natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001 Pemetrexed medac 100 mg EU/1/15/1038/002 Pemetrexed medac 500 mg EU/1/15/1038/003 Pemetrexed medac 1,000 mg
EU/1/15/1038/001 Pemetreksed medac 100 mg EU/1/15/1038/002 Pemetreksed medac 500 mg EU/1/15/1038/003 Pemetreksed medac 1000 mg
If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
Če prejemate tudi cisplatin, bo zdravnik zagotovil, da ste ustrezno hidrirani ter da pred prejemanjem cisplatina in po njem prejemate ustrezno zdravljenje za preprečevanje bruhanja;
When using Pemetrexed medac in combination with cisplatin The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Kadar uporabljamo zdravilo Pemetreksed medac v kombinaciji s cisplatinom Zdravnik ali bolnišnični farmacevt bo določil odmerek, ki ga potrebujete, na podlagi vaše telesne višine in mase.
Reconstituted and infusion solutions: The product should be used immediately.
Rekonstituirane raztopine in raztopine za infundiranje: zdravilo moramo uporabiti nemudoma.
In particular, tell your doctor if you are using 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).
Še zlasti je pomembno, da poveste svojemu zdravniku, če jemljete zdravila proti bolečinam ali vnetju (oteklinam), denimo zdravila, imenovana »nesteroidna protivnetna zdravila« (NSAID), vključno z zdravili, ki ste jih dobili brez recepta (npr. ibuprofen).
If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression and gastrointestinal toxicity.
Če je sočasno dajanje NSAID-ov potrebno, je pri bolnikih potrebno skrbno spremljati toksičnost, predvsem mielosupresijo in gastrointestinalno toksičnost.
− you have heart disease or a history of heart disease.
− če imate bolezen srca ali če ste v preteklosti imeli bolezen srca;
Your doctor will discuss with you the potential risk of taking Pemetrexed medac during pregnancy.
Zdravnikom se boste pogovorili o možnem tveganju pri prejemanju zdravila Pemetreksed medac v času nosečnosti.
Patients must also receive an intramuscular injection of vitamin B12 (1,000 µg) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Bolniki morajo prejeti tudi intramuskularno injekcijo vitamina B12 (1000 µg) v tednu pred prvim odmerkom pemetrekseda in enkrat vsake tri cikluse zatem.
Each pack consists of one vial containing 100 , 500 or 1,000 mg of pemetrexed.
Vsako pakiranje vsebuje eno vialo s 100, 500 ali 1000 mg pemetrekseda.
− taste change
− sprememba okusa
Name and address of the manufacturers responsible for batch release Synthon Hispania, S.L.
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Synthon Hispania, S.L.
− loss of appetite
− slabost − izguba apetita
Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Z zdravnikom se posvetujte, kdaj je po koncu zdravljenja varno ponovno začeti dojiti.
− if you have recently received or are about to receive a vaccine against yellow fever.
− če ste bili nedavno cepljeni ali boste kmalu cepljeni proti rumeni mrzlici.
There are many sorts of NSAIDs with different durations of activity.
Obstaja veliko vrst zdravil NSAID z različnimi trajanji delovanja.
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 medac.
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 medac.
− liver: abnormal blood tests
− jetra: nenormalne vrednosti krvnih testov
Vitamin supplementation
Dopolnjevanje vitaminov
− allergic reaction: skin rash / burning or prickling sensation
− alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek
Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for Pemetrexed medac 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 medac, če ga uporabljamo kot edino učinkovino ali v kombinaciji s cisplatinom.
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 indukcijsko terapijo s pemetreksedom in cisplatinom.
Kaplan Meier plots of overall survival by histology
Kaplan Meierjeva grafa skupnega preživetja glede na histologijo
The resulting solution is clear and ranges in colour from colourless to yellow without adversely affecting product quality.
Nastala raztopina je bistra, barve v razponu od brezbarvne do rumene ne vplivajo na kakovost izdelka.
− 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
Concomitant use contraindicated: Yellow fever vaccine: risk of fatal generalised vaccine disease (see section 4.3).
Kontraindicirana sočasna uporaba: Cepivo proti rumeni mrzlici: tveganje za smrtno generalizirano bolezen po cepljenju (glejte poglavje 4.3).
− fever or infection (common): if you have a temperature of 38 °C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
− 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).
Thus, drainage of third space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Zato je pred zdravljenjem s pemetreksedom vredno premisliti o drenaži tekočine tretjega prostora, čeprav to morda ni potrebno.
• HR (95 % CI) Response (n: qualified for response)
• RT (95 % IZ) Odziv (n: ustrezen za odziv)
Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to
Pogostnosti so določene kot: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000
The other ingredients are mannitol, hydrochloric acid and sodium hydroxide, please see section 2 “Pemetrexed medac contains sodium”.
Druge sestavine zdravila so manitol, klorovodikova kislina in natrijev hidroksid; glejte poglavje 2 »Zdravilo Pemetreksed medac vsebuje natrij«.
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.
sta bili 58 % in 32 %, v primerjavi s 45 % in 21 % pri bolnikih, ki so prejemali placebo.
**** Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary - other.
**** Skupni izraz vključuje povišan kreatinin v serumu/krvi, znižano stopnjo glomerulne filtracije, ledvično odpoved in ledvice/sečila - drugo.
• 95 % CI for median
• 95 % IZ za mediano
− fast heart rate
− hiter srčni utrip
− oedema (excess fluid in body tissue, causing swelling)
− edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino)
− hypernatraemia - increased sodium in blood
− hipernatriemija - zvišana raven natrija v krvi
Your doctor will prescribe you steroid tablets (equivalent to 4 mg of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed medac treatment.
Zdravnik vam bo predpisal tablete steroidov (ustrezno 4 mg deksametazona dvakrat dnevno), ki jih boste morali jemati na dan pred zdravljenjem, na dan zdravljenja in na dan po zdravljenju z zdravilom
Treatment with pemetrexed should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Zdravljenje s pemetreksedom moramo prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed medac and should therefore use effective contraception during treatment with Pemetrexed medac and for up to 6 months afterwards.
Moškim odsvetujemo, da bi v času zdravljenja z zdravilom Pemetreksed medac ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom Pemetreksed medac ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
Children and adolescents There is no relevant use of Pemetrexed medac in the paediatric population.
Otroci in mladostniki Zdravilo Pemetreksed medac ni primerno za uporabo pri pediatrični populaciji.
− pancytopenia-combined low counts of white cells, red cells and platelets
− pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov
75 % of previous dose
75 % predhodnega odmerka 75 % predhodnega odmerka
Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
klorovodikova kislina (za uravnavanje vrednosti pH) natrijev hidroksid (za uravnavanje vrednosti pH)
− inflammation of the skin, mainly of the lower limb with swelling, pain and redness
− vnetje kože, večinoma spodnjih okončin, z otekanjem, bolečino in pordelostjo
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Druga zdravila in zdravilo Pemetreksed medac Obvestite zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m² infused over a 10-minute period.
Farmakokinetične lastnosti pemetrekseda po dajanju ene učinkovine so vrednotili pri 426 bolnikih z različnimi malignimi trdnimi tumorji v razponu odmerkov od 0,2 do 838 mg/m², infundiranih v
− you currently have or have previously had problems with your kidneys, as you may not be able to receive Pemetrexed medac.
− če imate ali ste imeli težave z ledvicami, ker morda ne boste mogli prejeti zdravila Pemetreksed medac.
Fisher's exact p-value*
(95 % IZ) Fisherjeva točna p-vrednost*
The use of Pemetrexed medac should be avoided during pregnancy.
Uporabi zdravila Pemetreksed medac med nosečnostjo se izogibamo.
− acute renal failure
− akutna odpoved ledvic
System organ class Frequency Event*
Organski sistem Pogostnost Dogodek*
− low haemoglobin level (anaemia)
− nizka raven hemoglobina (anemija)
− loss of sensation
− izguba občutka
− immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
− imunsko pogojena hemolitična anemija (propad rdečih krvnih celic, ki ga povzročijo protitelesa)
− you have been recently vaccinated, as this can possibly cause bad effects with Pemetrexed medac.
− če ste bili nedavno cepljeni, saj lahko to ob jemanju zdravila Pemetreksed medac povzroča škodljive učinke;
The recommend dose of Pemetrexed medac is 500 mg for every square metre of your body's surface area.
Priporočeni odmerek zdravila Pemetreksed medac je 500 mg za vsak kvadratni meter površine vašega telesa.
08830 Barcelona, Spain
08830 Barcelona, Španija Synthon, s.r.o.
What Pemetrexed medac is and what it is used for What you need to know before you use Pemetrexed medac How to use Pemetrexed medac Possible side effects
Kaj je zdravilo Pemetreksed medac in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed medac Kako uporabljati zdravilo Pemetreksed medac
*** Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N = 663) and PARAMOUNT continuation pemetrexed maintenance (N = 539) studies.
*** Skupna preglednica neželenih učinkov združuje rezultate študij vzdrževalnega zdravljenja samo s pemetreksedom JMEN (N = 663) in nadaljevalnega vzdrževalnega zdravljenja s pemetreksedom (PARAMOUNT: N = 539).
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 * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
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.
− you have an accumulation of fluid around your lungs, as your doctor may decide to remove the fluid before giving you Pemetrexed medac.
− če se vam okoli pljuč nabira tekočina, se bo zdravnik morda odločil tekočino pred dajanjem zdravila Pemetreksed medac odstraniti.
Pemetrexed 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 medac, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
− upset stomach
− bolečina v trebuhu
When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C - 8 °C).
Po pripravi po navodilih so kemijsko in fizikalno obstojnost za uporabo pripravljenih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje pokazali za 24 ur v hladilniku (2 °C - 8 °C).
Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed medac has finished.
Cisplatin tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije zdravila Pemetreksed medac.
Pemetrexed medac.
Pemetreksed medac.
Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size
Okrajšave: IZ = interval zaupanja; RT = razmerje tveganja; NZ = namen zdraviti; n = velikost populacije.
