natgillin/translations-raw huggingface dataset:
The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
U klinička ispitivanja PAH-a nisu bile uključene sljedeće skupine bolesnika s bolestima srca i krvnih žila:
Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
rezultata u 48. tjednu izračunata metodom najmanjih kvadrata iznosila je -51,0 metar (m) u skupini koja je primala placebo, u usporedbi s -64,7 m u skupini liječenoj tadalafilom u dozi od 0,3 mg/kg (p = 0,307) odnosno -59,1 m u skupini liječenoj tadalafilom u dozi od 0,6 mg/kg (p = 0,538).
Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Nakon primjene doze od 10 mg, izloženost tadalafilu (AUC) u ispitanika s blagim i umjerenim oštećenjem jetre (Child-Pugh stadij A i B) usporediva je s izloženošću u zdravih ispitanika.
- any heart problems other than your pulmonary hypertension - problems with your blood pressure - any hereditary eye disease - an abnormality of red blood cells (sickle cell anaemia) - cancer of the bone marrow (multiple myeloma) - cancer of the blood cells (leukaemia) - any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours - a serious liver problem - a serious kidney problem.
- rak koštane srži (multipli mijelom) - rak krvnih stanica (leukemiju) - neku deformaciju penisa ili neželjenu ili dugotrajnu erekciju koja ne prolazi dulje od 4 sata - ozbiljne tegobe s jetrom - ozbiljne tegobe s bubrezima.
The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction.
Nuspojave su uključene u tablicu na temelju podataka prikupljenih nakon stavljanja lijeka u promet, odnosno u kliničkim ispitivanjima primjene tadalafila u liječenju erektilne disfunkcije.
Additionally, 6 minute walk distance and WHO functional class status appeared to be stable in those treated with tadalafil for 1 year.
Osim toga, u bolesnika liječenih tadalafilom godinu dana 6-minutna hodna pruga i funkcionalni status prema SZO-u bili su stabilni.
The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).
Djelotvornost tadalafila u bolesnika koji se već liječe bosentanom nije u potpunosti dokazana (vidjeti dijelove 4.5 i 5.1).
PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine.
Pokazalo se da inhibitori PDE5, kao što je ADCIRCA, pojačavaju učinak toga lijeka na sniženje krvnog tlaka.
Warnings and precautions Talk to your doctor before taking ADCIRCA.
Obratite se svom liječniku prije nego uzmete lijek ADCIRCA.
ADCIRCA 20 mg film-coated tablets Tadalafil
ADCIRCA 20 mg filmom obložene tablete tadalafil
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and, therefore, dosing of tadalafil is not recommended.
Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga primjena tadalafila ne preporučuje.
Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22 %.
Ketokonazol (u dozi od 400 mg na dan) je povećao izloženost (AUC) tadalafilu nakon jedne doze od 20 mg četverostruko, a Cmax za 22%.
Angioedema
angioedem
Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects after a 10 mg dose.
U bolesnika sa šećernom bolešću je izloženost tadalafilu (AUC) nakon doze od 10 mg bila oko 19%
The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1).
Djelotvornost tadalafila u bolesnika koji se već liječe bosentanom nije u potpunosti dokazana (vidjeti dijelove 4.4 i 5.1).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
ADCIRCA contains lactose If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako znate da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
No dose adjustment is warranted.
Nije potrebno prilagođavati dozu.
Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga u tih bolesnika primjena tadalafila ne preporučuje.
Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Dok ste trudni ili dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
Changes in the Borg dyspnoea score were small and non-significant with both placebo and tadalafil 40 mg.
Promjene rezultata na ljestvici zaduhe po Borgu bile su i kod primjene placeba i kod primjene tadalafila u dozi od 40 mg male te nisu bile značajne.
ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
funkcionalnog stupnja II i III prema klasifikaciji SZO-a, u cilju poboljšanja tjelesne sposobnosti (vidjeti dio 5.1).
Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Liječnici moraju pažljivo razmotriti hoće li ti vazodilatacijski učinci nepovoljno djelovati na bolesnike s određenim komorbiditetima, kao što su teška opstrukcija istisnog dijela lijeve klijetke,
When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Nije bilo farmakokinetičkih interakcija kada se tadalafil 10 mg primjenjivao s teofilinom (neselektivnim inhibitorom fosfodiesteraze).
Eli Lilly Holdings Limited Eesti filiaal Tel: +372 6 817 280
Eesti filiaal Tel: +372 6 817 280
The clinical relevance of this finding is uncertain.
Nije sigurno je li ovaj nalaz od kliničkog značaja.
NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg tablets tadalafil
NAZIV LIJEKA ADCIRCA 20 mg tablete tadalafil
Method of administration ADCIRCA is for oral use.
ADCIRCA je namijenjena za peroralnu primjenu.
In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure were observed.
Nisu zabilježene klinički značajne razlike u izloženosti između zdravih ženskih i muških ispitanika nakon primjene jedne i višekratnih doza tadalafila.
Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80 kg male), but in some subjects, postural dizziness and orthostatic hypotension were observed.
(20 mg) nije povećao prosječno sniženje krvnog tlaka izazvano alkoholom (0,7 g/kg ili približno
Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
(uključujući kongestiju nosa, kongestiju sinusa i rinitis)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg tadalafil
NAVOĐENJE DJELATNIH TVARI Jedna filmom obložena tableta sadrži 20 mg tadalafila
Tell your doctor or pharmacist if you are already taking: - bosentan (another treatment for pulmonary aterial hypertension) - nitrates (for chest pain) - alpha blockers used to treat high blood pressure or prostate problems.
Obavijestite svog liječnika ili ljekarnika ako već uzimate: - bosentan (drugi lijek za liječenje plućne arterijske hipertenzije)
NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets
NAZIV LIJEKA ADCIRCA 20 mg filmom obložene tablete
Gastrointestinal disorders Nausea,
Poremećaji probavnog sustava mučnina,
Not known1
Nepoznato1
Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).
uključujući tadalafil, je kontraindicirana (vidjeti dio 4.3).
Priapism has been reported in men treated with PDE5 inhibitors.
U muškaraca liječenih inhibitorima PDE5 prijavljeni su slučajevi prijapizma.
Uncommon (may affect up to 1in 100 people) - seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.
prisutnost krvi u spermi i/ili mokraći, visok krvni tlak, brzo kucanje srca, iznenadna srčana smrt i zvonjava u ušima.
At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo.
(AUC) za 26%, a Cmax za 70% u odnosu na primjenu oralnog kontraceptiva s placebom.
Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mmHg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p<0.05).
Tadalafil u dozi od 40 mg je povećao minutni volumen srca (0,6 l/min) te snizio plućni arterijski tlak (-4,3 mmHg) i plućni krvožilni otpor
ADCIRCA contains the active substance tadalafil.
Što je ADCIRCA i za što se koristi ADCIRCA sadrži djelatnu tvar tadalafil.
Other side effects have been reported:
Neke su nuspojave prijavljene rijetko:
Musculoskeletal, connective tissue and bone disorders Myalgia,
Poremećaji dišnog sustava, prsišta i sredoprsja nazofaringitis
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
(RMP), oba dokumenta mogu biti podnesena istodobno.
For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
CYP3A4, poput rifampicina, (vidjeti dio 4.5).
For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
poput ketokonazola ili ritonavira, (vidjeti dio 4.5).
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Nositelj odobrenja: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska Proizvođač: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Španjolska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
Pain in extremity (including limb discomfort)
(uključujući nelagodu u udovima)
Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Istodobna primjena tadalafila (10 mg ili 20 mg) ne utječe na koncentraciju alkohola.
Azole Antifungals (e.g. ketoconazole)
Inhibitori citokroma P450 Azolni antimikotici (npr. ketokonazol)
Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Poremećaji oka zamagljen vid nearterijska prednja ishemijska optička neuropatija, okluzija krvnih žila mrežnice,
These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is unknown: - swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Ti događaji nisu zabilježeni u kliničkim ispitivanjima za plućnu arterijsku hipertenziju te im je stoga učestalost nepoznata:
What ADCIRCA contains
Kako ADCIRCA izgleda i sadržaj pakiranja
Hepatic impairment
moždani udar2
It may harm them,
povraćanje,
Priapism5, Penile haemorrhage,
prijapizam5, krvarenje iz penisa, hematospermija dugotrajna erekcija
What ADCIRCA looks like and contents of the pack ADCIRCA 20 mg comes as orange film-coated tablets.
