natgillin/translations-raw huggingface dataset:
Overall summary of the scientific evaluation of Suifertil 4 mg/ml Oral Solution for Pigs
Splošni povzetek znanstvenega vrednotenja zdravila Suifertil 4 mg/ml peroralna raztopina za prašiče
Grounds for the granting of the marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs
Podlaga za odobritev dovoljenja za promet z zdravilom Suifertil 4 mg/ml peroralna raztopina za prašiče
EU Number
EU (MA) številka Izmišljeno ime
Median time to event (days)
Mediana časa do dogodka (dnevi)
• Take the tablets in the morning and evening as prescribed by your doctor.
• Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
To je pomembno, ker lahko jemanje več zdravil hkrati poveča ali oslabi njihov učinek.
• It is important that you take all your medicine as prescribed by your doctor.
• Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
Ethnic factors
Etnični dejavniki
DPD deficiency
Pomanjkanje DPD
• Fever: if you have a temperature of 38 °C or greater.
• Zvišana telesna temperatura: če imate telesno temperaturo 38 °C ali več.
• Take the tablets within 30 minutes after the end of a meal (breakfast and dinner) and swallow whole with water.
• Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje); tablete pogoltnite cele z vodo.
• if you have a history of eye problems as you may need extra monitoring of your eyes,
• če ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči,
Also, you need to be particularly careful if you are taking any of the following:
Posebno previdni morate biti tudi pri uporabi:
• loss of appetite (anorexia)
• izguba apetita (anoreksija).
DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Pomanjkanje DPD je redko prirojeno stanje, ki navadno ne povzroča težav z zdravjem, razen če prejmete določena zdravila.
• unusual bleeding from the vagina
• neobičajna krvavitev iz vagine,
• blurred or double vision
• zamegljen ali dvojni vid,
LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040 Barcelona
• specific changes in the electrocardiogram (QT prolongation)
• specifične spremembe elektrokardiograma (podaljšanje intervala QT),
Date of latest renewal: 16 June 2017
Datum prve pridobitve dovoljenja za promet: 19. november 2012 Datum zadnjega podaljšanja: 16. junij 2017
Rare/Very rare (Post-marketing experience)
Redki/zelo redki (izkušnje po prihodu zdravila na trg)
• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na kapecitabin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Interrupt until resolved to grade 0-1
1. pojav prekinitev, dokler ni dosežena stopnja 0-1
The AUC of 5-FU was 30 % - 35 % higher on day 14.
AUC 5-FU je bila od 30 do 35 % višja štirinajstega dne.
Capecitabine medac tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Tablete zdravila Kapecitabin medac se običajno jemljejo 14 dni, čemur sledi 7-dnevni premor (ko se tablet ne jemlje).
• if you have brain diseases (for example cancer that has spread to the brain) or nerve damage
• če imate možgansko bolezen (na primer raka, ki se širi v možgane) ali poškodbo živcev
• if you have a severe skin reaction.
• imate hudo kožno reakcijo.
• difficulty speaking, impaired memory, loss of movement coordination, balance disorder,
• težave z govorjenjem, moten spomin, izguba koordinacije gibanja, motnja ravnotežja,
Finally, β-ureido-propionase cleaves FUPA to FBAL which is cleared in the urine.
Na koncu β-ureido-propionaza cepi FUPA v FBAL, ki se izloči z urinom.
** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
** Na podlagi izkušenj po prihodu zdravila na trg lahko vztrajen ali hud sindrom palmarno-plantarne eritrodisestezije sčasoma privede do izgube prstnih odtisov (glejte poglavje 4.4).
The AUC of FBAL increased with age (20 % increase in age results in a 15 % increase in the AUC of FBAL).
AUC za FBAL je z leti naraščala (20 % povečanje v letih daje 15 % povečanje AUC za FBAL).
Parameter: Overall survival
Parameter: Celokupno preživetje
Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet (see section 4 Possible side effects).
Nemudoma obvestite zdravnika, če vas skrbi kateri koli od neželenih učinkov ali če opazite kateri koli dodatni neželeni učinek, ki ni naveden v tem navodilu (glejte poglavje 4 Možni neželeni učinki).
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).
(≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
• inflammation of the skin causing red scaly patches due to an immune system illness
• vnetje kože, ki povzroči rdeče srbeče zaplate zaradi bolezni imunskega sistema.