How to store Pemetrexed medac Contents of the pack and other information
Shranjevanje zdravila Pemetreksed medac Vsebina pakiranja in dodatne informacije
A phase 2 study of pemetrexed in 31 solid tumour patients with stable third space fluid demonstrated no difference in pemetrexed dose normalized plasma concentrations or clearance compared to patients without third space fluid collections.
V študiji pemetrekseda so v fazi II pri 31 bolnikih s solidnim tumorjem in stabilno tekočino tretjega prostora pokazali, da ni razlike med koncentracijo v plazmi ali očistkom, normaliziranima glede na odmerek pemetrekseda, v primerjavi z bolniki brez zaloge tekočine tretjega prostora.
Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Bolniki, ki so bili naključno izbrani za vzdrževalno zdravljenje, so morali imeti indeks zmogljivosti po ECOG 0 ali 1.
− pain, redness, swelling or sores in your mouth
− bolečina, rdečina, otekanje ali rane v ustih
These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice s karcinomom dojke, ki so v preteklosti večkrat prejele kemoterapijo, s predhodno obstoječimi metastazami v jetrih in/ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
− 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 (občasno) (lahko kaže na krvni strdek v krvnih žilah v pljučih).
Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm³ and platelets should be ≥ 100,000 cells/mm³.
Pred začetkom kateregakoli ciklusa kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti ≥ 1500 celic/mm³ ter število trombocitov ≥ 100.000 celic/mm³.
The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Profila varnosti vzdrževalnega zdravljenja s pemetreksedom iz obeh študij, JMEN in PARAMOUNT,
You will always receive Pemetrexed medac by infusion into one of your veins.
Zdravilo Pemetreksed medac boste vedno prejeli v obliki infuzije v veno.
A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed medac 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 medac, preden ga boste prejeli, zmešal z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
75 % of previous dose (both pemetrexed and cisplatin)
75 % predhodnega odmerka (pemetrekseda in cisplatina)
Pemetrexed medac must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Zdravilo Pemetreksed medac smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
67801 Blansko Czech Republic Tel.: +420 516 427 311 Fax: +420 516 417 350
Tel.: +420 516 427 311 Faks: +420 516 417 350
Not known (frequency cannot be estimated from the available data)
− anafilaktični šok (huda alergijska reakcija) Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (n = 41) and patients who did not receive previous docetaxel treatment (n = 540).
Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med bolniki, ki so bili predhodno zdravljeni z docetakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z docetakselom (n = 540).
Blood and lymphatic system disorders
Bolezni krvi in limfatične ga sistema
INFORMATION IN BRAILLE <Justification for not including Braille accepted>
<Sprejeta je utemeljitev, da Braillova pisava ni potrebna.>
− conjunctivitis (inflamed eye)
− konjunktivitis (vnetje očesa)
Pemetrexed medac is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetreksed medac se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
The infusion will last approximately 10 minutes.
Infuzija bo trajala približno
This is equivalent to 2.70% of the recommended maximum daily dietary intake of sodium for an adult.
2,70 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
Obvestite zdravnika, če se pojavijo hud izpuščaj, srbenje ali mehurčki (StevensJohnsonov sindrom ali toksična epidermalna nekroliza).
Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) on a daily basis.
Bolniki morajo dnevno jemati peroralno folno kislino ali multivitaminski pripravek, ki jo vsebuje (350 - 1000 µg).
a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding
a Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
* Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
* Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti.
Pemetrexed in combination with cisplatin
Pemetreksed v kombinaciji s cisplatinom
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1,600 mg/day) and acetylsalicylic acid at higher dose (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 80 ml/min) lahko visoki odmerki nesteroidnih protivnetnih zdravil (NSAID-i, denimo, ibuprofen > 1600 mg dnevno) in acetilsalicilna kislina v visokih odmerkih (≥ 1,3 g dnevno) zmanjšajo eliminacijo pemetrekseda in tako lahko povečajo pojavnost neželenih učinkov pemetrekseda.
Pemetrexed medac is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Zdravilo Pemetreksed medac je namenjeno tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen se širi po tem, ko je bila že uporabljena druga začetna kemoterapija.
Pemetrexed has a steady-state volume of distribution of 9 l/m².
Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/m².
− if you have pain, redness, swelling or sores in your mouth (very common)
− Če imate bolečine, rdečino, oteklino ali razjede v ustni votlini (zelo pogosto).
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg vialo, kar v bistvu pomeni ‘brez natrija'.
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
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.> 18.
− if you experience bleeding from the gums, nose or mouth or any bleeding that would not stop reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common)
− Če vam krvavijo dlesni, krvavite iz nosu ali ustne votline, ali se pojavi kakršnakoli krvavitev, ki se noče ustaviti, rdečkasto ali rožnato obarvan urin, nepričakovane podplutbe (ker imate lahko manj trombocitov, kot je normalno, kar je zelo pogosto).
For instructions on reconstitution and dilution of Pemetrexed medac before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila Pemetreksed medac pred dajanjem glejte poglavje 6.6.
− If you have further questions, ask your doctor or pharmacist.
− Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.