ADCIRCA 20 mg su narančaste filmom obložene tablete.
Renal and hepatic impairment
Poremećaji bubrega i mokraćnog sustava hematurija
Vision
PRIMJENU
Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone.
10 mg dvostruko, a Cmax za 15%, u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila.
NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg film-coated tablets tadalafil
Uputa o lijeku: Informacije za korisnika ADCIRCA 20 mg filmom obložene tablete tadalafil
Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Kod uzimanja tadalafila i drugih inhibitora PDE5 prijavljene su smetnje vida i slučajevi nearterijske prednje ishemijske optičke neuropatije.
Unopened vial 3 years.
Neotvorena bočica 3 godine.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego počnete koristiti ovaj lijek jer sadrži Vama važne podatke.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 January 2016
Datum prvog odobrenja: 18 siječanj 2016
* Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10%.
* Definicije pojmova učestalosti: vrlo često - ≥ 10%; često - > 5% i < 10%.
The results of these analyses of efficacy are summarised in the table below:
Rezultati tih analiza djelotvornosti su sažeti u tablici koja slijedi:
95 % CI for HR Non-inferiority p-value (HR)
95% CI za HR p-vrijednost za neinferiornost (HR)
Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Fòti ùt 56., Budimpešta, 1047, Mađarska
Grade toxicit y (%)
Svi stupnjevi toksičnost i (%)
319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
319, Pinner Road North Harrow Middlesex HA1 4HF Ujedinjeno Kraljevstvo
Increased skin pigmentation
Pojačana pigmentacija kože
Do not use Pemetrexed Accord - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Nemojte koristiti lijek Pemetrexed Accord - ako ste alergični na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Frequency estimate: 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) and not known (cannot be estimated from available data).
Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Based on the planned date of your infusion of Pemetrexed Accord and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Ovisno o planiranom datumu primjene infuzije lijeka Pemetrexed Accord i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete koristiti i kada ih možete koristiti.
Creatinine clearance should be  45 ml/min.
Klirens kreatinina mora biti  45 ml/min.
Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Farmakoterapijska skupina: antineoplastici, analozi folatne kiseline, ATK oznaka: L01BA04
If you are pregnant, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
Not known: frequency cannot be estimated from the available data
Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
Talk to your doctor or hospital pharmacist or nurse before using Pemetrexed Accord.
Obratite se svom liječniku ili bolničkom ljekarniku ili medicinskoj sestri prije nego uzmete lijek Pemetrexed Accord.
a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
a Statistički značajan za neinferiornost, a cijeli interval pouzdanosti za HR nalazi se znatno ispod granice neinferiornosti od 1,17645 (p < 0,001).
The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see Section 4.2).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja pemetrekseda u svim podskupinama pedijatrijske populacije za odobrene indikacije (vidjeti dio 4.2).
What Pemetrexed Accord is and what it is used for
Što je Pemetrexed Accord i za što se koristi
Event**
Događaj*
Please tell your doctor if you are taking any medicines for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Obavijestite svog liječnika ako uzimate bilo koji lijek protiv bolova ili upale (otekline), poput lijekova iz skupine takozvanih „nesteroidnih protuupalnih lijekova“ (NSAIL), uključujući lijekove koje ste nabavili bez liječničkog recepta (poput ibuprofena).
Your doctor will discuss with you the potential risk of taking Pemetrexed Accord during pregnancy.
Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Pemetrexed Accord u trudnoći.
In clinical studies, patients with creatinine clearance of  45 ml/min required no dose adjustments other than those recommended for all patients.
U kliničkim ispitivanjima u bolesnika s klirensom kreatinina  45 ml/min nisu bile potrebne druge prilagodbe doze osim onih preporučenih za sve bolesnike.
