natgillin/translations-raw huggingface dataset:
Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section 
ATE 3. do 4. stopnje so se pojavile pri 1,7 % prejemnikov zdravila ZALTRAP in pri 1,0 % prejemnikov placeba (glejte poglavje
Grade 3-4 VTE occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen and in 6.3 % of patients treated with the placebo/FOLFIRI regimen. 
VTE 3. do 4. stopnje so se pojavili pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 6,3 % prejemnikov sheme placebo/FOLFIRI.
Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months) 
Bolniki, ki predhodno niso bili zdravljeni z bevacizumabom (n (%)) Mediano preživetje brez napredovanja (95 % IZ) (meseci)
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen. 
Krvavitve 3. do 4. stopnje, vključno s krvavitvami v prebavilih, hematurijo in krvavitvami po posegih, so bile opisane pri 2,9 % prejemnikov sheme ZALTRAP/FOLFIRI in 1,7 % prejemnikov sheme placebo/FOLFIRI.
Fistula formation 
Nastanek fistule
Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4). 
Perforacija prebavil 3. do 4. stopnje se je pojavila pri 0,8 % prejemnikov zdravila ZALTRAP in pri 0,2 % prejemnikov placeba (glejte poglavje 4.4).
In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI. 
V ključni študiji pri bolnikih z mKRR so drisko (vseh stopenj) zabeležili pri 69,2 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,5 % prejemnikov sheme placebo/FOLFIRI.
No metabolism studies have been conducted with aflibercept since it is a protein. 
Ker je aflibercept beljakovina, z njim niso izvedli študij presnove.
The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study. 
Od teh bolnikov jih je v študiji III. faze 611 prejemalo 4 mg/kg zdravila ZALTRAP vsaka dva tedna (en ciklus), 605 bolnikov pa kombinacijo placebo/FOLFIRI.
GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP. 
Pri prejemnikih zdravila ZALTRAP so bile opisane perforacije prebavil, vključno s smrtnim izidom.
Arterial thromboembolism (1) Venous thromboembolism (1) 
Pogosti arterijska trombembolija (1) venska trombembolija (1)
What ZALTRAP contains 
Kaj vsebuje zdravilo ZALTRAP
An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 
Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI so zabeležili večje tveganje za hipertenzijo 3. do 4. stopnje (vključno s hipertenzijo in enim primerom esencialne hipertenzije) (glejte poglavje
Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1) 
arterijska trombembolija (1) venska trombembolija (1) krvavitev (1)
Talk to your doctor before being given this medicine if you are breast-feeding. 
Če dojite, se posvetujte s svojim zdravnikom, preden dobite to zdravilo.
Grade 3-4 dehydration was reported in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.3 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4). 
Dehidracijo 3. do 4. stopnje so zabeležili pri 4,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,3 % prejemnikov sheme placebo/FOLFIRI (glejte poglavje 4.4).
Infections and infestations Very common 
Infekcijske in parazitske bolezni Zelo pogosti okužba (1)
Grade 3-4 proteinuria occurred in 7.9 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.2 % of patients treated with the placebo/FOLFIRI regimen. 
Proteinurija 3. do 4. stopnje se je pojavila pri 7,9 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 1,2 % prejemnikov sheme placebo/FOLFIRI.
Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased. 
Pri bolnikih, zdravljenih z zdravilom ZALTRAP, so poročali o srčnem popuščanju in zmanjšanem iztisnem deležu.
Hazard ratio (95 % CI) 
Razmerje ogroženosti (95 % IZ)
Grade 3-4 compromised wound healing occurred in 0.2 % of patients treated with ZALTRAP and none of patients treated with placebo (see section 4.4). 
Slabše celjenje ran 3. do 4. stopnje se je pojavilo pri 0,2 % prejemnikov zdravila ZALTRAP in pri nobenem prejemniku placeba (glejte poglavje 4.4).
One 8 ml vial of concentrate contains 200 mg aflibercept. 
Ena viala z 8 ml koncentrata vsebuje 200 mg aflibercepta.
An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8). 
Pri bolnikih, zdravljenih z afliberceptom, je opisano večje tveganje za krvavitve, vključno s hudimi krvavitvami in včasih krvavitvami s smrtnim izidom (glejte poglavje 4.8).
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI 
V ključni študiji pri bolnikih z mKRR so fistule (analne, enterovezikalne, enterokutane, kolovaginalne, intestinalne) zabeležili pri 9 od 611 (1,5 %) prejemnikov sheme ZALTRAP/FOLFIRI in pri 3 od 605 (0,5 %) prejemnikov sheme placebo/FOLFIRI.
One 4 ml vial of concentrate contains 100 mg aflibercept. 
Ena viala s 4 ml koncentrata vsebuje 100 mg aflibercepta.
Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4) 
Blage do zmerne preobčutljivostne reakcije na zdravilo ZALTRAP (vključno z zardevanjem, izpuščajem, urtikarijo in srbenjem) (glejte poglavje 4.4)
Grade 3-4 diarrhoea was reported in 19.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 7.8 % of patients treated with the placebo/FOLFIRI regimen. 
Drisko 3. do 4. stopnje so zabeležili pri 19,3 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 7,8 % prejemnikov sheme placebo/FOLFIRI.
GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8). 
Pri bolnikih, zdravljenih z afliberceptom, so bile opisane perforacije prebavil, vključno s smrtnim izidom (glejte poglavje 4.8).
In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen. 
V ključni študiji pri bolnikih z mKRR so krvavitve (vseh stopenj) zabeležili pri 37,8 % prejemnikov sheme ZALTRAP/FOLFIRI in 19,0 % prejemnikov sheme placebo/FOLFIRI.
Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP. 
Bolnikom, ki doživijo srčno popuščanje in zmanjšan iztisni delež, prekinite zdravljenje z zdravilom ZALTRAP.
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI. 
V ključni študiji pri bolnikih z mKRR so nevtropenijo (vseh stopenj) zabeležili pri 67,8 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 56,3 % prejemnikov sheme placebo/FOLFIRI.
Grade 3-4 GI perforation events occurred in all 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and in 2 patients (0.3 %) treated with the placebo/FOLFIRI regimen. 
Perforacija prebavil 3. do 4. stopnje se je pojavila pri 3 (0,5 %) prejemnikih sheme placebo/FOLFIRI in pri 2 (0,3 %) prejemnikih sheme placebo/FOLFIRI.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Enoodmerna viala
An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients receiving the ZALTRAP/FOLFIRI regimen. 
Pri prejemnikih sheme ZALTRAP/FOLFIRI so zabeležili večje tveganje za hipertenzijo 3. do 4. stopnje (vključno s hipertenzijo in enim primerom esencialne hipertenzije.
A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8). 
Med zdravljenjem s shemo ZALTRAP/FOLFIRI so opažali večjo incidenco nevtropeničnih zapletov (febrilne nevtropenije in nevtropeničnih okužb) (glejte poglavje 4.8).
Aflibercept administration resulted in a delay in wound healing in rabbits. 
Uporaba aflibercepta je pri kuncih upočasnila celjenje ran.
Stratified on ECOG performance status (0 versus 1 versus 2) and prior bevacizumab (yes versus no). 
Vrednost p za stratificirani Cochran-MantelHaenszelov test a Stratificiran glede na stanje zmogljivosti po ECOG (0 v primerjavi z 1 v primerjavi z 2) in predhodni bevacizumab (da v primerjavi z ne).
Grade 3-4 neutropenia was observed in 36.7 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 29.5 % patients treated with the placebo/FOLFIRI regimen. 
Nevtropenija 3. do 4. stopnje se je pojavila pri 36,7 % prejemnikov sheme ZALTRAP/FOLFIRI in pri 29,5 % prejemnikov sheme placebo/FOLFIRI.
Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8). 
Bolnikom, zdravljenim z afliberceptom, so se pojavile fistule na gastrointestinalnih in negastrointestinalnih mestih (glejte poglavje 4.8).
Oropharyngeal pain Rhinorrhoea 
Pogosti orofaringealna bolečina rinoreja
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen. 
V ključni študiji pri bolnikih z mKRR so slabše celjenje ran zabeležili pri 3 (0,5 %) prejemnikih sheme ZALTRAP/FOLFIRI in pri 5 (0,8 %) prejemnikih sheme placebo/FOLFIRI.
Hypertension (1) Haemorrhage (1) 
Žilne bolezni Zelo pogosti hipertenzija (1) krvavitev (1)
ZALTRAP 25 mg/ml concentrate for solution for infusion 
IME ZDRAVILA ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje
Median overall survival (95 % CI) (months) 
Mediano celokupno preživetje (95 % IZ)
Batch 
PFSb
One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 4 ml viala vsebuje 100 mg aflibercepta (25mg/ml).
VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8). 
Pri bolnikih, ki so prejemali aflibercept, so zabeležili venske trombembolične dogodke (VTE - venous thromboembolic events), vključno z globoko vensko trombozo (GVT) in pljučno embolijo (v redkih primerih s smrtnim izidom) (glejte poglavje 4.8).
Compromised wound healing (1) 
slabše celjenje ran (1)
Urinary tract infection 
Sindrom posteriorne reverzibilne encefalopatije
ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours. 
Zdravljenje z zdravilom ZALTRAP je treba prekiniti, če ima bolnik proteinurijo ≥ 2 grama na 24 ur, in ga znova uvesti, ko se proteinurija zmanjša na < 2 g na 24 ur.
Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10 
Uporabo kombinacije ZALTRAP/FOLFIRI je treba odložiti, dokler ni število trombocitov  75 x 109/l (glejte poglavje 4.2).
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of GI perforation (all grades) was 0.8 % for patients treated with ZALTRAP and 0.3 % for patients treated with placebo. 
V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca perforacij prebavil (vseh stopenj) 0,8 % med prejemniki zdravila ZALTRAP in 0,3 % med prejemniki placeba.
Palmar-Plantar Erythrodysaesthesia syndrome 
Pogosti hiperpigmentiranost kože sindrom palmarno-plantarne eritrodizestezije
Tell your doctor and dentist immediately if you experience such symptoms while being treated with ZALTRAP or after stopping treatment. 
Svojemu zdravniku ali medicinski sestri morate nemudoma povedati, če imate med infundiranjem zdravila ZALTRAP ali kmalu po njem katerega od teh znakov.
Gastrointestinal perforation 
• perforacije prebavil
Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2) 
Bolezni krvi in limfatičnega sistema Zelo pogosti levkopenija (2) nevtropenija (1) trombocitopenija (2)
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of VTE (all grades) was 7.1 % for patients treated with ZALTRAP and 7.1 % for patients treated with placebo. 
V vseh treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca VTE (vseh stopenj) 7,1 % med prejemniki zdravila ZALTRAP in 7,1 % med prejemniki placeba.
Aflibercept treatment should be discontinued in patients who develop nephrotic syndrome or TMA (see section 4.2). 
Pri bolnikih, ki se jim pojavi nefrotski sindrom ali TMA, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles. 
V naslednjih ciklusih velja razmisliti o predhodni uporabi kortikosteroidov in/ali antihistaminikov.
Hepatic impairment 
Pogosti glavobol
Patients with prior bevacizumab (n (%)) 
OS Bolniki, predhodno zdravljeni z bevacizumabom (n
11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47) 
Mediano celokupno preživetje (95 % IZ) (meseci) 11,7 (9,96 do 13,77) 12,5 (10,78 do 15,47) Razmerje ogroženosti (95 % IZ)
Table 3 - OS and PFS by prior bevacizumab exposure a 
Preglednica 3 - Celokupno preživetje in preživetje brez napredovanja glede na predhodno izpostavljenost bevacizumabua - Populacija ZNZ
What ZALTRAP is and what it is used for What you need to know before you are given ZALTRAP How ZALTRAP is given 
Kaj je zdravilo ZALTRAP in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo ZALTRAP Kako uporabljati zdravilo ZALTRAP Možni neželeni učinki
Musculoskeletal and connective tissue disorders Uncommon 
Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni osteonekroza čeljustnic (ONČ)
Metabolism and nutrition disorders Very common 
Presnovne in prehranske motnje Zelo pogosti zmanjšanje apetita hujšanje
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of ATE (all grades) was 2.3 % for patients treated with ZALTRAP and 1.7 % for patients treated with placebo. 
V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca ATE (vseh stopenj) med prejemniki zdravila ZALTRAP 2,3 % in med prejemniki placeba 1,7 %.
Haemorrhage 
• hujšanje
• 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. 
• 8 ml koncentrata v 10-ml viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.
In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4). 
Sindrom posteriorne reverzibilne encefalopatije (PRES) V ključni študiji III. faze pri bolnikih mKRR niso zabeležili primerov PRES. PRES je bil opisan pri bolnikih, ki so prejemali monoterapijo z zdravilom ZALTRAP (0,5 %) in v kombinaciji z drugimi kemoterapijami (glejte poglavje 4.4).
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for patients treated with ZALTRAP and 0.2 % for patients treated with placebo. 
V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca fistul (vseh stopenj) med prejemniki zdravila ZALTRAP 1,1 % in med prejemniki placeba 0,2 %.
• 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. 
• 8 ml koncentrata v 10-ml enoodmerni viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.
Cardiac failure 
Srčne bolezni Občasni srčno popuščanje
Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2). 
Pri bolnikih, ki se jim pojavi fistula, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
• 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc. 
• 4 ml koncentrata v 5-ml enoodmerni viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.
Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache 
Pogosti krvavitev iz danke fistula (1) aftozni stomatitis hemoroidi proktalgija zobobol bolečine v trebuhu bolečine v zgornjem delu trebuha
A higher incidence of severe diarrhoea has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8). 
Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI, so opažali večjo incidenco hude driske (glejte poglavje 4.8).
General disorders and administration site conditions Very common 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti astenična stanja astenična stanja
Skin and subcutaneous tissue disorders Very common 
Bolezni kože in podkožja Zelo pogosti sindrom palmarno-plantarne eritrodizestezije
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients treated with placebo. 
