natgillin/translations-raw huggingface dataset:
Patients should not take other medicines that lower uric acid levels during Krystexxa treatment, so that the effect of Krystexxa can be clearly judged.
Zdravnik lahko z zdravljenjem z zdravilom Krystexxa nadaljuje le toliko časa, dokler to bolniku koristi, torej, dokler njegove ravni sečne kisline v krvi ostajajo nižje od 6 mg/dl. Bolniki med zdravljenjem z zdravilom Krystexxa ne smejo jemati drugih zdravil, ki znižujejo ravni sečne kisline, tako da je mogoče učinek zdravila Krystexxa jasno oceniti.
These measures will help protect the environment.
Taki ukrepi pomagajo varovati okolje
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 January 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 18. januar 2016
Not known: frequency cannot be estimated from the available data
Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
* Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10%.
* Definicija pogostnosti: Zelo pogosto - > 10 %; Pogosto - > 5 % in < 10 %.
Do not use this medicine if you notice any visible signs of deterioration.
Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja.
Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Madžarska
Calculate the dose and the number of Pemetrexed Accord vials needed.
Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed Accord.
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.
Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed Accord in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom jemanja tega zdravila, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The total bilirubin should be  1.5 times upper limit of normal.
Celotni bilirubin mora biti  1,5-kratnika zgornje meje normalnih vrednosti.
Driving and using machines Pemetrexed Accord may make you feel tired.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pemetreksed Accord lahko povzroči, da se boste počutili utrujene.
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).
Pogostnosti so določene kot: zelo pogosto (≥1/10), pogosto ( 1/100 do < 1/10), občasno (≥1/1000 do < 1/100), redko (≥1/10.000 do < 1/1000), zelo redko (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The percentage of patients that received post study treatment was 64.3 % for pemetrexed and 71.7 % for placebo.
Odstotek bolnikov, ki so prejeli zdravljenje po študiji, je bil 64,3 % za pemetreksed in 71,7 % za placebo.
Instructions for use, handling and disposal.
Navodila za uporabo, ravnanje z zdravilom in odlaganje.
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).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s pemetreksedom za vse skupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
Efficacy and safety were measured from the time of randomisation after completion of first line (induction) therapy.
Učinkovitost in varnost sta bili merjeni od časa randomizacije po zaključku zdravljenja prve izbire (indukcije).
Side effects with Pemetrexed Accord may include:
Neželeni učinki z zdravilom Pemetreksed Accord lahko vključujejo:
What Pemetrexed Accord is and what it is used for
Kaj je zdravilo Pemetreksed Accord in za kaj ga uporabljamo
Do not use Pemetrexed Accord - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Pemetreksed Accord: - če ste alergični na pemetreksed ali na katerokoli sestavino tega zdravila (navedeno v poglavju
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju poleg oznake EXP.
Creatinine clearance should be  45 ml/min.
Očistek kreatinina mora biti  45 ml/min.
Your doctor will discuss with you the potential risk of taking Pemetrexed Accord during pregnancy.
S svojim zdravnikom se pogovorite o možnem tveganju pri prejemanju zdravila Pemetreksed Accord v času nosečnosti.
The 1 year and 2 year survival rates for patients on pemetrexed were 58 % and 32 % respectively, compared to 45 % and 21 % for patients on placebo.
Stopnji preživetja pri 1 in pri 2 letih pri bolnikih, ki so prejemali pemetreksed sta bili 58 % in 32 %, v primerjavi s 45 % in 21 % pri bolnikih, ki so prejemali placebo.
Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Farmakoterapevtska skupina: antineoplastiki, analogi folne kisline, Oznaka ATC: L01BA04
Premedication regimen
Režim premedikacije
This medicine is for single use only.
To zdravilo je namenjeno samo enkratni uporabi.
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Če niste prepričani, vprašajte zdravnika ali farmacevta, ali so katera od vaših zdravil NSAID-i.
What Pemetrexed Accord is and what it is used for What you need to know before you use Pemetrexed Accord How to use Pemetrexed Accord Possible side effects
Kaj je zdravilo Pemetreksed Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Accord Kako uporabljati zdravilo Pemetreksed Accord Možni neželeni učinki
What you need to know before you use Pemetrexed Accord
Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Accord
Pemetrexed Accord is a medicine used in the treatment of cancer.
Pemetreksed Accord je zdravilo, ki ga uporabljamo pri zdravljenju raka.
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.
Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja vaših ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila Pemetreksed Accord.
Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be  3 times upper limit of normal.
Alkalna fosfataza (AF), aspartatna aminotransferaza (AST ali SGOT) in alaninska aminotransferaza (ALT ali SGPT) morajo biti  3-kratnik zgornje meje normalnih vrednosti.
** In the pemetrexed/cisplatin arm, randomized and treated (N= 225) and fully supplemented (N = 167)
**V veji zdravljenja s pemetreksedom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
Event*
Dogodek*
Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for Pemetrexed Accord used as a single agent or in combination with cisplatin.
Po okrevanju bolnike ponovno zdravimo z uporabo smernic v Preglednicah 1, 2 in 3, ki veljajo za zdravilo Pemetreksed Accord, če ga uporabljamo kot edino učinkovino ali v kombinaciji s cisplatinom.
Interactions common to all cytotoxics:
Medsebojna delovanja, ki so skupna vsem citotoksičnim zdravilom:
The recommended dose of Pemetrexed Accord is 500 milligrams for every square metre of your body's surface area.
Priporočeni odmerek zdravila Pemetreksed Accord je 500 miligramov za vsak kvadratni meter površine vašega telesa.
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.
Skupno 213 bolnikov (48,3 %) je zaključilo ≥ 6 ciklov in skupno 103 bolniki (23,4 %) so zaključili ≥ 10 ciklov zdravljenja s pemetreksedom.
In clinical studies, patients with creatinine clearance of  45 ml/min required no dose adjustments other than those recommended for all patients.
V kliničnih študijah bolniki z očistkom kreatinina  45 ml/min niso potrebovali prilagajanja odmerkov, razen tistih prilagoditev, ki jih priporočamo za vse bolnike.
Of the randomised patients, 44.9 % had a complete/partial response and 51.9 % had a response of stable disease to pemetrexed plus cisplatin induction.
Izmed naključno izbranih bolnikov jih je 44,9 % doseglo popoln/delen odziv in 51,9 % jih je doseglo odziv stabilne bolezni na pemetreksed in indukcijsko zdravilo cisplatina.
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.
V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7 % bolnikov v kraku s pemetreksedom v primerjavi z 21,7 % v kraku s placebom.
Creatinine elevation Creatinine clearance decreased**
Zelo pogosto Povišan kreatinin Znižan očistek kreatinina**
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.
Okrajšave: ALT = alaninska aminotransferaza; AST = aspartatna aminotransferaza; CTCAE = običajni terminološki kriteriji za neželene učinke; NCI = nacionalni inštitut za rakava obolenja; SGOT = serumska glutamat oksalocetna aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek Okužba vključno s sepso
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Accord.
Če ste bili nedavno cepljeni, prosimo, povejte to zdravniku saj lahko to ob jemanju zdravila Pemetreksed Accord povzroča škodljive učinke.
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.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
aStatistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1,17645 mejo prednosti (p < 0,001).
Rash Alopecia
Srbenje Alopecija
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.
Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik, in običajno naj bi ne presegali 24 ur pri 2 C do 8 C, razen če rekonstitucija/redčenje potekata pri nadzorovanih in potrjeno aseptičnih pogojih.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Accord.
Če se vam okrog pljuč nabira tekočina, se bo zdravnik morda odločil tekočino pred dajanjem zdravila Pemetreksed Accord odstraniti.
Conjunctivitis (inflamed eye)
Konjunktivitis (vnetje očesa)
Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors (see section 4.8).
Večina bolnikov, pri katerih so take dogodke opažali, je imela v preteklosti srčnožilne dejavnike tveganja (glejte poglavje 4.8).
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Accord and should therefore use effective contraception during treatment with Pemetrexed Accord and for up to 6 months afterwards.
Moškim odsvetujemo, da bi v času zdravljenja z zdravilom Pemetreksed Accord ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom Pemetreksed Accord ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
Children and adolescents There is no relevant use of Pemetrexed Accord in the paediatric population
Otroci in mladostniki Zdravilo Pemetreksed Accord ni namenjeno za uporabo pri pediatrični populaciji.
Lower limb swelling with pain and redness Increased urine output
Otekanje spodnjih okončin z bolečino in pordelostjo Povečano izločanje urina
Pancytopenia- combined low counts of white cells, red cells and platelets Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their Pemetrexed Accord therapy.
Pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju z zdravilom Pemetreksed Accord.
The use of Pemetrexed Accord should be avoided during pregnancy.
Uporabi zdravila Pemetreksed Accord med nosečnostjo se izogibamo.
It is a white to either light yellow or greenish-yellow lyophilised powder.
Je bel do bodisi svetlo rumen ali zeleno-rumen liofiliziran prašek.
A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3%, > 6cycles: 6.4 %: p=0.046).
Znatno povečanje pojavnosti nevtropenije stopnje 3/4, ki je lahko povezano s preučevanim zdravilom, so opazili pri dolgotrajnejši izpostavljenosti pemetreksedu (≤ 6 ciklov: 3,3 %, > 6 ciklov: 6,4 %: p=0,046).
5.2 Preclinical safety data
5.3 Predklinični podatki o varnosti
Pemetrexed Accord must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Zdravilo Pemetreksed Accord smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Accord treatment.
Kortikosteroidi: zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z zdravilom Pemetreksed Accord, na dan zdravljenja in na dan po zdravljenju z zdravilom Pemetreksed Accord.
Common SGPT (ALT) elevation SGOT (AST) elevation
Povišanje SGPT (ALT) Povišanje SGOT (AST)
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena obsevanju, in sicer od nekaj dni do več let po obsevanju.
Patients received a median of4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Bolniki so prejeli mediano 4 cikle vzdrževalnega zdravljenja s pemetreksedom in 4 cikle placeba.
75 % of previous dose (both Pemetrexed Accord and cisplatin)
75 % predhodnega odmerka (obeh, zdravila Pemetreksed Accord in cisplatina)
You must contact your doctor immediately if you notice any of the following: Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common).
Če opazite katerega od spodaj naštetih učinkov, morate nemudoma poklicati zdravnika: Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38 ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
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).
Druga zdravila in zdravilo Pemetreksed Accord Prosimo, povejte zdravniku, če jemljete kaka zdravila proti bolečinam ali vnetju (oteklinam), denimo zdravila, imenovana “nesteroidna protivnetna zdravila” (NSAID-i), vključno z zdravili, ki ste jih dobili brez recepta (kot denimo, ibuprofen).
Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Imunsko pogojena hemolitična anemija (propad rdečih krvnih celic, ki ga povzročijo protitelesa) Hepatitis (vnetje jeter)
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 tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije zdravila Pemetreksed Accord.
If patients develop non-haematologic toxicities  Grade 3 (excluding neurotoxicity), Pemetrexed Accord should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Če se pri bolnikih razvijejo nehematološke toksičnosti  stopnje 3 (z izjemo nevrološke toksičnosti), moramo dajanje zdravila Pemetreksed Accord prekiniti, dokler se vrednosti ne povrnejo na manjše ali enake, kot jih je imel bolnik pred zdravljenjem.
In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Študije in vitro so pokazale, da se pemetreksed vede kot večtarčni antifolat z zaviranjem timidilatne sintaze (TS), dihidrofolatne reduktaze (DHFR) in glicinamidne ribonukleotidne formiltransferaze (GARFT), ki so ključni od folata odvisni encimi za de novo biosintezo timidinskih in purinskih nukleotidov.
The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm.
Mediana časa od začetka zdravljenja s pemetreksedom in indukcijskim zdravilom cisplatina do začetka vzdrževalnega zdravljenja je bila 2,96 meseca tako v skupini s pemetreksedom, kot v skupini s placebom.
The separation between the treatment arms was achieved by improvement in lung function in the pemetrexed /cisplatin arm and deterioration of lung function over time in the control arm.
Razlikovanje med vejama zdravljenja je bilo doseženo z izboljšanjem delovanja pljuč v veji zdravljenja s pemetreksedom/cisplatinom in poslabšanjem pljučnega delovanja s časom v kontrolni veji preskušanja.
If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Pemetrexed Accord.
Če imate ali ste imeli težave z ledvicami, se pogovorite z zdravnikom ali bolnišničnim farmacevtom, ker morda ne boste mogli prejeti zdravila Pemetreksed Accord.
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N=519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda (N=281).
If you are concerned about any side effects, talk to your doctor.
Če ste zaradi kateregakoli neželenega učinka (neželenih učinkov) zaskrbljeni, se pogovorite s svojim zdravnikom.
Pemetrexed Accord can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Zdravnik vam lahko predpiše zdravilo Pemetreksed Accord, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
• Obligation to conduct post-authorisation measures Not applicable
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.
You will always receive Pemetrexed Accord by infusion into one of your veins.
Zdravilo Pemetreksed Accord boste vedno prejeli v obliki infuzije v veno.
First line doublet therapy containing pemetrexed was not included.
Dvojne terapije prvega izbora s pemetreksedom niso vključili.
When using Pemetrexed Accord in combination with cisplatin:
Kadar uporabljamo zdravilo Pemetreksed Accord v kombinaciji s cisplatinom:
How to store Pemetrexed Accord Contents of the pack and other information
Shranjevanje zdravila Pemetreksed Accord Vsebina pakiranja in dodatne informacije
Each pack of Pemetrexed Accord consists of one vial.
Vsako pakiranje zdravila Pemetreksed Accord vsebuje eno vialo zdravila Pemetreksed Accord.
Pemetrexed + cisplatin Gemcitabine + cisplatin
Pemetreksed + Cisplatin Gemcitabin + Cisplatin
If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)
Če doživite nenadno težko dihanje, močno bolečino v prsih ali kašelj s krvavim izmečkom (redko) (lahko kaže na krvni strdek v krvnih žilah v pljučih).
Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Zato je pri dajanju visokih odmerkov NSAID-ov ali acetilsalicilne kisline sočasno s pemetreksedom bolnikom z normalnim delovanjem ledvic (očistek kreatinina  80 ml/min) potrebna previdnost.
Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Accord.
Dopolnjevanje vitaminov: zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem zdravila Pemetreksed Accord jemati enkrat dnevno.
Pemetrexed Accord is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Zdravilo Pemetreksed Accord se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Accord powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Bolnišnični farmacevt, medicinska sestra ali zdravnik bo prašek Pemetreksed Accord, preden ga boste prejeli, zmešal z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Accord and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Accord treatment).
V tednu pred dajanjem zdravila Pemetreksed Accord boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom Pemetreksed Accord).
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n= 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Klinično pomembne laboratorijske toksičnosti stopenj 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (n = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12,8 % oziroma 5,3 %) in povišanja alaninske aminotransferaze (15,2 % oziroma 1,9 %).