natgillin/translations-raw huggingface dataset:
Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Zdravilo Unituxin je indicirano za zdravljenje nevroblastoma z visokim tveganjem pri bolnikih, starih od 12 mesecev do 17 let, ki so že prejeli indukcijsko kemoterapijo in dosegli vsaj delni odgovor, po katerem so prejeli še mieloablacijsko terapijo in avtologno presaditev matičnih celic (ASCT- autologous stem cell transplantation).
Capillary leak syndrome Grade 3 (severe) Onset of symptoms
Sindrom kapilarnih razpok Stopnja 3 (resna) Nastop simptomov
As this medicinal product is used in combination with GM-CSF, IL-2, and isotretinoin, it is difficult to ascertain the causal relationship of each adverse reaction to a particular medicinal product.
V kolikor se to zdravilo uporablja v kombinaciji z GM-CSF, IL-2 in izotretinoinom, je težko ugotoviti vzročno povezavo posameznih neželenih učinkov z določenim zdravilom.
It is recommended that treatment for such reactions include hydrocortisone administered by intravenous bolus, and epinephrine administered by intravenous bolus once every 3-5 minutes as necessary according to clinical response.
Priporoča se, da zdravljenje tovrstnih reakcij vključuje hidrokortizon, apliciran v obliki intravenskega bolusa, in epinefrin, apliciran v obliki intravenskega bolusa, vsakih 3-5 minut, kot je treba glede na klinični odgovor.
• If signs and symptoms resolve rapidly with the above measures, dinutuximab infusion may be resumed at a rate of 0.875 mg/m2/h.
• Če znaki in simptomi hitro izginejo po zgornjih ukrepih, se lahko ponovno daje infuzija dinutuksimaba s hitrostjo 0,875 mg/m2/h.
• Resume infusion at the original rate.
• Ponovno vzpostavite prvotno hitrost infuzije.
Atrial fibrillation, ventricular arrhythmia
atrijska fibrilacija, ventrikularna aritmija
Unequal pupils
- neenakomerni zenici
• If blood pressure (BP) remains stable for at least 2 hours, resume GM
• Če krvni tlak ostane stabilen najmanj 2 uri po ponovnem dajanju GM
Non-clinical studies demonstrate that dinutuximab-induced neurotoxicity is likely due to the induction of mechanical allodynia that may be mediated by reactivity of dinutuximab with GD2 antigen located on the surface of peripheral nerve fibres and/or myelin.
Neklinične študije so dokazale, da nevrotoksičnost, ki jo povzroča dinutuksimab, verjetno nastane zaradi sprožitve mehanske alodinije, ki se lahko posreduje prek reaktivnosti dinutuksimab z antigenom GD2 na površini perifernih živčnih vlaken in/ali mielina.
Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Ne uporabljajte tega zdravila, če pred jemanjem opazite katere koli znake kvarjenja ali obarvanje.
It is not recommended to use intravenous immunoglobulin after ASCT.
Uporaba intravenskega imunoglobulina po avtologni presaditvi matičnih celic (ASCT) ni priporočljiva.
(≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Kategorije pogostnosti so navedene kot sledi: zelo pogosti (≥1/10); pogosti ((≥1/100 do <1/10); občasni (≥1/1.000 do <1/100).
The infusion is started at a dose rate of 0.875 mg/m2/h and continued at this rate for 30 minutes; the rate is then increased to 1.75 mg/m2/h and continued at this rate for the remainder of the infusion, if tolerated.
Začetna hitrost infundiranja je 0,875 mg/m2/h in jo je treba obdržati 30 minut, nato je treba povečati hitrost na 1,75 mg/m2/h in nadaljevati pri tej hitrosti preostali del cikla zdravljenja, če ga bolnik prenaša.
This medicine contains less than 1 mmol sodium (23 mg) per dose.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
Refer to section 4.2 for advice on tapering off or discontinuation of this medicinal product.
Za nasvete glede znižanja odmerka ali prekinitve zdravljenja s tem zdravilom glejte poglavje 4.2.
These studies support the current dinutuximab dosing regimen of 17.5 mg/m2/day administered for four consecutive days during five monthly courses.
Te študije podpirajo trenutni režim odmerjanja 17,5 mg/m2/dan, štiri zaporedne dni v petih mesečnih ciklih.
• Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
• Odložite začetek prvega cikla zdravljenja, dokler alanin-aminotransferaza (ALT) ni < 5 x višja od zgornje meje normalnih vrednosti (ULN - upper limit of normal).
6.6 Special precautions for disposal and other handling The exact volume of Unituxin concentrate for solution for infusion required for the patient dose (see section 4.2) must be injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Točen volumen zdravila Unituxin koncentrat za raztopino za infundiranje, potreben za bolnikov odmerek (glejte poglavje 4.2), je treba injicirati v 100 mililitrsko vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
During the last two weeks in each of the six courses, subjects in both the control and the dinutuximab immunotherapy arms were also given oral isotretinoin at a dose of 160 mg/m2/day (given as 80 mg/m2 twice daily).
V zadnjih dveh tednih vsakega od šestih ciklov so bolniki tako v kontrolni skupini kot v skupini imunoterapije z dinutuksimabom peroralno prejemali izotretinoin v odmerku 160 mg/m2/dan (odmerek po 80 mg/m2 dvakrat na dan).
Warnings and precautions
Posebna opozorila in previdnostni ukrepi
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 17.5 mg/5 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 17,5 mg/5 ml
• Unituxin is given as a drip into one of your veins - for about 10 hours each day for four days.
• Zdravilo Unituxin boste jemali v obliki kapalne infuzije v žilo - približno 10 ur na dan, štiri dni.
Unopened vial
Zaprta viala
• Delay initiation of first course until absolute phagocyte count (APC) is at least 1,000/μL.
• Odložite začetek prvega cikla zdravljenja, dokler absolutna vrednost fagocitov (APC - absolute phagocyte count) ni najmanj 1.000/µl.
Like all medicines, this medicine, which is given with GM-CSF, IL-2 and isotretinoin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo, ki se uporablja skupaj z GM-CSF, IL-2 in izotretinoinom, neželene učinke, vendar pa se ti ne pojavijo pri vseh bolnikih.
It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Daje se v kombinaciji z granulocitno-makrofagne kolonije stimulirajočim faktorjem (GMCSF), interleukinom-2 (IL-2) in izotretinoinom.
Grade 4(life-threatening) Onset of symptoms
Stopnja 4 (življenje ogrožajoča) Nastop simptomov
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Če imate katero koli nadaljnje vprašanje v zvezi z uporabo tega zdravila, se posvetujte s svojim zdravnikom ali medicinsko sestro.
Pre-medication should always be considered before starting each infusion.
Pred začetkom posamezne infuzije je treba vedno upoštevati premedikacijo.
• Problems with your nerves - you may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement (peripheral neuropathy).
• Živčne težave - lahko boste občutili odrevenelost, mravljinčenje ali skelenje v dlaneh, stopalih, nogah ali rokah, zmanjšano občutljivost ali oslabelost pri gibanju (periferna nevropatija).
They help the immune system to target certain cells, such as cancer cells, by ‘sticking' to them.
Ta delujejo podobno kot protitelesa, ki jih telo naravno proizvaja in pomagajo imunskemu sistemu ciljati določene celice, kot so na primer rakaste celice, s tem, da se »prilepijo« nanje.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before being given Unituxin.
Če kaj od naštetega velja za vas (ali če ste negotovi), se pred uporabo zdravila Unituxin posvetujte z zdravnikom ali z medicinsko sestro.
Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures (see sections 4.2 and 4.8).
Zdravilo Unituxin je treba ukiniti, če bolečine ni mogoče primerno nadzorovati kljub zmanjšanju hitrosti infuzije in vzpostavitvi vseh podpornih ukrepov (glejte poglavji 4.2 in 4.8).
The clinical study report should be submitted by PASS: In order to better characterise the safety and immunogenicity of Unituxin and its impact on drug exposure, the applicant should conduct and submit the results of a safety study.
PASS: Za lažjo določitev varnosti in imunogenosti zdravila Unituxin ter njegovega vpliva na izpostavljenost zdravlni učinkovini mora predlagatelj voditi in predložiti rezultate varnostne študije.
Grade 3 or 4 Onset of symptoms
Stopnja 3 ali 4 Nastop simptomov
• If it is possible for you to become pregnant and you are not using contraception, talk to your doctor before being given this medicine.
• Če obstaja možnost, da zanosite, in ne uporabljate kontracepcije, se posvetujte s svojim zdravnikom,
Antihistamine premedication (e.g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion.
Premedikacijo z antihistaminiki (npr. hidroksizin ali difenhidramin) je treba izvajati v obliki intravenske injekcije približno 20 minut pred začetkom vsake infuzije dinutuksimaba.
Unituxin is used with three other medicines: - Isotretinoin - GM-CSF - IL-2
Zdravilo Unituxin se uporablja s tremi drugimi zdravili, imenovanimi: - izotretinoin - GM-CSF - IL-2
Epinephrine (adrenaline) and hydrocortisone for intravenous administration should be immediately available at the bedside during administration of dinutuximab to manage life-threatening allergic reactions.
Med dajanjem dinutuksimaba morata biti epinefrin (adrenalin) in hidrokortizon za intravensko dajanje takoj na razpolago ob bolniški postelji za obvladovanje življenjsko nevarnih alergijskih reakcij.