• difficulty in urination, blood or protein in the urine
• težave pri uriniranju, kri ali beljakovine v urinu,
• ringing or buzzing in the ears (tinnitus), loss of hearing
• zvonjenje ali brnenje v ušesih (tinitus), izguba sluha,
If you take more Capecitabine medac than you should If you take more Capecitabine medac than you should, contact your doctor as soon as possible before taking the next dose.
Če ste vzeli večji odmerek zdravila Kapecitabin medac, kot bi smeli Če ste vzeli večji odmerek zdravila Kapecitabin medac, kot bi smeli, se posvetujte s svojim zdravnikom čim prej, še preden boste zaužili naslednjega.
Capecitabine medac may be used either alone or in combination with other medicines.
Zdravilo Kapecitabin medac se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili.
• Vomiting: if you vomit more than once in a 24-hour time period.
• Bruhanje: če bruhate več kot enkrat v enem dnevu.
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemali katero koli drugo zdravilo.
Persistent or severe HFS (Grade 2 and above) can eventually lead to loss of fingerprints which could impact patient identification.
Vztrajen ali hud sindrom roka-noga (2. stopnje ali višje) lahko sčasoma privede do izgube prstnih odtisov, kar lahko vpliva na identifikacijo bolnika.
• sleeplessness (insomnia), depression
• nespečnost (insomnio), depresija,
The major metabolite excreted in urine is FBAL, which represents 57 % of the administered dose.
Glavni presnovek, ki se izloča z urinom, je FBAL, katerega delež je 57 % zaužitega odmerka.
Careful monitoring of patients ≥ 60 years of age is advisable.
Priporočljivo je skrbno spremljanje bolnikov, starih 60 let ali več.
Severe and/or life-threatening (grade 3 - 4) or considered medically relevant
Občasni Hudi in/ali življenjsko ogrožajoči (stopnja 34) ali klinično pomembni
About 3 % of the administered dose is excreted in urine unchanged.
Približno 3 % kapecitabina se izločijo nespremenjeni.
taste changes
sprememba okusa,
• eye inflammation causing eye pain and possibly eyesight problems
• vnetje oči, ki povzroči boleče oči in morda težave z vidom,
In addition to the above, when Capecitabine medac is used alone, very common side effects which may affect more than 1 in 10 people are:
Poleg zgoraj omenjenih, so lahko, kadar se Kapecitabin medac uporablja samostojno, pri več kot 1 od 10 bolnikov, pojavijo še naslednji zelo pogosti neželeni učinki:
• The active substance is capecitabine.
• Učinkovina je kapecitabin.
5-FU is further catabolised by the enzyme DPD to the much less toxic dihydro-5-fluorouracil (FUH2).
5-FU se nadalje presnovi z encimom DPD v precej manj toksični dihidro-5-fluorouracil (FUH2).
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Adjuvantno zdravljenje bolnikov z rakom kolona stadija III se priporoča 6 mesecev.
• if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
• če se trenutno zdravite ali ste se v preteklih 4 tednih zdravili z brivudinom, ki se uporablja kot del zdravljenja herpes zostra (norice ali pasovec).
Cytochrome P450 2C9 (CYP2C9) substrates
Substrati citokroma P-450 2C9 (CYP2C9)
• allergy
• alergija,
XELOX (PPP*: N = 251; ITT**: N = 313)
XELOX (PPP*: n = 251; ITT**:
Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Navedba smiselno ni potrebna * Glede na skupne kriterije toksičnosti skupine za klinična preskušanja Kanadskega državnega inštituta za raka (NCIC CTG - National Cancer Institute of Canada Clinical Trial Group) (različica 1) ali skupne kriterije za terminologijo neželenih učinkov (CTCAE - Common Terminology Criteria for Adverse Events) programa za vrednotenje zdravljenja raka državnega inštituta za raka ZDA, različica 4.
Creatinine clearance was found to influence the systemic exposure to 5'-DFUR (35 % increase in AUC when creatinine clearance decreases by 50 %) and to FBAL (114 % increase in AUC when creatinine clearance decreases by 50 %).
Kreatininski očistek je vplival na sistemsko izpostavljenost 5'-DFUR (35 % povečanje AUC, kreatininski očistek zmanjšan za 50 %) in FBAL (114 % povečanje AUC in padec kreatinskega očistka za 50 %).
