natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was the level of HIV in the blood (viral load) in the first 48 weeks of treatment.
Glavno merilo učinkovitosti je bila raven HIV v krvi (virusno breme) v prvih 48 tednih zdravljenja.
The effectiveness of Telzir, in combination with other antiviral medicines, has also been assessed in one main study including 57 HIV-infected children aged between two and 18 years.
Učinkovitost zdravila Telzir v kombinaciji z drugimi protivirusnimi zdravili je bila ocenjena tudi v eni glavni študiji, v katero je bilo vključenih 57 otrok, okuženih s HIV, starih od dveh do 18 let.
In the studies of treatment-naïve adults, ritonavir-boosted Telzir was as effective as the comparator medicines, but it was less effective in treatment-experienced adults.
V študijah pri odraslih, ki se še niso zdravili, je bilo z ritonavirjem ojačano zdravilo Telzir enako učinkovito kot primerjalna zdravila, vendar je bilo pri odraslih, ki so se zaradi okužbe s HIV že zdravili, manj učinkovito.
After 48 weeks, 69% of the treatment-naïve adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 322) had viral loads below 400 copies/ ml.
Po 48 tednih je imelo 69% bolnikov, ki se zaradi okužbe s HIV še niso zdravili in so jemali z ritonavirjem ojačano zdravilo Telzir (221 od 322), in 68% bolnikov, ki so jemali nelfinavir (221 od 327) virusno obremenitev pod 400 kopij/ ml.
Similar results were seen in the study comparing Telzir with lopinavir, with around three-quarters of both groups of patients having viral loads below 400 copies/ ml.
Podobne rezultate so opazili tudi v študiji, v kateri so primerjali zdravilo Telzir z lopinavirjem, kjer so imele približno tri četrtine obeh skupin bolnikov virusno breme pod 400 kopij/ ml.
In the study of treatment-experienced patients, the patients taking lopinavir had larger reductions in viral loads over the first 48 weeks.
V študiji z bolniki, ki so se zaradi okužbe s HIV že zdravili, so v prvih 48 tednih opazili večja zmanjšanja virusnega bremena pri bolnikih, ki so jemali lopinavir.
A similar benefit has also been seen in children receiving Telzir.
Podobno učinkovitost so opazili tudi pri otrocih, ki so prejemali zdravilo Telzir.
However, there were too few children aged below six years to support the use of Telzir in this age group.
Vendar pa je bilo število otrok, mlajših od šest let, premajhno, da bi podatki teh študij podprli uporabo zdravila Telzir v tej starostni skupini.
The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of triglycerides (a type of fat) in the blood.
Najpogostejša neželena učinka pri jemanju zdravila Telzir pri odraslih (opažena pri več kot 1 bolniku od 10) sta driska in povišana raven trigliceridov (vrsta maščob) v krvi.
Similar side effects are seen in children.
Pri otrocih so opaženi podobni neželeni učinki.
For the full list of all side effects reported with Telzir, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Telzir, glejte navodilo za uporabo.
Telzir must not be used in patients who are taking rifampicin (used to treat tuberculosis), St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Telzir or ritonavir and are harmful at high levels in the blood.
Zdravilo Telzir se prav tako ne sme uporabljati pri bolnikih, ki jemljejo rifampicin (zdravilo za zdravljenje tuberkuloze), šentjanževko (rastlinski pripravek za zdravljenje depresije) ali zdravila, ki se presnavljajo na enak način kot zdravilo Telzir ali ritonavir in katerih visoke ravni v krvi so škodljive.
Caution is also needed by patients taking Telzir at the same time as other medicines.
Previdnost je potrebna tudi pri bolnikih, ki zdravilo Telzir jemljejo sočasno z drugimi zdravili.
Why has Telzir been approved?
2/ 3 Zakaj je bilo zdravilo Telzir odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da ima zdravilo Telzir, ki vsebuje predzdravilo amprenavir, za bolnike prednost pred zdravilom Agenerase, saj morajo za enak odmerek amprenavirja, ki bi ga prejeli s kapsulami zdravila Agenerase, vzeti manjše število tablet zdravila Telzir.
