natgillin/translations-raw huggingface dataset:
By blocking TNF-alpha, certolizumab was expected to improve the inflammation and other symptoms of the disease.
Po pričakovanjih bi naj certolizumab z blokiranjem TNF-alfa izboljšal vnetje in druge simptome bolezni.
CIMZIA is a powder and solvent that is made up into a solution for injection under the skin.
Zdravilo CIMZIA je prašek in vehikel za pripravo raztopine za injiciranje pod kožo.
What was CIMZIA expected to be used for?
Za kaj naj bi se zdravilo CIMZIA uporabljalo?
Hence, the CHMP recommended that CIMZIA be refused marketing authorisation.
CHMP je zato priporočil zavrnitev dovoljenja za promet z zdravilom CIMZIA.
In CIMZIA, certolizumab has been ‘pegylated' (attached to a chemical called polyethylene glycol).
V zdravilu CIMZIA je certolizumab „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
It contains the active substance certolizumab pegol.
Vsebuje zdravilno učinkovino certolizumab pegol.
Certolizumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Učinkovina Certolizumab je bila zasnovana tako, da se veže na obveščevalno molekulo (kemični prenašalec) v telesu, ki jo imenujemo tumor nekrotizirajoči faktor alfa (TNF-alfa).
How is CIMZIA expected to work?
Kako naj bi zdravilo CIMZIA delovalo?
The active substance in CIMZIA, certolizumab pegol, is an immunosuppressant medicine.
Zdravilna učinkovina certolizumab pegol, ki jo vsebuje zdravilo CIMZIA, je imunosupresiv.
{ mm/yyyy}
{ MM/LLLL}
You may need further blood tests.
Morda bodo potrebne nadaljnje krvne preiskave.
This leaflet was last revised in {mm/yyyy}
Navodilo je bilo nazadnje revidirano {MM/LLLL}.
Disorientation (and all aggravations)
dezorientiranost (in vsa poslabšanja)
The most commonly reported adverse reactions are diarrhoea and headache, both occurring in approximately 1% of patients.
Najpogosteje zabeležena neželena učinka sta bila driska in glavobol, oba sta se pojavila pri približno 1 % bolnikov.
You must not use CONTROLOC Control if you are taking HIV protease inhibitors.
Zdravila CONTROLOC Control ne smete uporabljati, če jemljete zaviralce proteaze HIV.
To avoid this interference, CONTROLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Da bi to preprečili, je treba vsaj pet dni pred meritvami CgA prekiniti zdravljenje z zdravilom CONTROLOC Control (glejte poglavje 5.1).
What CONTROLOC Control is and what it is used for
Kaj je zdravilo CONTROLOC Control in za kaj ga uporabljamo
What CONTROLOC Control is and what it is used for What you need to know before you take CONTROLOC Control How to take CONTROLOC Control Possible side effects
Kaj je zdravilo CONTROLOC Control in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CONTROLOC Control Kako jemati zdravilo CONTROLOC Control Možni neželeni učinki
What you need to know before you take CONTROLOC Control
Kaj morate vedeti, preden boste vzeli zdravilo CONTROLOC Control
After administration of pantoprazole to patients with liver impairment (Child-Pugh classes A, B and C) the half-life values increased to between 3 and 7 h and the AUC values increased by a factor of 3-6, whereas the Cmax only increased slightly by a factor of 1.3 compared with healthy subjects.
Pri uporabi pantoprazola pri bolnikih z okvaro jeter (razredi A, B in C po Child-Pugh-u) se, v primerjavi z zdravimi osebami, razpolovni čas podaljša na 3 do 7 ur, vrednosti AUC zvišajo za 3-do 6-krat, vrednost Cmax pa se komaj opazno zviša, in sicer za faktor 1,3.
If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping CONTROLOC Control.
Če se pojavijo lezije, zlasti na koži, ki je izpostavljena soncu, in sočasna artralgija, mora bolnik takoj poiskati zdravniško pomoč, zdravstveni delavec pa mora razmisliti o prekinitvi zdravljenja z zdravilom CONTROLOC Control.
If possible take your medicine and this leaflet with you
Če je mogoče, vzemite s seboj zdravilo in to navodilo.
Other side effects include: - Common (may affect up to 1 in 10 people): Benign polyps in the stomach.