Pemetrexed N = 265
Pemetreksed n = 265
Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Accord has finished.
Cisplatin se također primjenjuje infuzijom u jednu od vena i daje se približno 30 minuta nakon završetka infuzije lijeka Pemetrexed Accord.
Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Mnogi bolesnici u kojih se to dogodilo imali su podležeće čimbenike rizika za razvoj bubrežnih događaja, uključujući dehidraciju, prethodno postojeću hipertenziju ili dijabetes.
Pemetrexed Accord is a medicine used in the treatment of cancer.
Pemetrexed Accord je lijek koji se koristi za liječenje raka.
Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be  3 times upper limit of normal.
Vrijednosti alkalne fosfataze (ALP), aspartat aminotransferaze (AST ili SGOT) i alanin aminotransferaze (ALT ili SGPT) moraju biti  3 puta iznad gornje granice normalnih vrijednosti.
Do not use this medicine if you notice any visible signs of deterioration.
Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove odstupanja u kakvoći.
In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Starije osobe: U kliničkim ispitivanjima nije bilo naznaka da bolesnici u dobi od 65 ili više godina imaju veći rizik nuspojava u usporedbi s bolesnicima mlađima od 65 godina.
First line doublet therapy containing pemetrexed was not included.
Nije bila uključena prva linija dvojne terapije koja je sadržavala pemetreksed.
The total bilirubin should be  1.5 times upper limit of normal.
Vrijednost ukupnog bilirubina mora biti ≤ 1,5 puta iznad gornje granice normalnih vrijednosti.
Interactions common to all cytotoxics:
Interakcije koje su zajedničke svim citotoksičnim lijekovima:
You can also report side effects directly via the national reporting system listed in Appendix V .
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o učincima lijeka na sposobnost upravljanja vozilima i rada na strojevima.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2 °C do 8 C, osim ako je rekonstitucija/razrjeđivanje nije obavljeno u kontroliranim i validiranim aseptičkim uvjetima.
Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Alergijska reakcija: kožni osip / osjećaj pečenja ili bockanja Infekcija, uključujući sepsu
What you need to know before you use Pemetrexed Accord
Što morate znati prije nego počnete koristiti lijek Pemetrexed Accord
Renal disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Kratice: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; CTCAE = Zajednička terminologija za nuspojave; NCI = Nacionalni institut za rak; SGOT = serumska glutamat-oksaloctena aminotransferaza;
Log Rank p-value* Overall response rate**
Log-rang p-vrijednost* Stopa ukupnog odgovora**
Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors (see section 4.8).
U većine bolesnika u kojih su opaženi takvi događaji od ranije su postojali kardiovaskularni čimbenici rizika (vidjeti dio 4.8).
A total of 213 patients (48.3 %) completed ≥ 6 cycles and a total of 103 patients (23.4 %) completed ≥ 10 cycles of treatment with pemetrexed.
Ukupno je 213 bolesnika (48,3%) završilo ≥ 6 ciklusa, dok su 103 bolesnika (23,4%) završila ≥ 10 ciklusa liječenja pemetreksedom.
At the time of this final survival analysis, 28.7 % of patients were alive or lost to follow up on the pemetrexed arm versus 21.7 % on the placebo arm.
U vrijeme ove konačne analize preživljenja 28,7% bolesnika u skupini liječenoj pemetreksedom bilo je živo ili izgubljeno iz praćenja, u odnosu na 21,7% bolesnika u skupini koja je primala placebo.
Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Rezultati in vitro ispitivanja na ljudskim jetrenim mikrosomima pokazali su da pemetreksed vjerojatno neće izazivati klinički značajnu inhibiciju metaboličkog klirensa lijekova koji se metaboliziraju posredstvom CYP3A, CYP2D6, CYP2C9 i CYP1A2.
Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Accord.
Prije svake infuzije uzet će Vam se uzorak krvi kako bi se provjerilo jesu li Vam bubrežna ili jetrena funkcija dovoljno dobre i imate li dovoljno krvnih stanica da biste primili lijek Pemetrexed Accord.
Clinical efficacy
Klinička djelotvornost: