FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy in first-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16966) support the use of capecitabine in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab for the first-line treatment of metastatic colorectal cancer.
Croatian: Podaci iz faze III multicentričnog, randomiziranog, kontroliranog kliničkog ispitivanja (NO 16966) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom ili s oksaliplatinom i bevacizumabom u prvoj liniji liječenja metastatskog kolorektalnog karcinoma.
English: For Arm B, the XELIRI regimen used capecitabine 1,000 mg/m² twice daily for 14 days + irinotecan 250 mg/m² on day 1.
Croatian: U skupini B je XELIRI protokol obuhvaćao primjenu kapecitabina u dozi od 1000 mg/m² dvaput dnevno tijekom 14 dana uz primjenu irinotekana u dozi od 250 mg/m² 1. dana.
English: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Croatian: medac GmbH
English: The film-coated tablets are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Croatian: Kapecitabin medac 150 mg filmom obložene tablete Filmom obložene tablete su duguljaste, bikonveksne tablete svijetle boje breskve, duljine 11,4 mm i širine 5,3 mm, s oznakom ''150'' s jedne strane i bez oznake s druge strane.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (može se javiti u najviše 1 na 10 osoba):
English: Combination treatment consisted of first-line capecitabine (1,000 mg/m² twice daily for 14 days) combined with irinotecan (250 mg/m² on day 1) (XELIRI) and second-line capecitabine (1,000 mg/m² twice daily for 14 days) plus oxaliplatin
Croatian: Kombinirana terapija sastojala se od primjene kapecitabina (1000 mg/m² dvaput dnevno tijekom 14 dana) u kombinaciji s irinotekanom (250 mg/m² 1. dana) (XELIRI protokol) u prvoj liniji liječenja, a zatim od primjene kapecitabina (1000 mg/m² dvaput dnevno tijekom 14 dana) i oksaliplatina (130 mg/m² 1. dana) u drugoj liniji liječenja.
English: The film-coated tablets are peach coloured, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with ‘500' on one side and plain on other side.
Croatian: Kapecitabin medac 500 mg filmom obložene tablete Filmom obložene tablete su duguljaste, bikonveksne tablete boje breskve, duljine 15,9 mm i širine 8,4 mm, s oznakom ''500'' s jedne strane i bez oznake s druge strane.
English: White to off-white, oblong shaped, biconvex tablet, debossed with ‘300' on the one side and plain on the other side.
Croatian: Tableta bijele do gotovo bijele boje, duguljastog oblika, bikonveksna, s oznakom „300“ na jednoj strani i bez oznake na drugoj strani.
English: INFORMATION IN BRAILLE Capecitabine medac 300 mg
Croatian: Kapecitabin medac 300 mg
English: 7.5 mg/kg intravenous 30 - 90 mins
Croatian: 7,5 mg/kg intravenski
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetko (može se javiti u najviše 1 na 10 000 osoba koje primaju lijek):
English: Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150' on the one side and plain on the other side.
Croatian: Tableta svijetle boje breskve, duguljastog oblika, bikonveksna, s oznakom „150“ na jednoj strani i bez oznake na drugoj strani.
English: Intestinal obstruction, Ascites, Enteritis, Gastritis, Dysphagia, Abdominal pain lower, Oesophagitis, Abdominal discomfort, Gastrooesophageal reflux disease, Colitis, Blood in stool
Croatian: Poremećaji probavnog sustava proljev, povraćanje, mučnina, stomatitis, bol u trbuhu gastrointestinalno krvarenje, konstipacija, bol u gornjem dijelu trbuha, dispepsija, flatulencija, suha usta opstrukcija crijeva, ascites, enteritis, gastritis disfagija, bol u donjem dijelu abdomena, ezofagitis, nelagoda u abdomenu, gastroezofagealni refluks, kolitis, krv u stolici
English: Aluminium/aluminium blisters
Croatian: 6.3 Rok valjanosti Aluminij/aluminij blisteri
English: The median duration of survival was 10.5 months (capecitabine + cisplatin) versus 9.3 months (5-FU + cisplatin).
Croatian: (kombinacija kapecitabina i cisplatina) u odnosu na 9,3 mjeseca (kombinacija 5-FU i cisplatina).
