajo pri najmanj 1 od 1. 000 bolnikov) zdravila Suboxone so: otekle limfne žleze (bezgavke), vznemirjenost, tresenje, nenormalne sanje, prekomerna mišična aktivnost, depersonalizacija (občutek da ste spremenjeni), odvisnost od zdravil, amnezija (motnje spomina), izguba zanimanja, pretiran občutek dobrega počutja, konvulzije (epileptični napadi), motnje govora, ozke zenice, težave z uriniranjem, vnetje očesne veznice, prehiter ali prepočasen pulz, nizek krvni tlak, razbijanje srca, miokardni infarkt (srčni napad), težko dihanje, astma, zehanje, bolečine in ranice v ustih, obarvanje jezika, akne, vozlički v koži, izpadanje las, suha ali luskasta koža, vnetje sklepov, okužbe sečil, kri v seču, nenormalna ejakulacija, menstrualne ali vaginalne težave, ledvični kamni, občutljivost na vročino ali mraz, alergijske reakcije in občutki sovražnosti.
Rarely (occurring in at least 1 in 10,000 patients), the following have occurred with buprenorphine alone:
- depresija dihanja (hude težave z dihanjem) – glejte poglavje “ Bodite posebno pozorni pri
- respiratory depression (severe difficulty in breathing) - see “ Take special care with Suboxone”,
jemanju zdravila Suboxone ”,
- liver problems with or without jaundice- see “ Take special care with Suboxone”,
Suboxone ”,
- hallucinations.
- halucinacije.
Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems - see “ Take special care with Suboxone”.
Zloraba tega zdravila z injiciranjem lahko povzroči odtegnitvene simptome, okužbe, druge kožne reakcije in potencialno resne jetrne težave – glejte poglavje “ Bodite posebno pozorni pri jemanju zdravila Suboxone ”.
HOW TO STORE SUBOXONE
40 Zdravilo shranjujte nedosegljivo otrokom!
Do not use Suboxone after the expiry date which is stated on the carton.
Zdravila Suboxone ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
- The active substance is buprenorphine and naloxone.
- Zdravilni učinkovini sta buprenorfin in nalokson.
Each tablet contains 2 mg buprenorphine
Vsaka tableta vsebuje 2 mg buprenorfina v
as buprenorphine hydrochloride and 0.5 mg naloxone as naloxone hydrochloride dihydrate.
obliki buprenorfinijevega klorida in 0, 5 mg naloksona v obliki naloksonijevega klorid dihidrata.
- The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric
- Pomožne snovi so laktoza monohidrat, manitol, koruzni škrob, povidon K30, brezvodna
acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
citronska kislina, natrijev citrat, magnezijev stearat, kalijev acesulfamat in naravni aromi limone in limete.
Sublingual tablets, white hexagonal biconvex tablets, embossed with a sword logo on one side and “ N2” on the reverse side, packed in packs of 7 and 28 tablets.
Podjezične tablete, bele heksagonalne, bikonveksne tablete z vtisnjenim znakom meča na eni strani in “ N2 ” na drugi strani, v pakiranjih po 7 in 28 tablet.
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, East Yorkshire HU8 7DS, United Kingdom.
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, East Yorkshire HU8 7DS, Velika Britanija.
41 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21019.1
Centro Direzionale Milano Due Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21019. 1
Suboxone 8 mg/ 2 mg sublingual tablets buprenorphine / naloxone
Suboxone 8 mg / 2 mg podjezične tablete buprenorfin/ nalokson
44 This product can cause withdrawal symptoms if you take it less than six hours after you use a narcotic (e. g. morphine, heroin) or less than 24 hours after you use methadone.
To zdravilo lahko povzroči odtegnitvene simptome, če ga vzamete manj kot šest ur po uporabi narkotika (npr. morfina, heroina) ali manj kot 24 ur po uporabi metadona.
45 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
45 Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
46 Contact your doctor.
46 Pokličite svojega zdravnika.
HOW TO STORE SUBOXONE
47 Zdravilo shranjujte nedosegljivo otrokom!
Each tablet contains 8 mg buprenorphine
Vsaka tableta vsebuje 8 mg buprenorfina v
as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate.
obliki buprenorfinijevega klorida in 2 mg naloksona v obliki naloksonijevega klorid dihidrata.
Sublingual tablets, white hexagonal biconvex tablets, embossed with a sword logo on one side and “ N8” on the reverse side, packed in packs of 7 and 28 tablets.