• bruising or reaction at the injection site (caused by medicines given by injection at the same time)
• modrica ali reakcija na mestu injiciranja (ki je posledica injiciranja zdravil na istem mestu).
Capecitabine should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Zdravilo kapecitabinom je treba trajno ukiniti pri bolnikih, pri katerih se med zdravljenjem pojavi huda kožna reakcija.
Furthermore, Capecitabine medac is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery.
Zdravilo Kapecitabin medac se uporablja tudi za preprečevanje novega pojava raka debelega črevesa po kompletni odstranitvi tumorja z operacijo.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
(ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE IMETNIKA DOVOLJENJA
In a pre-planned multivariate Cox analysis, superiority of capecitabine compared with bolus 5-FU/LV was demonstrated.
V vnaprej načrtovani multivariantni Coxovi analizi so dokazali superiornost kapecitabina v primerjavi s 5-FU/LV v obliki bolusa.
Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
Zdravilo kapecitabinom lahko izzove hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
purple spots on the skin
vijolične pike na koži,
The capecitabine pivotal studies included females of childbearing potential and males only if they agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a reasonable period thereafter.
V ključnih študijah s kapecitabin so sodelovale ženske v rodni dobi in moški, če so se strinjali, da bodo uporabljali sprejemljivo metodo kontracepcije, da bi preprečili nosečnost v času študije in primernim obdobjem po njej.
ITT *PPP = per-protocol population; **ITT = intent-to-treat population.
*PPP = populacija po protokolu (per-protocol population); **ITT = populacija, ki so jo nameravali zdraviti (intent-to-treat population).
At the end of treatment, 37 % of patients in the XELIRI and 26 % of patients in the FOLFIRI arm were without evidence of the disease (p = 0.56).
Na koncu zdravljenja je bilo 37 % bolnikov v skupini s XELIRI in 26 % bolnikov v skupini s FOLFIRI brez znakov bolezni (p = 0,56).
Discontinue permanently or If physician deems it to be in the patient's best interest to continue, interrupt until resolved to grade 0-1
- 1. pojav dokončna prekinitev zdravljenja ali če zdravnik meni, da je njegovo nadaljevanje najboljše za bolnika, prekinitev, dokler ni dosežena stopnja 0-1
The dose of Capecitabine medac is based on your body surface area.
Odmerek zdravila Kapecitabin medac je določen glede na vašo telesno površino.
• certain types of arrhythmia (including ventricular fibrillation, torsade de pointes, and bradycardia)
• določene vrste aritmij (vključno z ventrikularno fibrilacijo, torsade de pointes in bradikardijo),
Japanese patients had also about 25 % lower Cmax and 34 % lower AUC for FBAL than Caucasian patients.
Japonski bolniki so imeli v primerjavi s kavkaškimi bolniki prav tako približno 25 % nižjo Cmax in 34 % nižjo AUC za FBAL.
The following are the recommended dose modifications for toxicity:
Sledijo priporočila za prilagajanje odmerkov pri toksičnosti.
Other side-effects seen in this setting are the following:
Drugi neželeni učinki v tem okviru so naslednji:
Hazard ratio 95 % CI P value
razmerje ogroženosti 95-% CI p vrednost
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Following grade 3 HFS, subsequent doses of capecitabine should be decreased.
Po pojavu 3. stopnje moramo nadaljnje odmerke zdravila kapecitabina zmanjšati.
For hand-foot syndrome (HFS) and hyperbilirubinaemia, see section 4.4.
Za sindrom roka-noga in hiperbilirubinemijo glejte poglavje 4.4.
Following oral administration of 825 mg/m² capecitabine twice daily for 14 days, Japanese patients (n = 18) had about 36 % lower Cmax and 24 % lower AUC for capecitabine than Caucasian patients (n = 22).
Po peroralnem dajanju 825 mg/m² kapecitabina dvakrat na dan 14 dni so japonski bolniki (n = 18) imeli približno 36 % nižjo Cmax in 24 % nižjo AUC kapecitabina kakor kavkaški bolniki (n = 22).
However this was associated with an increased incidence of gastrointestinal toxicity and neutropenia during first-line treatment with XELIRI (26 % and 11 % for XELIRI and first line capecitabine respectively).
To pa je bilo povezano s povečano incidenco gastrointestinalnih toksičnosti in nevtropenije med zdravljenjem s shemo XELIRI v prvi liniji (26 % za XELIRI in 11 % za kapecitabin v prvi liniji).