V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca slabšega celjenja ran (vseh stopenj) med prejemniki zdravila ZALTRAP 0,5 % in med prejemniki placeba 0,4 %.
Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4). 
Pri enem prejemniku sheme ZALTRAP/FOLFIRI, ki je imel proteinurijo in hipertenzijo, so postavili diagnozo trombotične mikroangiopatije (TMA) V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca nefrotskega sindroma med prejemniki zdravila ZALTRAP 0,5 % in med prejemniki placeba 0,1 % (glejte poglavje 4.4).
Aflibercept treatment should be discontinued in patients who experience GI perforation (see section 4.2). 
Pri bolnikih, ki se jim pojavi perforacija prebavil, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
Grade 3 compromised wound healing was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the patients treated with the placebo/FOLFIRI regimen. 
Slabše celjenje ran 3. stopnje se je pojavilo pri 2 (0,3 %) prejemnikih sheme ZALTRAP/FOLFIRI, med prejemniki sheme placebo/FOLFIRI pa se ni pojavilo.
Talk to your doctor for advice if you plan to have or father a child. 
Če nameravate zanositi oz. zaploditi otroka, se posvetujte s svojim zdravnikom.
• you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis. 
• če imate bolezni, ki jih spremlja vnetje v prebavilih, na primer divertikulitis, želodčno razjedo ali kolitis- zdravilo ZALTRAP namreč lahko poveča tveganje za predrtje stene prebavil.
Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP. 
Bolnikom, zdravljenim z zdravilom ZALTRAP, so se pojavile fistule na gastrointestinalnih in negastrointestinalnih mestih.
Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4). 
Fistule 3. do 4. stopnje so se pojavile pri 0,2 % prejemnikov zdravila ZALTRAP in pri 0,1 % prejemnikov placeba (glejte poglavje
Dysphonia Oropharyngeal pain 
Občasni dispneja epistaksa disfonija orofaringealna bolečina
Compromised wound healing 
Slabše celjenje ran
Decreased appetite Weight loss 
Redki zmanjšan iztisni delež
Method of administration 
NAČIN UPORABE
Performance status and co-morbidities 
Stanje zmogljivosti bolnika in sočasne bolezni:
Each infusion will take approximately 4 hours. 
Vsaka infuzija traja približno 4 ure.
In addition, an updated RMP should be submitted: 
Poleg tega je treba predložiti posodobljen RMP:
Date of latest renewal: 26 January 2011 
Datum zadnjega podaljšanja: 26. januar 2011
The final study report under this CSP will be submitted by 31 July 2020. 
Končno poročilo o študiji v okviru tega CSP bo predloženo do 31 julija 2020.
There are also links to other websites about rare diseases and treatments. 
Kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Module 5 - Clinical 
Modul 5 - Klinični
If you forget to take this medicine 
Če ste pozabili vzeti to zdravilo
Risk Management Plan 
Načrt obvladovanja tveganja
Your doctor may also give you additional medicines to manage any allergic reactions. 
Zdravnik vam tudi lahko uvede dodatna zdravila za obvladovanje vseh alergičnih reakcij.
Currently available data are described in section 5.1. 
Razpoložljivi podatki so navedeni v poglavju 5.1.
Improved hearing was noted in at least one ear for all four subjects. 
Izboljšan sluh na vsaj enem ušesu je bil zabeležen pri vseh štirih preiskovancih.
Water for injections 
Voda za injekcije.
Genotoxic and carcinogenic potential are not expected. 
Genotoksični in karcinogeni potencial zdravila ni pričakovan.
Unopened vials: 3 years. 
Neodprte viale: 3 leta
Urinary GAG levels decreased by more than 70%, consistent with results in older patients. 
Vrednosti GAG v urinu so se zmanjšale za več kot 70%, kar je skladno z rezultati pri starejših bolnikih.
As a result, these substances do not get broken down and processed by the body as they should. 
Posledica tega je, da telo teh snovi ne razgrajuje in ne presnavlja, kot bi jih moralo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja: 24. januar 2006
The expiry date refers to the last day of that month. 
do: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Substudies will be conducted within the CSP that will: 
V okviru CSP se bodo izvajale podštudije z namenom:
Detailed clinical status information will be collected at study entry and on an annual basis for at least 15 years. 
Podatki o podrobnem kliničnem statusu se bodo zbirali ob vključitvi v študijo in na letni podlagi vsaj 15 let.
What this medicine is and what it is used for 
Kaj je to zdravilo in za kaj ga uporabljamo
What this medicine is and what it is used for What you need to know before you are given this medicine How this medicine is given 
Kaj je to zdravilo in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli to zdravilo Kako se daje to zdravilo
- If you have an allergic reaction your doctor may slow down, or stop, your infusion. 
- Če imate alergijsko reakcijo, lahko vaš zdravnik upočasni ali prekine infuzijo.