natgillin/translations-raw huggingface dataset:
If your doctor considers co-administration of interleukin-2, it will be given twice, by injection under the skin, each time for 5 consecutive days (before and during treatment with Qarziba). 
Če se bo zdravnik odločil za sočasno dajanje interlevkina-2, vam ga bodo dali dvakrat, z injiciranjem pod kožo, vsakokrat po pet zaporednih dni (pred zdravljenjem z zdravilom Qarziba in med njim).
The pharmacokinetics of dinutuximab beta, based on 10-day continuous intravenous infusion of 10 mg/m2/day (equal to a total dose of 100 mg/m2/course) were evaluated in studies 1 and 2. 
Farmakokinetika dinutuksimaba beta je bila na podlagi desetdnevne neprekinjene intravenske infuzije odmerka 10 mg/m2/dan (kar je enako skupnemu odmerku 100 mg/m2/cikel) ocenjena v študijah 1 in 2.
The exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion) is predicted to be similar in subjects with ages less than or equal to 12 years and decreases slightly for older, heavier subjects. 
Predvidena izpostavljenost (Cmax in AUC24h na 1. in 10. dan med desetdnevno infuzijo) naj bi bila podobna pri bolnikih s starostjo, starih 12 let ali manj, in naj bi se nekoliko zmanjševala pri starejših in težjih bolnikih.
It was combined with 13-cis retinoic in most patients and with IL-2 in 307 patients. 
Pri večini bolnikov so zdravljenje kombinirali s 13-cis-retinoidno kislino, pri 307 bolnikih pa z IL-2.
• With continuous infusion, in response to the patient's pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g. to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour). 
• Pri neprekinjeni infuziji je glede na bolnikovo dojemanje bolečine dajanje morfina mogoče prekiniti v petih dneh, tako da postopno zmanjšate hitrost odmerjanja morfina (npr. na 0,02 mg/kg/h, 0,01 mg/kg/h, 0,005 mg/kg/h).
For 8-hour daily infusions, the solution is administered at a rate of approximately 13 mL per hour. 
Za osemurne dnevne infuzije se raztopina daje s hitrostjo približno 13 ml na uro.
A population pharmacokinetic modelling approach was used to investigate the influence of covariates. 
Za preučevanje vpliva sospremenljivk je bil uporabljen pristop modeliranja populacijske farmakokinetike.
Based on the physician's evaluation of the severity of adverse drug reactions to dinutuximab beta, patients may undergo a dose reduction of 50% or a temporary interruption of the infusion. 
Glede na zdravnikovo oceno izraženosti neželenih reakcij na dinutuksimab beta bo pri bolnikih odmerek zdravila morda zmanjšan za 50 % ali pa bo infuzija začasno prekinjena.
Due to their immunosuppressive activity, concomitant treatment with corticosteroids is not recommended within 2 weeks prior to the first treatment course until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions. 
Zaradi njihovega imunosupresivnega delovanja sočasno zdravljenje s kortikosteroidi v dveh tednih pred prvim ciklom zdravljenja do enega tedna po zadnjem ciklu zdravljenja z dinutuksimabom beta ni priporočljivo, razen v primeru življenjsko nevarnih stanj.
It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with dinutuximab beta. 
Priporočljivo je, da ženske v rodni dobi uporabljajo kontracepcijo šest mesecev po prekinitvi zdravljenja z dinutuksimabom beta.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/4.5 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/4,5 ml
It is recommended that treatment for such reactions include prednisolone administered by intravenous bolus, and epinephrine administered by intravenous bolus every 3 to 5 minutes as necessary, according to clinical response. 
Priporoča se, da zdravljenje tovrstnih reakcij vključuje prednizolon, dan v obliki intravenskega bolusa, in adrenalin, dan v obliki intravenskega bolusa, vsakih 3-5 minut, skladno s kliničnim odzivom.
• prolonged grade 2 peripheral motor neuropathy 
• daljša periferna motorična nevropatija stopnje 2,
Dinutuximab beta is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzmes. 
Dinutuksimab beta je beljakovina, katera predvidena presnovna pot je razgraditev v majhne peptide in posamične aminokisline s pomočjo ubikvitarnih proteolitičnih encimov.