The Committee decided that Telzir’ s benefits are greater than its risks for the treatment of HIV-1 infected adults and children of six years and above in combination with other antiretroviral medicinal products.
Odbor je zaključil, da so koristi zdravila Telzir v kombinaciji z drugimi protiretrovirusnimi zdravili pri zdravljenju odraslih in otrok, starih šest let ali več, okuženih s HIV- 1, večje od z njim povezanih tveganj.
The Committee noted that, in adults with moderate levels of exposure to antiviral medicines for the treatment of HIV infection, ritonavir-boosted Telzir has not 2/ 3 been shown to be as effective as ritonavir-boosted lopinavir.
Odbor je ugotovil, da z ritonavirjem ojačano zdravilo Telzir pri odraslih z zmerno stopnjo izpostavljenosti protivirusnim zdravilom ni bilo tako učinkovito pri zdravljenju okužbe z virusom HIV kot z ritonavirjem ojačani lopinavir.
In heavily pretreated patients, the use of ritonavir-boosted Telzir has not been studied sufficiently.
Pri bolnikih, ki so že prestali številna zdravljenja, uporabe z ritonavirjem ojačanega zdravila Telzir niso raziskali v zadostni meri.
In addition, no comparative studies have been carried out in children.
Prav tako ni bila izvedena nobena primerjalna študija pri otrocih.
The Committee recommended that Telzir be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Telzir.
The European Commission granted a marketing authorisation valid throughout the EU for Telzir to Glaxo Group Ltd on 12 July 2004.
Evropska komisija je dovoljenje za promet z zdravilom Telzir, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd dne 12. julija 2004.
Telzir 700 mg film-coated tablets.
Telzir 700 mg filmsko obložene tablete
Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
Zdravilo Telzir je v kombinaciji z nizkim odmerkom ritonavirja in v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starejših od 6 let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1).
In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir.
Pri odraslih bolnikih, ki so bili predhodno zmerno zdravljeni s protiretrovirusnimi zdravili, ni bilo dokazano, da bi bilo zdravilo Telzir v kombinaciji z nizkim odmerkom ritonavirja tako učinkovito kot kombinacija lopinavir/ ritonavir.
In protease inhibitor (PI) experienced patients the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1).
Pri bolnikih, ki so predhodno že bili zdravljeni z zaviralcem proteaz (PI), mora izbira zdravila Telzir temeljiti na individualnem testiranju virusne rezistence in podatkih predhodnega zdravljenja bolnikov (glejte poglavje 5. 1).
Telzir (fosamprenavir) is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir.
Zdravilo Telzir (fosamprenavir) je predzdravilo amprenavirja in se ne sme dajati sočasno z drugimi zdravili, ki vsebujejo amprenavir.
2 Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4).
2 V primeru prekoračitve spodaj navedenih priporočenih odmerkov zdravila Telzir v kombinaciji z ritonavirjem je potrebna previdnost (glejte poglavje 4. 4).
The adult dose of Telzir tablet 700 mg twice daily with ritonavir 100 mg twice daily may be used in children weighing at least 39 kg and able to swallow tablets.
700 mg zdravila Telzir v tabletah dvakrat na dan in 100 mg ritonavirja dvakrat na dan.
Telzir with ritonavir is not recommended in children below 6 years due to insufficient data on pharmacokinetics, safety and antiviral response (see section 5.2).
Otroci, mlajši od 6 let: zdravilo Telzir v kombinaciji z ritonavirjem zaradi pomanjkljivih podatkov o farmakokinetiki, varnosti in in protivirusnemu odzivu ni priporočljiv za otroke, mlajše od 6 let (glejte poglavje 5. 2).
The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
Farmakokinetične lastnosti fosamprenavirja pri takšni populaciji bolnikov niso bile raziskane (glejte poglavje 5. 2).
Renal impairment
Oslabljeno delovanje ledvic
No initial dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Smatra se, da pri bolnikih z oslabljenim delovanjem ledvic začetnega odmerka ni potrebno prilagoditi (glejte poglavje 5. 2).
For adults with mild hepatic impairment (Child-Pugh score:
Priporočeni odmerek za odrasle z blago jetrno okvaro (ocena po Child- Pugh- u:
5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
5- 6) je 700 mg fosamprenavirja dvakrat na dan v kombinaciji z ritonavirjem v odmerku 100 mg enkrat na dan.
For adults with moderate hepatic impairment (Child-Pugh score:
Priporočeni odmerek za odrasle z zmerno jetrno okvaro (ocena po Child- Pugh- u:
7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
7- 9) je 450 mg fosamprenavirja dvakrat na dan v kombinaciji z ritonavirjem v odmerku 100 mg enkrat na dan.
For adults with severe hepatic impairment (Child-Pugh score:
Pri odraslih s hudo jetrno okvaro (ocena po Child- Pugh- u:
10-15): fosamprenavir should be used with caution and at a reduced dose of 300 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
10- 15): fosamprenavir je potrebno uporabljati previdno in v manjšem odmerku 300mg fosamprenavirja dvakrat na dan s 100 mg ritonavirja enkrat na dan.
Even with these dose adjustments for adults, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore a close monitoring of safety and virologic response is warranted.
Zaradi večje variabilnosti med bolniki so kljub takšni prilagoditvi odmerka pri nekaterih bolnikih z jetrno okvaro lahko dosežene višje ali nižje plazemske koncentracije amprenavirja in/ ali ritonavirja od pričakovanih, v primerjavi z bolniki, ki imajo normalno jetrno funkcijo, (glejte poglavje 5. 2), zato je treba te bolnike skrbno nadzirati glede varnosti in virološkega odziva.
3 No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
4. 3 Kontraindikacije
Hypersensitivity to fosamprenavir, amprenavir or to any of the excipients of Telzir, or to ritonavir.
Preobčutljivost za fosamprenavir, amprenavir, katero koli pomožno snov zdravila Telzir ali ritonavir.
Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e. g. amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam.
Zdravilo Telzir se ne sme uporabljati sočasno z zdravili ozke terapevtske širine, ki so substrat za citokrom P450 3A4 (CYP3A4), npr. z amiodaronom, astemizolom, bepridilom, s cisapridom, z dihidroergotaminom, ergotaminom, pimozidom, s kinidinom, terfenadinom, peroralno obliko midazolama (glede previdnostnih ukrepov ob parenteralni uporabi midazolama glejte poglavje 4. 5), peroralno obliko triazolama.
Telzir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e. g. flecainide and propafenone (see section 4.5).
Zdravilo Telzir v kombinaciji z ritonavirjem se ne sme uporabljati sočasno z zdravili ozke terapevtske širine, ki so pri svoji presnovi zelo odvisni od CYP2D6, npr. s flekainidom in propafenonom (glejte poglavje 4. 5).
(see section 4.5).
Kombinacija rifampicina in zdravila Telzir skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte poglavje 4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Pripravki rastlinskega izvora s šentjanževko (Hypericum perforatum) se zaradi nevarnosti znižanja plazemskih koncentracij in manjše klinične učinkovitosti amprenavirja ne smejo uporabljati sočasno z zdravilom Telzir (glejte poglavje 4. 5).
Current antiretroviral therapies, including Telzir, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Ni dokazov, da bi trenutno razpoložljiva protiretrovirusna zdravljenja, vključno z zdravilom Telzir, lahko preprečila prenos virusa HIV med spolnim stikom ali z okuženo krvjo.
Appropriate precautions should continue to be taken.
Bolniki morajo še naprej skrbeti za ustrezne varnostne ukrepe.
