FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 v kombinaciji s cisplatinom in 5-fluorouracilom pri raku glave in vratu
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE uporabljajte drugih zdravil, ki vsebujejo docetaksel in so sestavljena iz dveh vial (koncentrata in vehikla), skupaj s tem zdravilom (Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Adjusted hazard ratio (95% CI) *p-value
Slovenian: Popravljeno razmerje tveganja (95 % IZ) *p-vrednost
English: Eye disorders Respiratory, thoracic and mediastinal disorders
Slovenian: Očesne bolezni zvečano solzenje, konjunktivitis
English: - The active substance is docetaxel (as trihydrate).
Slovenian: Kaj vsebuje zdravilo Taxespira - Učinkovinaje docetaksel (v obliki trihidrata).
English: Lacrimation increased (G3/4: 0%)
Slovenian: eksfoliacija kože (S3/4: 0 %)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE uporabljajte drugih zdravil, ki vsebujejo docetaksel in so sestavljena iz dveh vial (koncentrata in vehikla), skupaj s tem zdravilom (Taxespira 120 mg/6 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Hypotension (G3/4:
Slovenian: Žilne bolezni hipotenzija (S3/4:
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE uporabljajte drugih zdravil, ki vsebujejo docetaksel in so sestavljena iz dveh vial (koncentrata in vehikla), skupaj s tem zdravilom (Taxespira 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: 95% CI p-value*
Slovenian: 95 % IZ p = razmerje tveganj*
English: Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo Taxespira v monoterapiji je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 pri raku dojke v kombinaciji s kapecitabinom
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Slovenian: Preiskave zvečanje bilirubina v krvi S3/4 (< 5 %), zvečanje alkalne fosfataze v krvi S3/4 (<
English: Arrhythmia (G3/4:
Slovenian: pruritični izpuščaj (S3/4:
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 v kombinaciji s cisplatinom in 5-fluorouracilom pri adenokarcinomu želodca
English: Dyspnoea (severe:
Slovenian: spremembe nohtov (hude:
English: General disorders and administration site conditions Investigations
Slovenian: Splošne težave in spremembe na mestu aplikacije letargija
English: • fever or chills
Slovenian: • zvišana telesna temperatura ali mrzlica
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
English: Tumour response rate (%) 95% CI p-value*
Slovenian: p-vrednost število bolnikov odzivnost na PSA** (%) 95 % IZ p-vrednost*
English: Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Slovenian: Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (S3/4: 1 %), kašelj (S3/4:
English: Taxespira 20 mg/1 ml concentrate for solution for infusion.
Slovenian: Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel i.v.
English: Psychiatric disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje anoreksija Psihiatrične motnje
English: associated with alkaline phosphatase >2.5 × ULN, and bilirubin >1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 × ULN ter hkrati alkalno fosfatazo > 2,5 × ULN in bilirubinom > 1 × ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
English: Taxespira in combination with trastuzumab
Slovenian: Zdravilo Taxespira v kombinaciji s trastuzumabom
English: Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Slovenian: zaprtje, ezofagitis/disfagija/odin ofagija (S3/4: 0,6 %), bolečine v trebuhu, dispepsija, krvavitev v prebavilih (S3/4: 0,6 %)
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Slovenian: Presnovne in prehranske motnje anoreksija(S3/4: 11,7 %) Bolezni živčevja omotica (S3/4: 2,3 %), periferna motorična nevropatija (S3/4: 1,3 %)
English: Skin reaction (G3/4:
Slovenian: spremembe nohtov (S3/4:
English: Epistaxis (G3/4: 0%);
Slovenian: somnolenca (S3/4; 0 %)
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Slovenian: Infekcijskein parazitske bolezni okužba (S3/4: 3,3 %) Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Slovenian: Očesne bolezni močnejše solzenje (S3/4: 0,6 %)
English: Hazard ratio: (95% CI) **p-value
Slovenian: Razmerje ogroženosti: (95 % IZ) **Vrednost p
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje Bolezni živčevja vrtoglavost
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Slovenian: Presnovne in prehranske motnje anoreksija Bolezni živčevja periferna senzorična nevropatija (S3/4: 0,8 %)
English: Nail disorders (severe: 0.8%)
Slovenian: spremembe nohtov (hude 2,6 %)
English: Venous disorder (G3/4:
Slovenian: Žilne bolezni venska bolezen (S3/4:
English: Hypersensitivity (G3/4: 0.6%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S3/4: 0,6 %)
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Slovenian: Opis izbranih neželenih učinkov monoterapije z zdravilom Taxespira100 mg/m 2 pri raku dojke
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Slovenian: Presnovne in prehranske motnje anoreksija(S3/4: 0,6 %) Bolezni živčevja periferna senzorična nevropatija (S3/4: 1,2 %), disgevzija (S3/4: 0 %)
English: Dermatitis; Rash erythematous (G3/4: <1%); Nail discolouration;
Slovenian: Bolezni kože in podkožja dermatitis, eritematozen izpuščaj (S3/4: < 1 %), obarvanje nohtov, oniholiza (S3/4: 1 %)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom Taxespira 75 mg/m 2 pri nedrobnoceličnem pljučnem raku
English: In some cases (frequency not known)
Slovenian: V nekaterih primerih (neznana pogostnost) pa se pojavi trajna izguba las in dlak
English: Alopecia (persisting: <3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa (S3/4: 0 %), dispneja (S3/4: 0,6 %), kašelj (S3/4: 0 %)
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Slovenian: V študiji TAX316 se je kongestivno srčno popuščanje pojavilo 26 bolnicam v kraku s TAC in 17 bolnicam v kraku s FAC.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom Taxespira100 mg/m 2 pri raku dojke
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%);
Slovenian: Bolezni prebavil navzea (S3/4: 5,0 %), stomatitis (S3/4: 6,0 %), bruhanje (S3/4: 4,2 %), driska (S3/4: 3,4 %), zaprtje (S3/4: 0,5 %)
English: EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Slovenian: EU/1/15/1017/001 6 ml/1 ml vial x 1 vial
English: • For the treatment of metastatic gastric cancer, Taxespira is administered in combination with
Slovenian: • Za zdravljenje metastatskegaraka želodca se zdravilo Taxespira uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: (Study conducted in 8 patients)
Slovenian: (Študija je bila izvedena pri 8 bolnikih)
English: (Possible mechanism)
Slovenian: (Možni mehanizem)
English: Stay in regular contact with your doctor
Slovenian: Bodite v rednem stiku s svojim zdravnikom
English: Protect other people
Slovenian: Zaščita drugih ljudi
English: GSS was derived using ANRS 2007 guidelines.
Slovenian: GSS je bil izračunan po smernicah ANRS 2007.
English: → Don't drive or operate machinery unless you're feeling well.
Slovenian: →Ne vozite vozil in ne upravljate strojev, če se ne počutite dobro.
English: • Change in your body shape
Slovenian: • spremembo v obliki vašega telesa
English: APV exposure was 25-35% lower during pregnancy.
Slovenian: Izpostavljenost APV je bila med nosečnostjo za 25 do 35 % manjša.
English: • difficulty moving.
Slovenian: • težave pri gibanju.
English: Paediatric / other populations
Slovenian: Pediatrična/druge populacije
English: Date of renewal of authorisation: 15 May 2009.
Slovenian: Datum podaljšanja dovoljenja za promet: 15. maj 2009
English: For this reason, it is very important to talk to your doctor about any changes in your health.
Slovenian: Tako je nadvse pomembno, da svojega zdravnika obvestite prav o vsaki spremembi svojega zdravstvenega stanja.
English: Week 144
Slovenian: 144. teden
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2004
Slovenian: DATUM PRVE ODOBRITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 12. julij 2004
English: • If you are taking any other medicines.
Slovenian: • Če jemljete še katerokoli drugo zdravilo.
English: Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Slovenian: Postopke, opisane pod zaporednimi številkami od 4 do 8 ponavljajte na enak način, dokler ne vzamete celotnega odmerka.
English: The reason for this is not known.
Slovenian: Razlog ni znan.
English: (Amprenavir without ritonavir)
Slovenian: (amprenavir brez ritonavirja)
English: Overall the safety profile in these 158 children and adolescents was similar to that observed in the adult population.
Slovenian: V celoti so bile varnostne značilnosti pri teh 158 otrocih in mladostnikih podobne, kot so jih zabeležili v odrasli populaciji.
English: Swallow the tablets whole, with some water or another drink.
Slovenian: Tablete pogoltnite cele skupaj z vodo ali drugo pijačo.
English: The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Slovenian: Uporaba višjih odmerkov ritonavirja lahko spremeni varnostni profil kombinacije in zato ni priporočljiva.
English: To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.
Slovenian: Da bi se temu izognili in preprečili slabšanje bolezni, je zelo pomembno, da vsa zdravila jemljete natančno po zdravnikovih navodilih.
English: Mechanism unknown.
Slovenian: Mehanizem ni znan.
English: Vomiting occurred more frequently amongst paediatric patients.
Slovenian: Bruhanje je bilo pogostejše pri pediatričnih bolnikih.
English: In this case close monitoring is required.
Slovenian: V tem primeru je potreben skrben zdravniški nadzor.
English: → Use an alternative non-hormonal type of contraception such as a condom.
Slovenian: → Uporabljajte alternativno, nehormonsko obliko kontracepcije, kot je kondom.
English: Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo Telzir se sme med nosečnostjo uporabljati le, če potencialne koristi upravičijo potencialno tveganje za plod.
English: This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies.
Slovenian: To je na osnovi podatkov o varnosti, ki so jih dobili od skupno 864 bolnikov, ki so bili izpostavljeni fosamprenavirju/ritonavirju v teh treh študijah.
English: Use with caution.
Slovenian: Uporabljati s previdnostjo.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih
English: Signs to look out for include:
Slovenian: Znaki, na katere morate biti pozorni, so:
English: Concomitant use is not recommended.
Slovenian: Sočasna uporaba ni priporočena.
English: <6 years
Slovenian: < 6 let
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli.
English: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Slovenian: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Španija
English: • Swelling of the face, lips and tongue (angioedema).
Slovenian: • Oteklina obraza, ustnic in jezika (angioedem).
English: • if they drink alcohol
Slovenian: • ki uživajo alkohol.
English: (see section 4.3)
Slovenian: (glejte poglavje 4.4).
English: • Tingling or numbness around the lips and mouth.
Slovenian: • Ščemenje ali otrplost okoli ustnic in ust.
English: Results through 48 weeks of treatment are provided below.
Slovenian: Rezultati po 48 tednih zdravljenja so navedeni v nadaljevanju.
English: Data from this small number further analysed by GSS subgroups need to be interpreted with caution.
Slovenian: Podatke o tem majhnem številu bolnikov je potrebno, pri nadaljni analizi po podskupinah GSS, interpretirati previdno.
English: • Feeling tired
Slovenian: • Utrujenost.
English: Study performed with amprenavir.
Slovenian: Študija izvedena z amprenavirjem.
English: The decrease of (R-) methadone (active enantiomer) is not expected to be clinically significant.
Slovenian: Za zmanjšanje (R-) metadona (aktivni enantiomer) ni pričakovano, da bo klinično pomembno.
English: • methadone (a heroin substitute)
Slovenian: • metadon (nadomestek heroina)
English: (listed in section 6), or to ritonavir.
Slovenian: (navedeno v poglavju 6) ali ritonavir.
English: • fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
Slovenian: • flutikazonpropionat in podobna zdravila za zdravljenje astme, razen če je nujno potrebno.
English: 79 % of subjects received greater than 48 weeks of exposure.
Slovenian: 79 % bolnikov je bilo zdravljenju izpostavljenih več kot 48 tednov.
English: No dose recommendation can be made for children and adolescents with hepatic impairment as no studies have been conducted in these age groups.
Slovenian: Za odmerke pri otrocih in mladostnikih z okvaro jeter ni mogoče dati priporočil, ker študije v teh starostnih skupinah niso bile izvedene.
English: Week 48 AAUCMB (n)
Slovenian: Teden 48 AAUCMB (n)
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Slovenian: Ti simptomi so verjetno posledica okrepitve telesnega imunskega sistema, ko se telo lahko začne boriti s temi okužbami.
English: Following completion of the 48 week treatment period, subjects at European and Canadian sites were eligible to participate in a study extension to Week 144 maintaining their treatment regimen as per the original randomisation.
Slovenian: Po koncu 48-tedenskega obdobja zdravljenja so lahko preiskovanci na evropskih in kanadskih raziskovalnih mestih sodelovali v nadaljevanju študije do 144. tedna, pri čemer so ohranili shemo zdravljenja po prvotni randomizaciji.
English: • warfarin and other medicines that stop blood clotting
Slovenian: • varfarin in druga zdravila za preprečevanje nastajanja krvnih strdkov
English: If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before.
Slovenian: Če ste pozabili vzeti odmerek zdravila Telzir, ga vzemite takoj, ko se spomnite, nato pa nadaljujte z jemanjem zdravila kot pred tem.