• a condition in which some of the small veins in the liver are obstructed (veno-occlusive disease) 
• stanje, pri katerem so nekatere majhne vene v jetrih zamašene (venska okluzivna bolezen)
After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand. 
Po prekinitvi intravenskega dajanja morfina je v primerih hude nevropatske bolečine mogoče po potrebi peroralno dati morfinijev sulfat (od 0,2 to 0,4 mg/kg vsakih 4 do 6 ur).
Cytokine release syndrome frequently manifests itself within minutes to hours of initiating the first infusion and is characterised by systemic symptoms such as fever, hypotension and urticaria. 
Sindrom sproščanja citokinov se običajno pojavi v nekaj minutah ali urah po uvedbi prve infuzije, zanj pa so značilni sistemski simptomi, kot so povišana telesna temperatura, hipotenzija in urtikarija.
Qarziba is used to treat neuroblastoma that has a high risk of coming back after a series of treatments, which include a stem cell transplantation for rebuilding the immune system. 
Zdravilo Qarziba uporabljamo za zdravljenje nevroblastoma, pri katerem obstaja veliko tveganje za njegov ponovni pojav po nizu zdravljenj, ki vključujejo presaditev matičnih celic za ponovno vzpostavitev imunskega sistema.
First-line patients who received autologous stem cell transplantation In study 3, patients with high-risk neuroblastoma were enrolled after they had received induction chemotherapy and achieved at least a partial response, then myeloablative therapy and stem cell transplantation. 
Bolniki prve linije, ki so prejeli avtologno presaditev matičnih celic V študijo 3 so bili bolniki z nevroblastomom z visokim tveganjem vključeni po tem, ko so prejeli indukcijsko kemoterapijo in dosegli vsaj delni odziv, po čemer so prejeli še mieloablacijsko terapijo in presaditev matičnih celic.
Patients are likely to be immunocompromised as a result of prior therapies. 
Bolniki imajo zaradi predhodnih zdravljenj zelo verjetno oslabljen imunski sistem.
Before receiving Qarziba, you will have blood tests to check your liver, lung, renal and bone marrow functions. 
Preden boste prejeli zdravilo Qarziba, bodo pri vas opravili krvne preiskave, s katerimi bodo preverili delovanje vaših jeter, pljuč, ledvic in kostnega mozga.
It is recommended that antihistamine administration be repeated every 4 to 6 hours as required during dinutuximab infusion. 
Priporoča se, da se dajanje antihistaminika med infuzijo dinutuksimaba ponovi vsakih 4-6 ur, kot je potrebno.
Diluted solution (solution for infusion) 
Razredčena raztopina (raztopina za infundiranje)
Clear Type I glass vial (6 mL) with a halobutyl rubber stopper and aluminium flip-off cap, containing a minimum extractable volume of 4.5 mL concentrate for solution for infusion. 
Prozorna viala (6 ml) iz stekla tipa I z zamaškom iz halobutilne gume in aluminijasto zaporko „flipoff“, ki vsebuje najmanjšo ekstraktibilno prostornino 4,5 ml koncentrata za raztopino za infundiranje.
Cytokine release syndrome was also reported in 32% of the patients. 
Pri 32 % bolnikov so poročali tudi o sindromu sproščanja citokinov.
The development of anti-drug antibodies is a class effect of monoclonal chimeric antibodies. 
Razvoj protiteles na zdravilo je učinek skupine monoklonskih himernih protiteles.
The combination of Qarziba with IL-2 increases the risk of adverse drug reactions compared to Qarziba without IL-2, especially for pyrexia (92% vs. 79%), CLS (50% vs. 25%), pain related to dinutuximab beta (75% vs. 63%), hypotension (43% vs. 26%), and peripheral neuropathy (14% vs. 7%), respectively. 
Kombinacija zdravila Qarziba z IL-2 poveča tveganje za pojav neželenih učinkov, v primerjavi z zdravilom Qarziba brez IL-2, še zlasti za pireksijo (92 % v primerjavi z 79 %), CLS (50 % v primerjavi s 25 %), bolečino, povezano z dinutuksimabom beta (75 % v primerjavi s 63 %), hipotenzijo (43 % v primerjavi s 26 %) in periferno nevropatijo (14 % v primerjavi s 7 %).
Anaphylactic reactions may occur as early as within a few minutes of the first infusion with dinutuximab beta and are commonly associated with bronchospasm and urticaria. 
Anafilaktične reakcije se lahko pojavijo že v nekaj minutah po začetku prve infuzije dinutuksimaba beta in so pogosto povezane z bronhospazmom in urtikarijo.
Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of dinutuximab beta therapy and may necessitate emergency treatment. 
Če se pojavijo hude reakcije, povezane z infundiranjem (vključno s CRS), je treba takoj prekiniti zdravljenje z dinutuksimabom beta in po potrebi uvesti nujne ukrepe.
Qarziba has several side effects that may affect your ability to drive and use machines. 
Zdravilo Qarziba ima več neželenih učinkov, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev.
The solution for infusion should be administered via a peripheral or central intravenous line. 
Raztopino za infundiranje je treba dati prek periferne ali centralne intravenske linije.
No non-clinical studies to evaluate the potential of dinutuximab beta to cause carcinogenicity, genotoxicity or developmental and reproductive toxicity have been conducted. 
Neklinične študije za oceno karcinogenega in genotoksičnega potenciala dinutuksimaba beta ter njegovega vpliva na razvoj in reproduktivno toksičnost niso bile izvedene.
In the repeat-dose toxicity studies in Guinea pigs and cynomolgus monkeys, no adverse effects of dinutuximab beta were observed on reproductive organs at exposure levels above clinical levels. 
V študijah toksičnosti pri ponavljajočih odmerkih, opravljenih na morskih prašičkih in javanskih makakih, niso opazili neželenih učinkov dinutuksimaba beta na reproduktivne organe pri ravneh izpostavljenosti, ki so presegale klinične ravni.
The most frequent hypersensitivity reactions included hypotension (39%), urticaria (18%) and bronchospasm (4%). 
Preobčutljivostne reakcije, ki so se pojavljale najpogosteje, so vključevale hipotenzijo (39 %), urtikarijo (18 %) in bronhospazem (4 %).
Pain typically occurs during the first infusion of dinutuximab beta and decreases over the treatment courses. 
Bolečine se tipično pojavijo med prvo infuzijo dinutuksimaba beta in se zmanjšajo v naslednjih ciklih zdravljenja.
Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies'. 
Zdravilo Qarziba vsebuje dinutuksimab beta, ki spada v skupino zdravil, imenovanih „monoklonska protitelesa“.
Other intravenously co-administered agents should be delivered via a separate infusion line. 
Druga zdravila, ki se sočasno dajejo intravensko, je treba dovajati prek ločene infuzijske linije.
Capillary leak syndrome (CLS) 
Sindrom povečane prepustnosti kapilar (CLS)
• dilated pupils or abnormal pupil reactions 
• razširjene zenice ali nenormalne reakcije zenic
For moderate neuropathic pain, oral tramodol may be administered. 
Pri zmerni nevropatski bolečini je mogoče peroralno dati tramadol.
Neurotoxicity associated to dinutuximab beta is likely due to the induction of mechanical allodynia that may be mediated by the reactivity of dinutuximab beta with the GD2 antigen located on the surface of peripheral nerve fibres and myelin. 
Nevrotoksičnost, povezana z dinutuksimabom beta, verjetno nastane zaradi sprožitve mehanske alodinije, ki je lahko posledica reagiranja dinutuksimaba beta z antigenom GD2 na površini perifernih živčnih vlaken in mielina.
For continuous infusions, any medical device suitable for infusion at a rate of 2 mL per hour can be applied, e.g. syringe infusion pumps/infusors, electronic ambulatory infusion pumps. 
Za neprekinjene infuzije je mogoče uporabiti kateri koli medicinski pripomoček, ki je primeren za infundiranje s hitrostjo 2 ml na uro, npr. infuzijske črpalke z brizgo/infuzorje, elektronske ambulantne infuzijske črpalke.