Telzir with ritonavir should be used with caution and at reduced doses in adults with mild, moderate, or severe hepatic impairment (see section 4.2. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Pri odraslih z blago, zmerno ali hudo jetrno okvaro je treba zdravilo Telzir v kombinaciji z ritonavirjem uporabljati previdno in odmerke zmanjšati (glejte poglavje 4. 2).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be
Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s kombiniranim protiretrovirusnim zdravljenjem, obstaja veliko tveganje za pojav hudih in potencialno usodnih neželenih učinkov, povezanih z jetri.
4 monitored according to standard practice.
4 Med kombiniranim protiretrovirusnim zdravljenjem so se pri bolnikih z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, pogosteje pojavljale nepravilnosti v jetrnem delovanju in jih je bilo potrebno nadzirati po splošno uveljavljenih načelih.
The use of Telzir concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Zdravila Telzir ni priporočljivo uporabljati sočasno s halofantrinom ali z lidokainom (sistemskim) (glejte poglavje 4. 5).
The use of Telzir concomitantly with PDE5 inhibitors (e. g. sildenafil and vardenafil) is not recommended (see section 4.5).
Zdravila Telzir ni priporočljivo uporabljati sočasno z zaviralci fosfodiesteraze tipa 5 (PDE5) (npr. s sildenafilom in z vardenafilom) (glejte poglavje 4. 5).
Concomitant use of Telzir with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis (see section 4.5).
Zaradi večjega tveganja za miopatije vključno z rabdomiolizo zdravila Telzir ni priporočljivo uporabljati sočasno s simvastatinom ali z lovastatinom (glejte poglavje 4. 5).
A reduction in the rifabutin dosage by at least 75% is recommended when administered with Telzir with ritonavir.
Pri sočasnem dajanju rifabutina ter zdravila Telzir v kombinaciji z ritonavirjem je priporočljivo, da se odmerek rifabutina zmanjša vsaj za 75%.
Further dose reduction may be necessary (see section 4.5).
Odmerek pa bo morda potrebno še dodatno zmanjšati (glejte poglavje 4. 5).
Because there may be an increased risk of hepatic transaminase elevations and hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative non- hormonal methods of contraception are recommended for women of childbearing potential (see section 4.5).
Pri sočasni uporabi fosamprenavirja, ritonavirja in peroralnih kontraceptivov obstaja večje tveganje za povišanje jetrnih transaminaz in spremembo vrednosti hormonov, zato je pri ženskah v rodni dobi priporočljiva uporaba alternativnih nehormonskih kontracepcijskih metod (glejte poglavje 4. 5).
No data are available on the co-administration of fosamprenavir and ritonavir with oestrogens and/ or progestogens when used as hormonal replacement therapies.
Podatki o sočasni uporabi fosamprenavirja in ritonavirja ter estrogenov in/ ali progestogenov v sklopu hormonskega nadomestnega zdravljenja niso na voljo.
Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Pri bolnikih, ki sočasno jemljejo omenjena zdravila, je zaradi manjših plazemskih koncentracij amprenavirja, učinkovitost zdravila Telzir lahko manjša (glejte poglavje 4. 5).
Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Telzir (see section 4.5).
Če se zdravila za zaviranje imunske odzivnosti (ciklosporin, takrolimus, rapamicin) dajejo sočasno z zdravilom Telzir, je priporočljivo nadzirati njihove terapevtske koncentracije (glejte poglavje 4. 5).
Therapeutic concentration monitoring is recommended for tricyclic antidepressants (e. g. desipramine and nortriptyline) when coadministered with Telzir (see section 4.5).
Če se triciklični antidepresivi (npr. dezipramin in nortriptilin) dajejo sočasno z zdravilom Telzir, je priporočljivo nadzirati njihove terapevtske koncentracije (glejte poglavje 4. 5).
When warfarin or other oral anticoagulants are coadministered with Telzir a reinforced monitoring of INR (International Normalised Ratio) is recommended (see section 4.5).
Če se varfarin ali drugi peroralni antitrombotiki dajejo sočasno z zdravilom Telzir, je priporočljivo poostreno nadzirati INR (internacionalno normalizirano razmerje) (glejte poglavje 4. 5).