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets Capecitabine medac 300 mg film-coated tablets Capecitabine medac 500 mg film-coated tablets
Croatian: Kapecitabin medac 150 mg filmom obložene tablete Kapecitabin medac 300 mg filmom obložene tablete Kapecitabin medac 500 mg filmom obložene tablete
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464)
Croatian: Kapecitabin medac 300 mg filmom obložene tablete Hipromeloza (E464)
English: INFORMATION IN BRAILLE Capecitabine medac 500 mg
Croatian: Kapecitabin medac 500 mg
English: Data from one multicentre, randomised, controlled phase 3 clinical trial in patients with stage III (Dukes' C) colon cancer supports the use of capecitabine in combination with oxaliplatin (XELOX) for the adjuvant treatment of patients with colon cancer (NO16968 study).
Croatian: Kombinirana terapija u adjuvantnom liječenju karcinoma kolona Podaci iz faze III multicentričnog, randomiziranog kontroliranog kliničkog ispitivanja u bolesnika s karcinomom kolona stadija III (Dukes C) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom (XELOX) u adjuvantnom liječenju bolesnika s karcinomom kolona (ispitivanje NO16968).
English: 600 mg/ m² intravenous 22 hr
Croatian: 400 mg/m², nakon kojeg slijedi 600 mg/m² intravenski 22 sata placebo ili bevacizumab
English: • nerve pain
Croatian: • bol u području živca
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Croatian: Kapecitabin medac 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg kapecitabina.
English: Capecitabine medac 150 mg film-coated tablets Hypromellose (E464)
Croatian: Kapecitabin medac 150 mg filmom obložene tablete Hipromeloza (E464)
English: Capecitabine medac 500 mg film-coated tablets Hypromellose (E464)
Croatian: Kapecitabin medac 500 mg filmom obložene tablete Hipromeloza (E464)
English: Peach coloured, oblong shaped, biconvex tablet, debossed with ‘500' on the one side and plain on the other side.
Croatian: Tableta boje breskve, duguljastog oblika, bikonveksna, s oznakom „500“ na jednoj strani i bez oznake na drugoj strani.
English: Mucosal inflammation, Pain in limb, Pain, Chills, Chest pain, Influenza-like illness, +Fever, Infusion-related reaction, Injection site reaction, Infusion site pain, Injection site pain
Croatian: Opći poremećaji i reakcije na mjestu primjene hiperpireksija, slabost, letargija, osjetljivost na promjene temperature okoline upala sluznica, bol u ekstremitetima, bol, zimica, bol u prsištu, bolest slična gripi, vrućica, reakcije na infuziju, reakcije na mjestu injiciranja, bol na mjestu davanja infuzije, bol na mjestu injiciranja
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine.
Croatian: Kapecitabin medac 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg kapecitabina.
English: Diabetes,
Croatian: letargija,
English: Lacrimation increased, Conjunctivitis, Eye irritation
Croatian: Poremećaji oka pojačano suzenje, konjunktivitis, nadražaj očiju smanjena oštrina vida,
English: Appetite decreased Hypokalaemia, Hyponatraemia,
Croatian: Poremećaji metabolizma i prehrane smanjen apetit hipokalijemija, hiponatrijemija,
English: How to store Capecitabine medac
Croatian: Kako čuvati Kapecitabin medac
English: Combination therapy in second-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16967) support the use of capecitabine in combination with oxaliplatin for the second-line treatment of metastastic colorectal cancer.
Croatian: Podaci iz faze III multicentričnog, randomiziranog, kontroliranog kliničkog ispitivanja (NO 16967) podržavaju primjenu kapecitabina u kombinaciji s oksaliplatinom u drugoj liniji liječenja metastatskog kolorektalnog karcinoma.
English: Musculoskeletal
Croatian: • spazam mišića
English: Insomnia, Depression Confusional state, Panic attack,
Croatian: Psihijatrijski poremećaji nesanica, depresija stanje smetenosti,
English: • skin rash, hair loss (alopecia), skin reddening, dry skin, itching (pruritus), skin discolouration,
Croatian: • osip na koži, gubitak kose (alopecija), crvenilo kože, suha koža, svrbež (pruritus), promjenaboje kože, gubitak kože, upala kože, poremećaji noktiju
English: Capecitabine medac 300 mg film-coated tablets
Croatian: Kapecitabin medac 300 mg filmom obložene tablete
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (može se javiti u najviše 1 na 100 osoba):
English: Vaginal haemorrhage
Croatian: zamagljen vid
English: Capecitabine medac 150 mg film-coated tablets
Croatian: Kapecitabin medac 150 mg filmom obložene tablete
English: Capecitabine medac 500 mg film-coated tablets
Croatian: Kapecitabin medac 500 mg filmom obložene tablete
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose.
Croatian: Kapecitabin medac 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 15 mg bezvodne laktoze.