Drugi možni neželeni učinki so: - Pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): benigni polipi v želodcu
Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany
Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Pri uporabi pantoprazola so poročali o naslednjih neželenih učinkih, ki so v tabeli v nadaljevanju navedeni v skladu z navedbo pogostnosti po MedDRA: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Pharmacotherapeutic group: Drugs for acid related disorders Proton pump inhibitors, ATC code: A02BC02
Farmakoterapevtska skupina: zdravila za kislinsko pogojene bolezni, zaviralci protonske črpalke, oznaka ATC: A02BC02
How to store CONTROLOC Control Contents of the pack and other information
Shranjevanje zdravila CONTROLOC Control Vsebina pakiranja in dodatne informacije
- warfarin and phenprocoumon (used to thin blood and prevent clots).
- varfarin ali fenprokumon (uporabljamo ju za redčenje krvi in preprečevanje nastanka krvnih strdkov).
CONTROLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Zdravilo CONTROLOC Control je na voljo v Alu/Alu pretisnih omotih s kartonsko oporo ali brez nje.
CONTROLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Zdravilo CONTROLOC Control vsebuje zdravilno učinkovino pantoprazol, ki zavira “črpalko”, ki proizvaja želodčno kislino.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Druga zdravila in zdravilo CONTROLOC Control Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets
Alu/Alu pretisni omoti s kartonsko oporo ali brez nje, ki vsebujejo 7 ali 14 gastrorezistentnih tablet.
However, you may take CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Zdravilo CONTROLOC Control lahko po potrebi jemljete skupaj z antacidi (npr. magaldrat, alginska kislina, natrijev hidrogenkarbonat, aluminijev hidroksid, magnezijev karbonat ali kombinacije naštetih).
What CONTROLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Izgled zdravila CONTROLOC Control in vsebina pakiranja Gastrorezistentne tablete so rumene, ovalne, obojestransko izbočene filmsko obložene tablete z oznako “P20” na eni strani.
CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Zdravilo CONTROLOC Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka uporabnost je odvisna od pH želodčnega soka (npr. ketokonazol).
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC Control, but this medicine is not meant to bring immediate relief.
Simptomi kislega refluksa in zgage se lahko ublažijo že po enem dnevu zdravljenja z zdravilom CONTROLOC Control, vendar pa to zdravilo ni namenjeno za dosego takojšnjega olajšanja.
CONTROLOC Control should not be used during breast-feeding.
Zdravila CONTROLOC Control se med dojenjem ne sme uporabljati.
Do not take CONTROLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Ne jemljite zdravila CONTROLOC Control z drugimi zdravili, ki zavirajo izločanje želodčne kisline, kot so drugi zaviralci protonske črpalke (omeprazol, lansoprazol ali rabeprazol) ali antagonisti histaminskih receptorjev H2 (npr. ranitidin, famotidin).
What CONTROLOC Control contains - The active substance is pantoprazole.
Kaj vsebuje zdravilo CONTROLOC Control - Zdravilna učinkovina je pantoprazol.
CONTROLOC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila CONTROLOC Control pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
How to take CONTROLOC Control
Kako jemati zdravilo CONTROLOC Control
Do not take a double dose to make up for the forgotten dose.
Če ste pozabili vzeti zdravilo CONTROLOC Control Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
- if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
- ste naročeni na specifično preiskavo krvi (kromogranin A) - če jemljete zaviralce proteaze HIV, kot sta atazanavir; nelfinavir (za zdravljenje okužbe s HIV)
- Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
- Tiskarsko črnilo: šelak, rdeči, črni in rumeni železov oksid (E 172) ter koncentrirana raztopina amoniaka.
HIV-infection) See ‘Other medicines and CONTROLOC Control'.
Glejte “Druga zdravila in zdravilo CONTROLOC Control” v nadaljevanju.
CONTROLOC Control 20 mg gastro-resistant tablets Pantoprazole
CONTROLOC Control 20 mg gastrorezistentne tablete pantoprazol
- if you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with CONTROLOC Control.
- če se pojavi kožni izpuščaj, zlasti na koži, ki je izpostavljena soncu, čim prej obvestite zdravnika,
CONTROLOC Control'.
- Navodilo shranite.
CONTROLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
CONTROLOC Control 20 mg gastrorezistentnih tablet se ne sme žvečiti ali drobiti.