Podjezične tablete, bele heksagonalne, bikonveksne tablete z vtisnjenim znakom meča na eni strani in “ N8 ” na drugi strani, v pakiranjih po 7 in 28 tablet.
48 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, trda Kapsula, trda Kapsula, trda Kapsula, trda
bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (alu/ PVC)
plastenka (HDPE) plastenka (HDPE) plastenka (HDPE) pretisni omot (alu/ PVC)
30 capsules 30 capsules 90 capsules 42 capsules
30 kapsul 30 kapsul 90 kapsul 42 kapsul
Oral solution Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Peroralna raztopina Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
bottle (HDPE) bottle (HDPE) blister (alu) HDPE bottle blister (Alu) blister (alu/ PVC)
plastenka (HDPE) plastenka (HDPE) pretisni omot (alu) plastenka HDPE pretisni omot (alu) pretisni omot (alu/ PVC)
1 bottle + 1 syringe 60 tablets 60 tablets 30 tablets 30 tablets 90 tablets (3x30x1)
1 plastenka + 1 brizga 60 tablet 60 tablet 30 tablet 30 tablet 90 tablet (3x30x1)
Sustiva is a medicine that contains the active substance efavirenz.
Sustiva je zdravilo, ki vsebuje zdravilno učinkovino efavirenz.
200 mg), as yellow, capsule-shaped tablets (600 mg) and as an oral solution (30 mg/ ml).
200 mg), tabletah rumene barve v obliki kapsul (600 mg) ter v obliki peroralne raztopine (30 mg/ ml).
Sustiva is an antiviral medicine.
Zdravilo Sustiva je protivirusno zdravilo.
Treatment with Sustiva should be started by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Sustiva mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
It is recommended that Sustiva be taken on an empty stomach and without food, preferably at bedtime.
Priporočljivo je, da se zdravilo Sustiva jemlje na tešče, in sicer brez hrane, po možnosti pred spanjem.
The recommended dose of Sustiva for adults is 600 mg once a day.
Priporočeni odmerek zdravila Sustiva pri odraslih je 600 mg enkrat dnevno.
For patients who are unable to swallow the capsules or tablets, Sustiva can be given using the oral solution.
Pri bolnikih, ki kapsul ali tablet ne morejo pogoltniti, se zdravilo Sustiva lahko daje v obliki peroralne raztopine.
If the patient cannot tolerate the oral solution, mixing the contents of the capsules with a small amount of food (around two teaspoons) can be considered.
Če bolnik ne prenaša peroralne raztopine, lahko zdravilo zaužije tako, da zmeša vsebino kapsul z majhno količino hrane (približno dve čajni žlički).
The dose of Sustiva needs to be reduced in patients taking voriconazole (used to treat fungal infections).
Odmerek zdravila Sustiva je treba zmanjšati pri bolnikih, ki jemljejo vorikonazol (zdravilo za zdravljenje glivičnih okužb).
Patients taking rifampicin (an antibiotic) may need to take a higher dose of Sustiva.
Pri bolnikih, ki jemljejo rifampicin (antibiotik), pa bo morda treba odmerek zdravila Sustiva povečati.
By blocking this enzyme, Sustiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Sustiva, uporabljeno v kombinaciji z drugimi protivirusnimi zdravili, z blokiranjem tega encima zmanjša količino virusa HIV v krvi in ga ohranja na nizki ravni.
Sustiva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Sustiva ne ozdravi okužbe s HIV ali AIDS- a, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS- om.
Sustiva has been studied in three main studies involving over 1,100 adults:  in the first study, Sustiva in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine;  the second study compared Sustiva in combination with nelfinavir and two other antiviral medicines with the same combination without Sustiva;  the third study compared adding Sustiva or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Zdravilo Sustiva so proučevali v okviru treh glavnih študij, ki so vključevale več kot 1 100 odraslih:  v prvi študiji so zdravilo Sustiva v kombinaciji z lamivudinom in zidovudinom ali z indinavirjem (drugimi protivirusnimi zdravili) primerjali s kombinacijo indinavirja, lamivudina in zidovudina;  v drugi študiji so zdravilo Sustiva v kombinaciji z nelfinavirjem primerjali z dvema drugima protivirusnima zdraviloma v isti kombinaciji, a brez zdravila Sustiva;  v tretji študiji so pri bolnikih, ki so se že zdravili zaradi okužbe z virusom HIV, primerjali dodajanje zdravila Sustiva ali placeba (zdravila brez zdravilne učinkovine) kombinaciji protivirusnih zdravil, ki so vključevala indinavir in dve drugi protivirusni zdravili.
Sustiva has also been studied in 57 children aged between three and 16 years, in combination with nelfinavir and other antiviral medicines.
Zdravilo Sustiva so v kombinaciji z nelfinavirjem in drugimi protivirusnimi zdravili proučevali tudi pri 57 otrocih, starih od tri do 16 let.
All of the studies showed that combinations including Sustiva were at least as effective as the comparator medicines:  the first study showed that 67% of the adults treated with Sustiva in combination with zidovudine and lamivudine had viral loads below 400 copies/ ml after 48 weeks, compared with 54% of the patients treated with Sustiva and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;  in the second study, Sustiva in combination with nelfinavir was superior to the combination without Sustiva:
Vse študije so pokazale, da so bile kombinacije z zdravilom Sustiva vsaj tako učinkovite kot primerjalna zdravila:  prva študija pokazala, da je imelo 67% odraslih, zdravljenih z zdravilom Sustiva v kombinaciji z zidovudinom in lamivudinom, po 48 tednih virusno breme pod 400 kopij/ ml, v primerjavi s 54% bolnikov, zdravljenih z zdravilom Sustiva in indinavirjem, ter 45% bolnikov, zdravljenih z indinavirjem, lamivudinom in zidovudinom;  v drugi študiji je bilo zdravilo Sustiva v kombinaciji z nelfinavirjem učinkovitejše od kombinacije brez zdravila Sustiva:
70% and 30% of the patients, respectively, had viral loads below 500 copies/ ml after 48 weeks;  the third study showed that more patients receiving Sustiva had viral loads below 400 copies/ ml than those taking placebo after 24 weeks.
70% oziroma 30% bolnikov je imelo po 48 tednih zdravljenja virusna bremena pod 500 kopij/ ml;  tretja študija je po 24 tednih pokazala, da je bilo virusno breme pod 400 kopij/ ml pogostejše pri bolnikih, zdravljenih z zdravilom Sustiva, kot pri tistih, ki so prejemali placebo.
The most common side effect with Sustiva (seen in more than 1 patient in 10) is rash.
Najpogostejši neželen učinek zdravila Sustiva (opažen pri več kot 1 bolniku od 10) so izpuščaji.
Sustiva is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Zdravilo Sustiva je povezano tudi s simptomi živčnega sistema, kot so omotica, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje, ter s psihiatričnimi motnjami, kot so huda depresija, samomorilno razmišljanje, poskusi samomora in agresivno obnašanje, zlasti pri bolnikih, ki so v preteklosti že imeli duševne motnje.
Taking Sustiva with food may lead to an increase in the frequency of side effects.
Jemanje zdravila Sustiva s hrano lahko vodi do povečanja pogostosti neželenih učinkov.
For a more complete list of side effects reported with Sustiva, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sustiva, glejte navodilo za uporabo.
Sustiva should not be used in patients who may be hypersensitive (allergic) to efavirenz or any of the other ingredients.
Zdravila Sustiva ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) efavirenz ali katero koli drugo sestavino zdravila.
As with other anti-HIV medicines, patients taking Sustiva 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 Sustiva, nevarnost lipodistrofije (sprememb v porazdelitvi telesnega maščevja), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem, medtem ko se zdravi).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Sustiva.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravila Sustiva povečano tveganje za poškodbe jeter.
2/ 3 Why has Sustiva been approved?
2/ 3 Zakaj je bilo zdravilo Sustiva odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sustiva’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three years of age and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Sustiva pri protivirusnem kombiniranem zdravljenju odraslih, mladostnikov in otrok, starih tri leta ali več, okuženih z virusom HIV, večje od z njim povezanih tveganj.
The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Odbor je ugotovil, da zdravilo Sustiva ni bilo ustrezno raziskano pri bolnikih z napredovalo boleznijo (število celic CD4 pod 50 celic/ mm3) ali po zdravljenju z zaviralci proteaze (drugo vrsto protivirusnega zdravila), ki ni bilo uspešno.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Sustiva in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Odbor je poleg tega ugotovil, da obstaja malo informacij o koristih zdravljenja z zaviralci proteaze pri bolnikih, ki so bili v preteklosti zdravljeni z zdravilom Sustiva, ki je čez čas postalo neučinkovito, čeprav ni dokazov, da zaviralci proteaze pri teh bolnikih ne bi bili učinkoviti.