The recommended dose is 17.5 mg/m2.
Običajen odmerek je 17,5 mg/m2.
Following ASCT, 226 subjects were randomly assigned 1:1 to either a standard therapy arm (six courses of isotretinoin) or a dinutuximab immunotherapy arm (five courses of dinutuximab in combination with alternating GM-CSF and IL-2; combined with isotretinoin concurrently for six courses).
Po ASCT je bilo 226 bolnikov randomiziranih v razmerju 1:1 standardni terapevtski skupini (šest ciklov izotretinoina) oz. skupini imunoterapije z dinutuksimabom (pet ciklov dinutuksimaba v kombinaciji izmenično z GM-CSF ali IL-2; kombinirano hkrati z izotretinoinom za šest ciklov).
Unituxin is a cancer medicine that contains the active substance dinutuximab.
Unituxin je zdravilo proti raku, ki vsebuje zdravilno učinkovino dinutuksimab.
Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Značilni simptomi in znaki vključujejo hipotenzijo, splošen edem, ascites, dispnejo, pljučni edem in akutno odpoved ledvic v povezavi s hipoalbuminemijo in hemokoncentracijo.
What Unituxin looks like and contents of the pack
Videz zdravila Unituxin in vsebina pakiranja
• Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. Renal dysfunction
• Odložite začetek cikla zdravljenja, dokler dispneja med mirovanjem ni odpravljena in/ali je periferna nasičenost s kisikom v sobnem zraku najmanj 94 %.
GM-CSF was administered at a dose of 250 μg/m2/day during Courses 1, 3, and 5 and dosed daily for 14 days.
GM-CSF se je dajal v odmerku 250 μg/m2/dan med cikli 1, 3 in 5, dnevno za 14 dni.
What you need to know before you are given Unituxin
Kaj morate vedeti, preden boste uporabili zdravilo Unituxin
Ibuprofen should not be administered if there is evidence of thrombocytopenia, bleeding, or renal dysfunction.
Ibuprofena se ne sme dajati v primeru trombocitopenije, krvavenja ali motenj v delovanju ledvic.
Unituxin should not be administered as an intravenous push or bolus.
Zdravilo Unituxin se ne sme dajati kot intravensko hitro infuzijo ali bolus.
Non-interventional post authorisation safety study (PASS): In order to evaluate the long-term safety outcomes of dinutuximab in high-risk neuroblastoma patients (including central and peripheral nervous system, prevalence of organ dysfunction, long-term effects on growth and endocrine development, hearing loss, cardiac toxicity and survival data) the applicant should conduct and submit the results of a safety registry.
Do datuma tveganjem (vključno s centralnim in perifernim živčnim sistemom, prevladujočim nedelovanjem organov, dolgotrajnimi učinki na rast in endokrini razvoj, izgubo sluha, srčno toksičnostjo in podatki o preživetju), mora predlagatelj voditi in predložiti rezultate registra o varnosti.
Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2.
Zdravilo Unituxin se daje z intravensko infuzijo v petih ciklih zdravljenja z dnevnim odmerkom 17,5 mg/m2.
If tolerated, increase GM-CSF or IL-2 to full dose the next day.
Če ga prenaša, povišajte GM-CSF ali IL-2 do celotnega odmerka naslednji dan.
• If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
• Če ima bolnik metastaze na osrednjem živčnem sistemu, odložite začetek cikla zdravljenja in dajte transfuzijo trombocitov, da se število trombocitov ohrani na najmanj 50.000/µl.
Long-term overall survival was evaluated with 5 years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone.
Dolgoročno splošno preživetje je bilo ocenjeno s petletnim sledenjem po EFS analizi in je dokazalo večje možnosti preživetja pri bolnikih, zdravljenih z imunoterapijo z dinutuksimabom v primerjavi z bolniki, zdravljenimi samo z izotretinoinom.
5.3 Preclinical safety data
5.3 Predklinični podatki o varnosti Splošna toksičnost
Unituxin will be given to you by a doctor or nurse while you are in hospital.
Zdravilo Unituxin vam bo dal zdravnik ali medicinska sestra, ko boste v bolnišnici, v obliki kapalne infuzije v žilo (intravenska infuzija).
• For IL-2 courses, administer IL-2 at 50 % of the dose starting the next day and continue for the remainder of the course.
• Za cikle zdravljenja z IL-2, aplicirajte 50 % odmerka IL-2, začenši z naslednjim dnem in nadaljujte za ostali del cikla.
See section 4 for more information about pain side effects.
Glejte poglavje 4 za dodatne informacije o bolečinah, ki so posledica neželenih učinkov.
Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection.