Co-administration of Pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.5).
Sočasno zdravljenje skupaj z pantoprazolom z zaviralci proteaze HIV, pri katerih je absorpcija odvisna od pH želodčne kisline, kot so atazanavir, nelfinavir; zaradi znatnega zmanjšanja njihove biološke uporabnosti (glejte poglavje 4.5).
If you take more CONTROLOC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Če ste vzeli večji odmerek zdravila CONTROLOC Control, kot bi smeli Če ste vzeli večji odmerek zdravila CONTROLOC Control, kot bi smeli, o tem obvestite svojega zdravnika ali farmacevta.
- You should not take CONTROLOC Control tablets for more than 4 weeks without consulting a doctor.
- CONTROLOC Control tablet ne smete jemati dlje kot 4 tedne brez posveta z zdravnikom.
Do not take CONTROLOC Control tablets for more than 4 weeks without consulting your doctor.
Ne jemljite tablet CONTROLOC Control več kot 4 tedne brez posveta pri zdravniku.
CONTROLOC Control 20 mg gastro-resistant tablets
CONTROLOC Control 20 mg gastrorezistentne tablete
Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).
Sočasna uporaba pantoprazola in zaviralcev proteaze HIV, pri katerih je absorpcija odvisna od pH želodčne kisline, kot so atazanavir, nelfinavir, je kontraindicirana zaradi znatnega zmanjšanja njihove biološke uporabnosti (glejte poglavje 4.3).
CONTROLOC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Zdravilo CONTROLOC Control uporabljamo za kratkotrajno zdravljenje simptomov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
How to store CONTROLOC Control
Shranjevanje zdravila CONTROLOC Control
CONTROLOC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Zdravilo CONTROLOC Control je indicirano za kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
Agranulocytosis Thrombocytopenia ; Leukopenia,
Bolezni krvi in limfatičnega sistema agranulocitoza trombocitopenija, levkopenija, pancitopenija
Stevens-Johnson syndrome; Lyell syndrome;
Stevens-Johnsonov sindrom, Lyellov sindrom, multiformni eritem, fotosenzitivnost, subakutni kožni eritematozni lupus (glejte poglavje 4.4)
CONTROLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Pri bolnikih, mlajših od 18 let, podatki o varnosti tega zdravila namreč niso na voljo.
Pregnancy and, breast-feeding
Nosečnost in dojenje
However adverse reactions such as dizziness and visual disturbances may occur (see section 4.8).
Zdravilo CONTROLOC Control nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar pa se lahko pojavijo neželeni učinki, kot so omotica in motnje vida (glejte poglavje 4.8).
Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
- če jemljete zaviralce proteaze HIV, kot sta atazanavir, nelfinavir (za zdravljenje okužbe z virusom HIV).
Do not take CONTROLOC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Ne jemljite zdravila CONTROLOC Control - če ste alergični na pantoprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Liver enzymes increased (transaminas es, γ-GT)
Bolezni jeter, žolčnika in žolčevodov zvišana vrednost jetrnih encimov (aminotransferaze , γ-GT)
Abdominal distension and bloating; Constipation ; Dry mouth; Abdominal pain and discomfort
driska, navzea / bruhanje, napihovanje in napenjanje v trebuhu, zaprtost, suha usta, bolečine in neugodje v trebuhu mikroskopski kolitis
- fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Če zdravilo CONTROLOC Control prejemate daljše obdobje, lahko to povzroči dodatna tveganja, kot so: - zmanjšana absorpcija vitamina B12 in pomanjkanje vitamina B12, če že imate nizke telesne zaloge vitamina B12 - zlom kolka, zapestja ali hrbtenice, še posebej, če že trpite zaradi osteoporoze ali če jemljete kortikosteroide (ki lahko povečajo tveganje za osteoporozo).
Hepatocellular injury; Jaundice; Hepatocellular failure
Bolezni živčevja glavobol, omotica motnje okušanja parestezija
CONTROLOC Control may stop certain other medicines from working properly.
Če jemljete metotreksat, lahko zdravnik začasno prekine zdravljenje z zdravilom CONTROLOC
Stop taking CONTROLOC Control when you are completely symptom-free.
Ko simptomi bolezni popolnoma minejo, zdravilo CONTROLOC Control nehajte jemati.