For patients 60 years of age or more, a starting dose reduction of capecitabine to 75 % (950 mg/m² twice daily) is recommended.
Za bolnike, stare 60 let ali več, je priporočljivo začetni odmerek kapecitabina zmanjšati na 75 % (950 mg/m² dvakrat na dan).
(neuropathy),
(nevropatija),
In this trial, 1,002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
V tem preskušanju sta bila 1.002 bolnika randomizirana v eno od naslednjih štirih skupin po 2 x 2 faktorskem načrtu:
The European Medicines Agency has waived the obligation to conduct studies with capecitabine in all subsets of the paediatric population in adenocarcinoma of the colon and rectum, gastric adenocarcinoma and breast carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za izvedbo študij z kapecitabinom za vse podskupine pediatrične populacije z adenokarcinomom kolona in rektuma, želodčnim adenokarcinomom in rakom dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
HR (97.5 % CI)
Razmerje ogroženosti (97,5 % CI)
For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjustment according to toxicity.
Bolnike z delnim pomanjkanjem DPD (kot so tisti s heterozigotnimi mutacijami v genu DPYD) za katere smatramo, da koristi kapecitabina odtehtajo tveganja (upoštevaje primernost druge ne-fluoropirimidinske sheme kemoterapije), je treba zdraviti izredno previdno in jih pogosto spremljati ter prilagoditi odmerek glede na toksičnost.
Number of 150 mg tablets, 300 mg tablets and/or 500 mg tablets per administration (each administration to be given morning and evening)
Število 150 mg tablet, 300 mg tablet in/ali 500 mg tablet za posamezno dajanje (zdravilo se daje zjutraj in zvečer)
The pooled analysis includes 3,097 patients treated with capecitabine-containing regimens and 3,074 patients treated with 5-FU-containing regimens.
Skupna analiza je zajela 3.097 bolnikov, katerih zdravljenje je vključevalo kapecitabin, in 3.074 bolnikov, katerih zdravljenje je vključevalo 5-FU.
Capecitabine medac with food and drink You should take Capecitabine medac no later than 30 minutes after meals.
Zdravilo Kapecitabin medac skupaj s hrano in pijačo Zdravilo Kapecitabin medac morate vzeti najpozneje 30 minut po obroku.
Doses of capecitabine omitted for toxicity are not replaced.
Opuščenih odmerkov kapecitabin zaradi toksičnosti ne nadomeščamo.
EPP ITT *EPP = eligible patient population; **ITT = intent-to-treat population.
*EPP = primerna populacija bolnikov (eligible patient population); **ITT = populacija bolnikov, ki so jih nameravali zdraviti (intent-to-treat population).
• Stevens-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
• Stevens-Johnsonov sindrom: če dobite boleč rdeč ali škrlaten izpuščaj, ki se širi, ali se začnejo pojavljati mehurji in/ali druge poškodbe na sluznici (npr. v ustih in na ustnicah), še posebno, če ste bili občutljivi na svetlobo ali imeli okužbe dihal (npr. bronhitis) in/ali zvišano telesno temperaturo.
• if you have imbalances of ions in your blood (electrolyte imbalances, seen in tests),
• če imate ionsko neravnovesje v krvi (neravnovesje elektrolitov, razvidno iz preiskav),
• if you have calcium imbalances (seen in blood tests),
• če imate porušeno ravnovesje kalcija (razvidno iz krvnih preiskav),
See also section “Do not take Capecitabine medac”.
Glejte tudi poglavje “Ne jemljite zdravila Kapecitabin medac”.
If you have an unrecognised DPD deficiency and take Capecitabine medac, you are at an increased risk of acute early-onset of severe forms of the side effects listed under section 4 Possible side effects.
Če ne veste, da imate pomanjkanje DPD in vzamete zdravilo Kapecitabin medac, imate večje tveganje za nenaden, zgodnji pojav hudih oblik neželenih učinkov, navedenih v poglavju 4 Možni neželeni učinki.
• problems with liver function (seen in blood tests) and increased blood bilirubin (excreted by the liver)
• težave z delovanjem jeter (razvidno iz krvnih preiskav) in povečan krvni bilorubin (ki ga izločajo jetra).