English: Lipoma
Croatian: Proljev
English: Colon, colorectal and breast cancer
Croatian: Monoterapija Karcinom kolona, kolorektalni karcinom i karcinom dojke
English: The elimination half-life (t1/2 in hours) of capecitabine, 5'-DFCR, 5'-DFUR, 5-FU and FBAL were 0.85, 1.11, 0.66, 0.76 and 3.23 respectively.
Croatian: Eliminacija Poluvrijeme eliminacije (t1/2 u satima) kapecitabina, 5'-DFCR, 5'-DFUR, 5-FU i FBAL iznosilo je
English: Libido decreased
Croatian: depresivno raspoloženje, smanjeni libido
English: Pharyngitis, Oral candidiasis, Influenza, Gastroenteritis, Fungal infection, Infection, Tooth abscess
Croatian: infekcija donjeg dišnog sustava sepsa, infekcija mokraćnog sustava, celulitis, tonzilitis, upala ždrijela, oralna kandidijaza, gripa, gastroenteritis, gljivična infekcija, infekcija, apsces zuba
English: Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Croatian: Jedna 500 mg filmom obložena tableta sadrži 500 mg kapecitabina.
English: Hepatic failure (rare), Cholestatic hepatitis (rare)
Croatian: Poremećaji jetre i žuči hiperbilirubinem ija, odstupanja u testovima jetrene funkcije žutica zatajenje jetre (rijetko), kolestatski hepatitis (rijetko)
English: Oxaliplatin on Day 1, every 3 weeks capecitabine oral twice daily for 2 weeks (followed by 1 week off- treatment)
Croatian: XELOX i bevacizumab oksaliplatin 130 mg/m² intravenski 2 sata oksaliplatin prvog dana, svaka 3 tjedna kapecitabin oralno dvaput dnevno tijekom 2 tjedna (nakon čega slijedi 1
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets capecitabine
Croatian: NAZIV LIJEKA Kapecitabin medac 150 mg filmom obložene tablete kapecitabin
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 300 mg film-coated tablets capecitabine
Croatian: NAZIV LIJEKA Kapecitabin medac 300 mg filmom obložene tablete kapecitabin
English: Dysphagia, Rectal haemorrhage, Abdominal pain lower, Oral dysaesthesia, Paraesthesia oral, Hypoaesthesia oral,
Croatian: usne šupljine, gastritis, distenzija abdomena, gastroezofagealna refluksna bolest, bol u usnoj šupljini, disfagija, rektalno krvarenje, bol u donjem dijelu abdomena, oralna dizestezija, oralna parestezija, oralna hipoestezija, nelagoda u abdomenu
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 500 mg film-coated tablets capecitabine
Croatian: NAZIV LIJEKA Kapecitabin medac 500 mg filmom obložene tablete kapecitabin
English: 5 mg/kg intravenous 30 - 90 mins
Croatian: 5 mg/kg intravenski
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg capecitabine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 300 mg kapecitabina.
English: Capecitabine medac dose calculations
Croatian: Izračuni doze Kapecitabin medac
English: ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, astenija vrućica, periferni edem, malaksalost, bol u prsištu edemi, zimica, bolest slična gripi, tresavica, povišena tjelesna temperatura ** Na temelju iskustva nakon stavljanja lijeka u promet, perzistirajući ili težak sindrom palmarno-plantarne eritrodizestezije može naposljetku dovesti do gubitka otisaka prstiju (vidjeti dio 4.4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg capecitabine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 500 mg kapecitabina.
English: supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
Croatian: Analiza za sekundarna mjera ishoda ispitivanja, preživljenje bez znakova povrata bolesti potvrđuje te rezultate s omjerom hazarda od 0,78 (95 % CI = [0,67; 0,92]; p = 0,0024) za XELOX u odnosu na 5-FU/LV.
English: Capecitabine monotherapy
Croatian: Monoterapija kapecitabinom
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Pharmacare Premium Ltd
English: - ECF: epirubicin (50 mg/ m² as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m² as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m² daily given by continuous infusion via a central line).
Croatian: - ECF: epirubicin (50 mg/m² kao bolus 1. dan, svaka 3 tjedna), cisplatin (60 mg/m² kao dvosatna infuzija 1. dan, svaka 3 tjedna) i 5-FU (200 mg/m² dnevno u obliku kontinuirane infuzije putem centralnog venskog katetera) - ECX: epirubicin (50 mg/m² kao bolus 1. dan, svaka 3 tjedna), cisplatin (60 mg/m² kao dvosatna infuzija 1. dan, svaka 3 tjedna) i kapecitabin (625 mg/m² dvaput dnevno bez pauze) - EOF: epirubicin (50 mg/m² kao bolus 1. dan, svaka 3 tjedna), oksaliplatin (130 mg/m² kao dvosatna infuzija 1. dan, svaka 3 tjedna) i 5-FU (200 mg/m² dnevno u obliku kontinuirane infuzije putem centralnog venskog katetera) - EOX: epirubicin (50 mg/m² kao bolus 1. dan, svaka 3 tjedna), oksaliplatin (130 mg/m² kao dvosatna infuzija 1. dan, svaka 3 tjedna) i kapecitabin (625 mg/m² dvaput dnevno bez pauze)
English: Hydronephrosis, Urinary incontinence, Haematuria, Nocturia, Blood creatinine increased
Croatian: hematurija, noćno mokrenje, porast vrijednosti kreatinina u krvi
English: LIST OF EXCIPIENTS Also contains anhydrous lactose and sodium, read the package leaflet before use.
Croatian: POPIS POMOĆNIH TVARI Također sadrži bezvodnu laktozu i natrij.
English: Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Croatian: Za bolesnike koji primaju kombinaciju kapecitabina i oksaliplatina preporučuje se premedikacija antiemeticima u skladu sa sažetkom opisa svojstava lijeka za oksaliplatin.
English: Musculoskeletal and connective tissue disorders
Croatian: Krvožilni poremećaji tromboflebitis duboka venska tromboza,
English: Depressed mood,
Croatian: napad panike,
English: • abdominal pain
Croatian: • upala vena
English: Faecal excretion is minimal (2.6 %).
Croatian: Stolicom se izluči samo 2,6 %.
English: XELOX + bevacizumab
Croatian: XELOX + bevacizumab (ITT: N = 127)
English: Back pain, Arthralgia pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva bol u mišićima, bol u zglobovima, bol u ekstremitetima bol u čeljusti, spazmi mišića, trizmus, slabost mišića
English: Gastrointestinal haemorrhage, Constipation, Upper abdominal pain, Dyspepsia, Flatulence, Dry mouth
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja grlobolja, dizestezija ždrijela štucavica, faringolaringealna bol, disfonija
English: Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine medac of 1,250 mg/m² and 1,000 mg/m² are provided in tables 1 and 2, respectively.
Croatian: 1250 mg/m² i 1000 mg/m² navedeni su u tablici 1 odnosno tablici 2.
English: Day 1, prior to XELOX, every 3 weeks 5-Fluorouracil: intravenous bolus injection immediately after leucovorin
Croatian: intravenska bolus injekcija odmah nakon leukovorina
English: Joint swelling, Bone
Croatian: BBG 3000, Malta
English: asthma, shortness of breath on exertion
Croatian: nedostatak zraka pri naporu
English: Jaundice
Croatian: povišen
English: Abdominal distension,
Croatian: anemija febrilna neutropenija,
English: Body system Very common
Croatian: Organski sustav
English: (ITT: N = 127)
Croatian: (EPP*: N = 937; ITT**: N = 1017)
English: What Capecitabine medac contains
Croatian: Sadržaj pakiranja i druge informacije Što Kapecitabin medac sadrži
English: Half-life is approximately 30 minutes.
Croatian: Poluvijek iznosi približno 30 minuta.
English: • The importance of maintaining aseptic conditions.
Croatian: • važnost održavanja aseptičkih uvjeta.
English: - if you have any severe condition of the liver.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: • Educational video,
Croatian: • edukacijski video,
English: Final report: 6 years after approval.
Croatian: Konačni izvještaj: 6 godina nakon odobrenja.
English: Other medicines and SCENESSE
Croatian: Drugi lijekovi i SCENESSE
English: Date of latest renewal: 19 November 2019
Croatian: Datum posljednje obnove odobrenja: 19. studenog 2019.
English: Draft protocol to be submitted 2 months after notification of the European Commission decision
Croatian: Nacrt protokola treba dostaviti 2 mjeseca nakon obavijesti o donošenju odluke od strane Europske komisije
English: The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost afamelanotida u djece i adolescenata u dobi od 0 do 17 godina nisu još ustanovljene.
English: There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i njihovom liječenju
English: What you need to know before you receive SCENESSE
Croatian: Što morate znati prije nego počnete primati SCENESSE
English: This effect was observed only at exposure levels approximately 8 times higher than human exposure.
Croatian: Ovaj je učinak zabilježen samo kod razina izloženosti otprilike 8 puta većih od izloženosti u ljudi.
English: One implant is injected every 2 months during the spring and summer months.