Additionally, in vivo studies demonstrated that dinutuximab beta could suppress liver metastasis in a syngeneic liver metastasis mouse model. 
Poleg tega so študije in vivo pokazale, da lahko dinutuksimab beta zavira jetrne metastaze v singenskem mišjem modelu jetrnih metastaz.
If IL-2 is combined with dinutuximab beta, it should be given as subcutaneous injections for 5 consecutive days twice during each course. 
Če se IL-2 daje v kombinaciji z zdravilom dinutuksimabom beta, ga je treba dati v obliki subkutanih injekcij pet zaporednih dni, dvakrat v vsakem ciklu zdravljenja.
Study 1 N=15 
Študija 1 N = 15
In order to evaluate the long-term survival effect of dinutuximab, the MAH will submit at least 5-year survival data for patients included in studies APN311-202 and APN311-302. 
Imetnik dovoljenja za promet z zdravilom mora za oceno dolgotrajnih učinkov dinutuksimaba na preživetje predložiti podatke o najmanj petletnem preživetju bolnikov, vključenih v študiji APN311-202 in APN311-302.
• leakage from small blood vessels (capillary leak syndrome) Leakage of blood components from small blood vessels may cause rapid swelling in arms, legs and other parts of the body. 
• iztekanje iz kapilar (sindrom povečane prepustnosti kapilar) Uhajanje komponent krvi skozi stene kapilar lahko povzroči hitro otekanje rok, nog in drugih delov telesa.
The patient-specific daily dose of Qarziba is calculated based on body surface area. 
Dnevni odmerek zdravila Qarziba za posameznega bolnika se izračuna na podlagi njegove telesne površine.
Antihistamine premedication (e.g. diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab beta infusion. 
Premedikacijo z antihistaminiki (npr. difenhidraminom) je treba dati v obliki intravenske injekcije približno 20 minut pred začetkom vsake infuzije dinutuksimaba beta.
You may only use Qarziba if your doctor assesses that benefits outweigh risks for a foetus. 
Zdravilo Qarziba lahko uporabljate le, če zdravnik presodi, da koristi zdravila odtehtajo tveganja za plod.
Findings of note included changes (decrease) in thymus weight as well as bone marrow changes (atrophy affecting myeloid and erythroid precursor cell lines). 
Pomembna odkritja so vključevala spremembe (zmanjšanje) mase priželjca in spremembe kostnega mozga (atrofija, ki vpliva na mieloidne in eritroidne prekurzorske celične linije).
Other frequent adverse reactions were hypersensitivity (63%), vomiting (57%), diarrhoea (51%), capillary leak syndrome (40%) and hypotension (39%). 
Drugi pogosti neželeni učinki so bili preobčutljivost (63 %), bruhanje (57 %), driska (51 %), sindrom kapilarnega prepuščanja (40 %) in hipotenzija (39 %).
Dinutuximab beta has been administered to male and female juvenile Guinea pigs, as well as male and female young cynomolgus monkeys, as repeat-dose regimens that exceeded the recommended clinical dose. 
Dinutuksimab beta so dajali nedoraslim samcem in samicam morskih prašičkov in mladim samcem in samicam javanskih makakov v ponavljajočih odmerkih, ki so presegali priporočeni klinični odmerek.
• The other ingredients are histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid (for pH adjustment). 
• Druge sestavine zdravila so histidin, saharoza, polisorbat 20, voda za injekcije, klorovodikova kislina (za uravnavanje pH).
For continuous infusions, the solution is administered at a rate of 2 mL per hour (48 mL per day) using an infusion pump. 
Za neprekinjene infuzije se raztopina daje s hitrostjo 2 ml na uro (48 ml na dan) z infuzijsko črpalko.
• Before initiation of a continuous intravenous morphine infusion, a bolus infusion of 0.02 to 0.05 mg/kg/hour morphine should be started 2 hours before dinutuximab beta infusion. 
• Pred uvedbo neprekinjene intravenske infuzije morfina je treba začeti z bolusno infuzijo morfina 0,02 do 0,05 mg/kg/h dve uri pred infundiranjem dinutuksimaba beta.