Telephone: 0800 825332 4 Telefax:
Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Nemčija tel.: 0800 825332 4 faks: 0800 825332 9
1 After reconstitution, each dose (2 ml) contains 1.4-2.5 x 106 chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells .
1 Po mešanju vsak odmerek (2 ml) vsebuje 1,4-2,5 × 106 hondrogeno induciranih konjskih alogenskih mezenhimskih matičnih celic, pridobljenih iz periferne krvi.
1 vial of stem cell suspension + 1 vial of plasma suspension
1 viala s suspenzijo matičnih celic + 1 viala s suspenzijo plazme nič dni
Suspension (plasma): vial (plastic).
Suspenzija (plazma): viala (plastika).
Horses Intraarticular use Suspension (stem cells): vial (plastic).
Suspenzija (matične celice): viala (plastika).
Date of first authorisation: 03 August 2009 Date of latest renewal: 16 May 2014
Datum prve odobritve: 03. avgust 2009 Datum zadnjega podaljšanja: 16. maj 2014
No formal statistical comparisons were planned.
Formalnih statističnih primerjav pri tem niso načrtovali.
• Protein in the urine
• beljakovine v urinu
• Feeling weak or tired
• občutek šibkosti ali utrujenosti
CgA: Chromogranin A
CgA: kromogranin A
Women who could potentially become pregnant should use highly effective contraception during treatment.
Ženske, ki bi lahko zanosile, morajo med zdravljenjem uporabljati zelo učinkovito kontracepcijo.
Frequency based upon number of women from 10 to 55 years of age in the pooled data
e pogostnost temelji na številu žensk v starosti od 10 do 55 let iz združene baze podatkov
Your doctor will tell you how many tablets of Afinitor to take.
Zdravnik vam bo povedal, koliko tablet zdravila Afinitor morate vzeti.
• Passing urine more often during daytime
• pogostejše odvajanje urina čez dan
Fifty-eight percent of the patients in both arms received prior systemic therapy.
Oseminpetdeset odstotkov bolnikov iz obeh skupin je predhodno prejemalo sistemsko zdravljenje.
Your doctor will discuss with you whether you should take this medicine during your pregnancy.
Zdravnik se bo pogovoril z vami, ali bi morali med nosečnostjo jemati to zdravilo.
Children and adolescents Afinitor is not to be used in children or adolescents (age below 18 years).
Otroci in mladostniki Zdravilo Afinitor ni namenjeno uporabi pri otrocih in mladostnikih (starih manj kot 18 let).
NSE: Neuron specific enolase
NSE: nevronsko specifična enolaza
What Afinitor is and what it is used for
Kaj je zdravilo Afinitor in za kaj ga uporabljamo
Open the blister just before taking the tablets.
Pretisni omot odprite šele tik pred uporabo tablet.
ULN: Upper limit of normal
ZMN: zgornja meja normalnih vrednosti
Primary analysis All (blinded independent central review)
Primarna analiza vsi (slepo neodvisno centralno pregledovanje)
Probability (%)
verjetnost (%)
The Independent Data Monitoring Committee recommended termination of this trial at the time of the second interim analysis as the primary endpoint had been met.
Neodvisni odbor za spremljanje podatkov (Independent Data Monitoring Committee) je priporočil, da bi študijo zaključili po drugi vmesni analizi podatkov, ker je presoja primarnega cilja opazovanja že dosežena.
• Trouble sleeping (insomnia)
• težave s spanjem (nespečnost)
• Pink eye or red eye (conjunctivitis)
• rožnato ali rdeče obarvano oko (konjunktivitis)
The increase in exemestane levels is unlikely to have an impact on efficacy or safety.
Zvišanje koncentracije eksemestana po vsej verjetnosti ne vpliva na učinkovitost ali varnost zdravljenja.
You might need treatment with a mouthwash, gel or other products.
Morda boste potrebovali zdravljenje s tekočino za izpiranje ust, gelom ali drugimi izdelki.
Afinitor could harm your unborn baby and is not recommended during pregnancy.
Zdravilo Afinitor lahko škoduje nerojenemu otroku in med nosečnostjo ni priporočeno.