Croatian: Jedan implantat se injicira svaka 2 mjeseca tijekom proljetnih i ljetnih mjeseci.
English: A referral to a dermatology specialist might be necessary.
Croatian: Možda će biti potrebno i upućivanje specijalistu dermatologu.
English: However, due to the lack of data caution is warranted.
Croatian: No, zbog nedostatka podataka preporučuje se oprez.
English: The recommended maximum number of implants is four per year.
Croatian: Preporučeni maksimalan broj implantata je četiri godišnje.
English: This finding is not considered relevant to human safety since the Harderian gland is not present in man.
Croatian: Ovaj nalaz se ne smatra relevantnim za sigurnost u ljudi budući da Harderova žlijezda nije prisutna u ljudi.
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been tested in this age group.
Croatian: Ovaj se lijek ne smije primjenjivati u djece i adolescenata mlađih od 18 godina zato što nije ispitan u ovoj dobnoj skupini.
English: At the end of the insertion procedure, you may be able to feel the implant under your skin.
Croatian: Po završetku postupka uvođenja možda ćete moći osjetiti implantat ispod kože.
English: Its binding lasts longer than that of α-MSH.
Croatian: Njegovo vezivanje traje dulje od vremena vezivanja α-MSH.
English: The safety profile is based on pooled data from clinical studies in 425 patients.
Croatian: Sigurnosni profil temelji se na objedinjenim podacima iz kliničkih ispitivanja u 425 bolesnika.
English: What SCENESSE is and what it is used for
Croatian: Što je SCENESSE i za što se koristi
English: Keep in mind that increased exposure to UV light will contribute to skin cancer development.
Croatian: Imajte na umu da povećano izlaganje UV svjetlu doprinosi razvoju raka kože.
English: Please inform your doctor about new or changing skin abnormalities.
Croatian: Obavijestite svog liječnika o novim i promijenjenim abnormalnostima kože.
English: This means that because of the rarity of this disease, for scientific reasons, and for ethical reasons it has been impossible to get complete information on this medicine.
Croatian: To znači da zbog male učestalosti ove bolesti, zbog znanstvenih razloga i zbog etičkih razloga nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: If you have ever had any of these conditions your doctor may have to monitor you more closely during your treatment.
Croatian: Ako ste ikad bolovali od bilo kojeg navedenog stanja, liječnik će Vas možda morati pažljivo pratiti tijekom cijelog liječenja.
English: However, this number should not exceed more than 4 per year.
Croatian: No, ova brojka ne smije premašiti više od 4 implantata godišnje.
English: Tell your doctor if you are taking anticoagulant medicines used to prevent blood clots.
Croatian: Obavijestite svog liječnika ako uzimate antikoagulantne lijekove koji se koriste za sprječavanje zgrušavanja krvi.
English: - if you are allergic to afamelanotide or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na afamelanotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Patients should not drive or use machines in case they are affected by these symptoms.
Croatian: Bolesnici ne smiju upravljati vozilima niti raditi sa strojevima u slučaju da osjete ove simptome.
English: Intermediate reports: annual submission.
Croatian: Međuizvještaji: godišnje podnošenje.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne i razvojne toksičnosti.
English: The registry should collect data from both patients and physicians.
Croatian: U registru se trebaju prikupljati podaci od bolesnika i liječnika.
English: What SCENESSE looks like and contents of the pack
Croatian: Kako SCENESSE izgleda i sadržaj pakiranja
English: The safety of this medicinal product has not been evaluated in clinical trials of duration longer than 2 years (see section 4.2).
Croatian: Sigurnost ovog lijeka nije ocijenjena u kliničkim ispitivanjima trajanja duljeg od 2 godine (vidjeti dio 4.2).
English: Always verify the presence of the implant, if in doubt of its presence, check whether the implant has remained in the catheter.
Croatian: Uvijek provjerite prisutnost implantata, a ako sumnjate u njegovu prisutnost, provjerite je li ostao u kateteru.
English: The second primary objective of the study should be the assessment of the compliance with risk minimization recommendations and the controlled access program for patients receiving SCENESSE.
Croatian: Drugi primarni cilj ispitivanja treba biti ocjena pridržavanja preporuka minimizacije rizika i programa kontroliranog pristupa za bolesnike koji primaju SCENESSE.
English: Because this medicine increases eumelanin, in most treated patients the skin will darken.
Croatian: Budući da ovaj lijek povećava razinu eumelanina, u većine liječenih bolesnika koža će potamniti.
English: Store in a refrigerator (2oC - 8oC).
Croatian: Čuvati u hladnjaku (2oC - 8oC)