Concomitant use of intravenous immunoglobulins is not recommended as they may interfere with dinutuximab beta-dependent cellular cytotoxicity. 
Sočasna uporaba intravenskih imunoglobulinov ni priporočljiva, saj lahko vplivajo na od dinutuksimaba beta odvisno celično citotoksičnost.
• grade 3 or 4 anaphylaxis 
• anafilaksija stopnje 3 ali 4,
Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. 
Zdravilo Qarziba je indicirano za zdravljenje nevroblastoma z visokim tveganjem pri bolnikih, starih 12 mesecev in več, ki so že prejeli indukcijsko kemoterapijo in dosegli vsaj delni odziv, po katerem so prejeli še mieloablacijsko terapijo in presaditev matičnih celic, in pri bolnikih z recidivnim ali neodzivnim nevroblastomom v anamnezi, z rezidualno boleznijo ali brez nje.
• Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with dinutuximab beta infusion. 
• Nato je priporočljiva hitrost odmerjanja 0,03 mg/kg/h, sočasno z infuzijo dinutuksimaba beta.
Oral gabapentin should be tapered off after weaning off intravenous morphine infusion, at the latest after dinutuximab beta infusion therapy has stopped. 
Peroralni odmerek gabapentina je treba po prekinitvi intravenske infuzije morfina postopoma ukiniti, najkasneje po zaključku zdravljenja z infuzijo dinutuksimaba beta.
Most commonly, patients reported abdominal pain, pain in the extremities, back pain, chest pain, or arthralgia. 
Bolniki so najpogosteje poročali o bolečini v trebuhu, bolečini v okončinah, bolečini v hrbtu, bolečini v prsnem košu in artralgiji.
• With daily infusions of dinutuximab beta, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of dinutuximab beta infusion. 
• Ob dnevnih infuzijah dinutuksimaba beta je treba infundiranje morfina nadaljevati z zmanjšano hitrostjo (npr. 0,01 mg/kg/h) še štiri ure po zaključku infuzije dinutuksimaba beta.
For patients without evidence of disease at baseline, addition of IL-2 did not improve EFS and OS. 
Pri bolnikih brez dokazov o bolezni v izhodišču dodajanje IL-2 ni izboljšalo preživetja brez dogodka in skupnega preživetja.
• paralysis of eye muscles, blurred vision, light sensitivity, swelling in the retina 
• paraliza očesnih mišic, zamegljen vid, občutljivost na svetlobo, otekanje v mrežnici
The patient should be primed with 10 mg/kg/day, starting 3 days prior to dinutuximab beta infusion. 
Bolnike je treba pripraviti z odmerkom 10 mg/kg/dan, ki ga začnemo dajati tri dni pred infuzijo dinutuksimaba beta.
The daily dose of gabapentin is increased to 2×10 mg/kg/day orally, the next day and to 3×10 mg/kg/day orally, the day before the onset of dinutuximab beta infusion and thereafter. 
Dnevni odmerek gabapentina se naslednji dan poveča na 2 × 10 mg/kg/dan peroralno, dan pred prvo infuzijo dinutuksimaba beta in naslednje dni pa na 3 × 10 mg/kg/dan peroralno.
Efficacy without IL-2 N=104 
Učinkovitost brez IL-2 N = 104
• adequate bone marrow function: absolute neutrophil count ≥ 500/µL, platelet count 
• ustrezna funkcija kostnega mozga: absolutno število nevtrofilcev ≥ 500/µl, število trombocitov
Dinutuximab beta was administered at a dose of 20 mg/m2/day on 5 consecutive days, given by 8-hour intravenous infusion in a 5-week treatment course, and was combined with 13-cis-RA and with or without additional subcutaneous IL-2 at the same posologies as in the previous studies. 
Dinutuksimab beta so dajali v odmerku 20 mg/m2/dan pet zaporednih dni, z osemurno intravensko infuzijo v pettedenskem ciklu zdravljenja, in so ga kombinirali s 13-cis-RA in z dodatnim subkutanim IL-2 ali brez njega v enakih odmerjanjih kot v prejšnjih študijah.
Do not perform these activities if your ability to concentrate and react is affected. 