FOLFOX-4 (PPP*: N = 252; ITT**: N = 314)
FOLFOX-4 (PPP*: n = 252; ITT**:
Modified XELIRI + bevacizumab (ITT: N = 120)
XELIRI + bevacizumab (ITT: n = 120)
• pain or altered/abnormal sensation in the mouth, pain in the jaw
• bolečina ali spremenjen/neobičajen občutek v ustih, bolečina v čeljusti,
Table 9 Key efficacy results for the non-inferiority analysis of study NO16967 PRIMARY ANALYSIS
Glavni rezultati o učinkovitosti za analizo ne-inferiornosti v študiji NO16967 OSNOVNA ANALIZA
If the calculated creatinine clearance decreases during treatment to a value below 30 ml/min, Capecitabine medac should be discontinued.
Če se izračunani kreatininski očistek med zdravljenjem zmanjša pod 30 ml/min, je treba zdravljenje z zdravilom kapecitabin ukiniti.
Hand--foot syndrome
Sindrom roka-noga
In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of capecitabine monotherapy with an incidence of less than 0.1 %.
Poleg neželenih učinkov, opisanih v preglednicah 4 in 5, in na podlagi zgoraj omenjene skupne analize iz kliničnih podatkov o varnosti iz sedmih kliničnih preskušanj, je bila tudi encefalopatija povezana z samostojno uporabo kapecitabina, in sicer z incidenco, manjšo kot 0,1 %.
Overall response rate was 49 % in the XELIRI and 48 % in the FOLFIRI arm (p = 0.76).
Celokupni odgovor je bil 49 % v skupini s XELIRI in 48 % v skupini s FOLFIRI (p = 0,76).
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1,401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Študija je bila sestavljena iz dveh delov: začetnega dela iz dveh skupin, v katerem so 634 bolnikov randomizirali v dve različni skupini zdravljenja, po shemi XELOX ali shemi FOLFOX-4, in poznejšega dela s faktorskim načrtom 2 x 2 v katerem so 1.401 bolnika randomizirali v štiri različne skupine zdravljenja, XELOX in placebo, FOLFOX-4 in placebo, XELOX in bevacizumab ter FOLFOX-4 in bevacizumab.
Care should be exercised when capecitabine is co-administered with 2C9 substrates (e.g. phenytoin).
Previdnost je potrebna, kadar kapecitabin dajemo skupaj s substrati 2C9 (npr. fenitoinom).
The incorporation of 5-FU also leads to inhibition of ribonucleic acid (RNA) and protein synthesis.
Vgraditev 5-FU zavira tudi sintezo ribonukleinske kisline (RNA) in proteinov.
Patients with baseline neutrophil counts of < 1.5 x 109/L and/or thrombocyte counts of < 100 x 109/L should not be treated with capecitabine.
Bolnikov, ki imajo pred zdravljenjem število nevtrofilcev < 1,5 x 109/l in/ali število trombocitov < 100 x 109/l, ne zdravimo s kapecitabinom.
Elderly patients (see section 4.2)
Starejši bolniki (glejte poglavje 4.2)
• confusional state, panic attacks, depressed mood, decreased libido
• stanje zmedenosti, napadi panike, depresivno razpoloženje, zmanjšan libido,
• severe skin reaction such as skin rash, ulceration and blistering which may involve ulcers of the mouth, nose, genitalia, hands, feet and eyes (red and swollen eyes)
• hude kožne reakcije, kot so kožni izpuščaj, razjede in mehurji, ki lahko vključujejo razjede v ustih, nosu, na spolovilih, rokah, nogah in v očeh (rdeče in zatekle oči).
• for the treatment of metastatic colorectal cancer (see section 5.1).
• za zdravljenje metastatske oblike kolorektalnega raka (glejte poglavje 5.1).
• hiccups, change in voice
• kolcanje, sprememba glasu,
• if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil),
• če ste že imeli hujšo reakcijo na zdravljenje s fluoropirimidinom (skupino zdravil proti raku, kot je na primer fluorouracil), obvestite svojega zdravnika,
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46 %) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Na osnovi podatkov populacijske farmakokinetične študije, ki je zajela bolnike z velikim razponom v letih (27 do 86 let) in 234 bolnikov (46 %), starih 65 let ali starejših, so ugotovili, da starost ne vpliva na farmakokinetiko 5'-DFUR in 5-FU.
The median follow up at the time of the primary analyses in the intentto-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in table 9.
Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 2,1 leta; podatki iz analize po dodatnih 6 mesecih spremljanja so prav tako vključeni v preglednico 9.