Concomitant use of Telzir with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing’ s syndrome and adrenal suppression (see section 4.5).
Sočasne uporabe zdravila Telzir v kombinaciji z ritonavirjem in flutikazonom ali drugimi glukokortikoidi, ki se presnavljajo s CYP3A4, ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4. 5).
Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
O hudih in smrtno nevarnih kožnih reakcijah, vključno s Stevens- Johnsonovim sindromom, so poročali pri manj kot 1% bolnikov, ki so bili vključeni v klinični razvojni program.
Telzir should be permanently discontinued in case of severe rash, or in case of rash of moderate intensity with systemic or mucosal symptoms (see section 4.8).
V primeru hudega eksantema ali v primeru eksantema zmerne intenzitete, ki ga spremljajo sistemski simptomi ali simptomi s strani sluznic, je potrebno uporabo zdravila Telzir trajno ukiniti (glejte poglavje 4. 8).
In some
Hemofiliki
5 patients administration of factor VIII was necessary.
5 Pri bolnikih s hemofilijo tipa A in B, ki so se zdravili z zaviralci proteaz (PI), so poročali o pogostnejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Pri bolnikih, ki so prejemali protiretrovirusna zdravila, vključno zaviralce proteaz, so poročali o nastopu sladkorne bolezni, o hiperglikemiji ali poslabšanju obstoječe sladkorne bolezni.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Pri posameznikih je bila hiperglikemija huda in v nekaterih primerih tudi povezana s ketoacidozo.
Many of the patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with the development of diabetes mellitus or hyperglycaemia.
Mnogo bolnikov je imelo kompleksno zdravstveno stanje, nekateri od njih pa so potrebovali zdravljenje z zdravili, ki so sama po sebi povezana s pojavom sladkorne bolezni ali hiperglikemijo.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Pri bolnikih, okuženih z virusom HIV, je bilo kombinirano protiretrovirusno zdravljenje povezano s prerazporeditvijo telesnega maščevja (lipodistrofija).
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Domneva se, da gre za povezavo med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in zaviralci nukleotidne in nukleozidne reverzne transkriptaze.
Clinical examination should include evaluation for physical signs of fat redistribution.
Klinični pregled mora obsegati oceno telesnih znakov prerazporeditve maščevja.
4.5 Interaction with other medicinal products and other forms of interaction
6 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
6 metabolic pathway or modify CYP3A4 activity may modify the pharmacokinetics of amprenavir and ritonavir.
Tako lahko zdravila, ki bodisi z njima delijo to presnovno pot bodisi spremenijo aktivnost CYP3A4, spremenijo farmakokinetične lastnosti amprenavirja in ritonavirja.
• Associations contraindicated (see section 4.3)
• Povezave s kontraindikacijami (glejte poglavje 4. 3)
CYP3A4 substrates with narrow therapeutic index Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4).
Substrati za CYP3A4 z ozkim terapevtskim indeksom Zdravilo Telzir se ne sme uporabljati sočasno z zdravili ozke terapevtske širine, ki vsebujejo zdravilne učinkovine, ki so substrati za citokrom P450 3A4 (CYP3A4).
Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e. g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e. g. ergotamine, dihydroergotamine).
Sočasna uporaba ima lahko za posledico kompetitivno inhibicijo presnavljanja teh zdravilnih učinkovin in tako njihove večje plazemske vrednosti, kar izzove možnost resnih in/ ali smrtno nevarnih neželenih reakcij, kot so: aritmija (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin) ali periferni vazospazem ali ishemija (npr. ergotamin, dihidroergotamin).
CYP2D6 substrates with narrow therapeutic index Telzir with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
Substrati za CYP2D6 z ozkim terapevtskim indeksom Zdravilo Telzir v kombinaciji z ritonavirjem se ne sme uporabljati sočasno z zdravili, ki vsebujejo zdravilne učinkovine, ki so pri presnovi zelo odvisne od CYP2D6 in katerih povečane plazemske koncentracije so povezane z resnimi in/ ali smrtno nevarnimi neželenimi reakcijami.