Table 3 Adverse reactions reported in clinical studies
Preglednica 3 Neželeni učinki, o katerih so poročali v kliničnih študijah
The safety and efficacy of Afinitor in children aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Afinitor pri otrocih, starih 0 do 18 let, nista bili dokazani.
Take Afinitor once a day, at about the same time every day, consistently either with or without food.
Zdravilo Afinitor jemljite enkrat na dan, vsak dan ob približno istem času, vedno s hrano ali vedno brez nje.
The tablets should not be chewed or crushed.
Tablet se ne sme žvečiti ali drobiti.
Afinitor may affect the way some other medicines work.
Zdravilo Afinitor lahko vpliva na delovanje nekaterih drugih zdravil.
In this case, a dose of 2.5 mg daily must not be exceeded.
V tem primeru se ne sme prekoračiti odmerka 2,5 mg na dan.
If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual.
Če bolnik pozabi vzeti odmerek, naj ne jemlje dodatnega odmerka, temveč naj vzame samo naslednji predpisani odmerek kot običajno.
Randomisation was stratified by documented sensitivity to prior hormonal therapy and by the presence of visceral metastasis.
Randomizacija je bila stratificirana glede na dokumentirano občutljivost na predhodno hormonsko zdravljenje in glede na prisotnost visceralnih metastaz.
Re-initiate treatment at same dose.
Ponovno začnite zdravljenje v enakem odmerku.
Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
Other medicines and Afinitor
Druga zdravila in zdravilo Afinitor
If you have liver problems, your doctor may start you on a lower dose of Afinitor (2.5, 5 or 7.5 mg per day).
Če imate težave z jetri, vam bo zdravnik morda predpisal nižji začetni odmerek zdravila Afinitor (2,5, 5 ali 7,5 mg na dan).
Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Zaradi razlik med posamezniki priporočeni odmerki morda ne bodo najbolj ustrezni pri vseh, zato je priporočeno skrbno spremljanje imatinib
Most of the side effects are mild to moderate and will generally disappear if your treatment is interrupted for a few days.
Večina neželenih učinkov je blago do zmerno izraženih in večinoma izzvenijo, če za nekaj dni prekinete zdravljenje.
Confirmed objective tumour responses were observed in 5 patients (2%) receiving Afinitor, while none were observed in patients receiving placebo.
Potrjen objektivni odziv tumorja so zabeležili pri 5 bolnikih (2 %), ki so jemali zdravilo Afinitor, medtem ko pri bolnikih, ki so jemali placebo, niso zabeležili nobenega.
• Pain in the mouth
• bolečine v ustih
if you have previously had hepatitis B, because this may be reactivated during treatment with Afinitor (see section 4 ‘Possible side effects').
če ste imeli kdaj prej hepatitis B, ker se med zdravljenjem z zdravilom Afinitor virus lahko reaktivira (glejte poglavje 4 “Možni neželeni učinki”).
Afinitor should be administered orally once daily at the same time every day, consistently either with or without food (see section 5.2).
Zdravilo Afinitor je treba vzeti peroralno enkrat na dan, vsak dan ob istem času, vedno s hrano ali vedno brez nje (glejte poglavje 5.2).
Light fat meals reduced AUC by 32% and Cmax by 42%.
Obroki z nizko vsebnostjo maščob so znižali AUC za 32 %, Cmax pa za 42 %.
If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.
Če imate vprašanja o zdravilu Afinitor ali vas zanima, zakaj so vam ga predpisali, se obrnite na svojega zdravnika.
In the safety pooling, 37% of the Afinitor-treated patients were ≥65 years of age.
Po združenih podatkih o varnosti zdravila je bilo 37 % bolnikov, ki so prejemali zdravilo Afinitor, starih ≥65 let.
If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily.
Če je treba odmerek znižati, je priporočeni odmerek 5 mg dnevno, ne sme pa biti nižji od 5 mg dnevno.
Therefore, the safety and efficacy of Afinitor in patients with functional carcinoid tumours have not been established.
Varnost in učinkovitost uporabe zdravila Afinitor pri bolnikih s funkcionalnimi karcinoidnimi tumorji torej nista bili potrjeni.
Based on analysis of population pharmacokinetics, CL/F is on average 20% higher in black transplant patients.
Na podlagi analize populacijske farmakokinetike je CL/F pri bolnikih črne rase po presaditvi povprečno za 20 % večji.