Če se pri vas pojavijo učinki na vašo sposobnost koncentracije in reagiranja, ne upravljajte vozil in strojev.
• For continuous infusions, the solution for infusion can be prepared freshly on a daily basis, or sufficient for up to 5 days of continuous infusion. 
• Za neprekinjene infuzije je mogoče svežo raztopino za infundiranje pripraviti vsakodnevno ali pa v količini, ki zadošča za največ pet dni neprekinjenega infundiranja.
In animals, dedicated fertility studies have not been conducted, but no adverse effects on reproductive organs were observed in toxicity studies performed in Guinea pig and cynomolgous monkey. 
Namenskih študij o plodnosti pri živalih niso izvedli, vendar pa v študijah toksičnosti pri morskih prašičkih in javanskih makakih niso bili opaženi neželeni učinki na reproduktivne organe.
Treatment of hypersensitivity reactions 
Zdravljenje preobčutljivostnih reakcij
In a compassionate use programme (study 1), 54 patients received 10 mg/m2/day dinutuximab beta given by continuous 10-day intravenous infusion in a 5-week treatment course, concurrently with subcutaneous IL-2 (6×106 IU/m²/day given on days 1-5 and 8-12 of each course) and followed by oral 
V programu sočutne uporabe (študija 1) je 54 bolnikov prejemalo odmerek 10 mg/m2/dan dinutuksimaba beta v obliki neprekinjene 10-dnevne intravenske infuzije v pettedenskem ciklu zdravljenja, sočasno s subkutanim IL-2 (6 x 106 i. e./m²/dan, ki so ga prejemali od 1. do 5. dneva in od
These adverse reactions are presented by MedDRA system organ class and frequency. 
Predstavljeni so v skladu z organskimi sistemi in pogostnostjo po sistemu MedDRA.
• rapid swelling of arms, legs and other body parts, rapid drop in blood pressure, light-headedness and breathing difficulties (capillary leak syndrome) 
• hitro otekanje rok, nog in drugih delov telesa, nenaden padec krvnega tlaka, omotičnost in težave z dihanjem (sindrom povečane prepustnosti kapilar)
PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid. 
FARMACEVTSKA OBLIKA Koncentrat za raztopino za infundiranje Prozorna, brezbarvna tekočina.
Other medicines and Qarziba 
Druga zdravila in zdravilo Qarziba
with IL-2 N=76 
z IL-2 N = 76
The efficacy of dinutuximab beta has been evaluated in a randomised controlled trial comparing the administration of dinutuximab beta with or without IL-2 in the first-line treatment of patients with high-risk neuroblastoma and in two single-arm studies in the relapsed/refractory setting. 
Učinkovitost dinutuksimaba beta so ocenjevali v randomiziranem nadzorovanem preskušanju, v katerem so primerjali dajanje dinutuksimaba beta z IL-2 in brez IL-2 v zdravljenju prve linije pri bolnikih z nevroblastomom z visokim tveganjem in v dveh študijah s po eno skupino bolnikov z recidivno/neodzivno boleznijo.
• nerve disorder in the arms and/or legs (with abnormal sensations or weakness), light headedness, trembling, muscle spasms 
• motnja živcev v rokah in/ali nogah (z nenormalnimi občutki ali šibkostjo), vrtoglavica, tresenje,
• increased weight 
• povečana telesna masa
Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100). 
Kategorije pogostnosti so opredeljene: zelo pogosti (≥ 1/10); pogosti
Occurrence of haematologic toxicities has been reported with Qarziba, such as erythropenia, thrombocytopenia or neutropenia. 
Pri zdravljenju z zdravilom Qarziba so poročali o pojavu hematoloških toksičnosti, kot so eritropenija, trombocitopenija ali nevtropenija.
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C (50 mL syringe) and for up to 7 days at 37 ºC (250 mL infusion bag), after cumulative storage in a refrigerator (2 °C - 8 °C) for 72 hours. 
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za obdobje do 48 ur pri temperaturi 25 °C (50-mililitrska brizga) in za obdobje do sedem dni pri temperaturi 37 ºC (250-mililitrska infuzijska vrečka), po skupno 72-urnem shranjevanju v hladilniku (2 °C-8 °C).