English: Do not take Telzir:
Slovenian: Ne jemljite zdravila Telzir:
English: Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Slovenian: 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.
English: You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.
Slovenian: Preverite seznam teh zdravil pod 'Ne jemljite zdravila Telzir' na začetku poglavja 2 tega navodila.
English: Significant ↓ APV expected
Slovenian: Signifikantno  APV pričakovano
English: Resistance patterns were similar to those observed in adults.
Slovenian: Vzorci odpornosti so bili podobni kot pri odraslih.
English: It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor.
Slovenian: Zelo pomembno je, da vzamete celoten dnevni odmerek zdravila Telzir in ritonavirja, kot vam je predpisal zdravnik.
English: Throw away the bottle 28 days after first opening it, but do not throw away any medicines via wastewater or household waste.
Slovenian: Plastenko 28 dni po prvem odprtju zavrzite, vendar zdravila ne smete zavreči v odpadne vode ali med gospodinjske odpadke.
English: The suspension is white to off-white in colour.
Slovenian: Suspenzija je bele do sivo bele barve.
English: Children less than 6 years of age Telzir is not recommended for children less than 6 years old.
Slovenian: Otroci, mlajši od 6 let Zdravilo Telzir ni priporočljivo za otroke, mlajše od 6 let.
English: Let them dry completely before you use them again.
Slovenian: Pred ponovno uporabo morata biti popolnoma suha.
English: On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
Slovenian: V redkih primerih so bile te mišične težave hude (rabdomioliza).
English: Please refer to the relevant product information for these medications (see section 4.5).
Slovenian: Prosimo glejte relevantne informacije o zdravilih za ta zdravila (glejte poglavje 4.5).
English: 33-38 kg Oral suspension
Slovenian: 33-38 kg Peroralna suspenzija
English: • Skin rashes (red, raised or itchy) - if the skin rash is severe, you may have to stop taking this medicine
Slovenian: • Kožni izpuščaj (rdeč, privzdignjen ali srbeč) - če je kožni izpuščaj hud, bo zdravljenje s tem zdravilom morda treba prekiniti.
English: Like all medicines, this medicine can cause side effects, but not everyone gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Tell your doctor or pharmacist if you're taking or have recently taken any other medicinesthese include herbal medicines or other medicines you bought without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste začeli jemati katerokoli zdravilo - vključno z zdravili iz zelišč in drugimi zdravili, ki ste jih dobili brez recepta.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladanje tveganj, zlasti kadar jr tovrstna sprememba posledica prejema novih informacij, ki lahko vplivajo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmajševanjem tveganja).
English: Hertfordshire SG12 0DJ United Kingdom
Slovenian: Hertfordshire SG12 0DJ Velika Britanija
English: • The active substance is fosamprenavir.
Slovenian: • Učinkovina je fosamprenavir.
English: • If you have a known allergy to medicines containing sulphonamide.
Slovenian: • Če ste alergični na zdravila, ki vsebujejo sulfonamide.
English: A 75 % reduction of the standard rifabutin dose (i.e. to 150 mg every other day) is recommended.
Slovenian: Priporočeno je 75 % zmanjšanje standardnega odmerka rifabutina (na 150 mg vsak drug dan).
English: What Telzir is and what it is used for
Slovenian: Kaj je zdravilo Telzir in za kaj ga uporabljamo
English: ITT-E Population TLOVR analysis
Slovenian: ITT-E Populacija TLOVR analiza
English: Therefore, no recommendations can be made in this patient population.
Slovenian: Zato se tega zdravila ne priporoča pri tej skupini bolnikov.
English: High doses (> 200 mg/day) of ketoconazole or itraconazole are not recommended.
Slovenian: Visoki odmerki (> 200 mg/dan) ketokonazola ali itrakonazola niso priporočeni.
English: The dose recommendations for this population therefore take into account the observed food effect (see section 4.2).
Slovenian: Priporočila za odmerjanje za to populacijo upoštevajo opaženi učinek hrane (glejte poglavje 4.2).
English: Women who are HIV-positive must not breast-feed because HIV infection can be passed on to the baby in breast milk.
Slovenian: HIV-pozitivne ženske ne smejo dojiti, saj se okužba z virusom HIV lahko z mlekom prenese na dojenega otroka.
English: Amprenavir exposure unchanged when compared to historical data.
Slovenian: Izpostavljenost amprenavirju je bila nespremenjena v primerjavi s preteklimi podatki.