Bolniki imajo ponavadi centralni venski kateter in situ in zaradi avtologne presaditve matičnih celic je med terapijo oslabljen njihov imunski sistem, zato je tveganje za sistemske okužbe večje.
Laboratory test abnormalities
Nenormalni rezultati laboratorijskih testov
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before being given this medicine.
Nosečnost • Če ste ali mislite, da ste noseči oz. načrtujete zanositev, se posvetujte s svojim zdravnikom ali medicinsko sestro, preden uporabite to zdravilo.
Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat)
Serum sickness
Serumska bolezen
No non-clinical studies to evaluate the potential of dinutuximab to cause carcinogenicity, genotoxicity, or developmental and reproductive toxicity have been conducted.
Neklinične študije za oceno karcinogenega in genotoksičnega potenciala dinutuksimaba, ter vpliva na sposobnost razmnoževanja niso bile izvedene.
• Rapid swelling of the arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties (Capillary Leak Syndrome).
• hitro otekanje rok, nog in drugih delov telesa, nenaden padec krvnega tlaka, omotičnost in težave z dihanjem (sindrom kapilarnih razpok);
• GM-CSF is given as either an injection under the skin or as a drip into one of your veins each day for
• GM-CSF boste prejeli ali kot podkožno injekcijo ali kot kapalno infuzijo v žilo vsak dan, 14 dni.
The 5 year estimates of OS were 74 % for dinutuximab immunotherapy compared to 57 % for isotretinoin alone (log-rank test p = 0.030).
Petletne ocene splošnega preživetja so bile 74 % za imunoterapijo z dinutuksimabom v primerjavi z 57 % za terapijo izključno z izotretinoinom (log-rank test p = 0,030).
Human IgG is known to be secreted in human milk.
Humana protitelesa IgG se izločajo v materino mleko.
These adverse reactions are presented by MedDRA system organ class and frequency.
Ti neželeni učinki so predstavljeni v skladu z organskimi sistemi in pogostnostjo po MedDRA.
Patients should be monitored for signs and symptoms of infusion reactions for 4 hours after the completion of the Unituxin infusion.
Bolnike je treba 4 ure po zaključku infuzije zdravila Unituxin spremljati za znake in simptome infuzijskih reakcij.
Electrolyte abnormalities have been reported in patients who received Unituxin (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Unituxin, so se pojavile nenormalne vrednosti elektrolitov (glejte poglavje 4.8).
Delay initiation of courses 2-6 until ALT is less than 10 times ULN.
Odložite začetek ciklov zdravljenja od 2 do 6, dokler ALT ni < 10 x ULN.
14 days.
mesecev.
Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.
Treba je izvajati podporne ukrepe in spremljati hidracijo, nenormalne vrednosti elektrolitov, hipertenzijo in anemijo.
Unituxin is a clear, colourless solution for infusion, provided in a clear glass vial.
Zdravilo Unituxin je prozorna, brezbarvna raztopina za infundiranje v prozorni stekleni viali.
IL-2 was administered concurrently with dinutuximab as a continuous intravenous infusion for four days during Week 1 of Courses 2 and 4 at a dose of 3.0 MIU/m2/day, and during Week 2 of Courses 2 and 4 at a dose of 4.5 MIU/m2/day.
IL-2 se je dajal istočasno z dinutuksimabom kot stalna intravenska infuzija za štiri dni med 1. tednom ciklov 2 in 4 v odmerku 3.0 M i.e./m2/dan, med 2. tednom ciklov 2 in 4 pa v odmerku 4,5 M i.e./m2/dan.
Analgesics including intravenous opioids should be administered prior to each dose of Unituxin and continued until two hours following completion of Unituxin infusion.
Analgetike, vključno z intravenskimi opioidi, je potrebno dajati pred vsakim odmerkom zdravila Unituxin in se mora z njimi nadaljevati do dve uri po zaključku dajanja zdravila Unituxin.
Interleukin-2 (IL-2): 3 MIU/m 2/day administered by continuous intravenous infusion over 96 hours on Days 1-4 and4.5 MIU/m2/day on Days 8-11.
Interleukin-2 (IL-2): 3 M i.e./m2/dan, aplicirano prek neprekinjene intravenske infuzije v 96 urah od 1. do 4. dne in 4,5 M i.e./m2/dan od 8. do 11. dne.
An opioid, such as morphine sulphate, is recommended to be administered by intravenous infusion prior to each dinutuximab infusion and continued as an intravenous infusion during and until 2 hours after completion of the treatment.
Priporoča se dajanje opioidov kot je morfinijev sulfat v obliki intravenske infuzije pred vsako infuzijo dinutuksimaba in nadaljevanje dajanja intravenske infuzije med terapijo ter do dve uri po zaključku terapije.
ANBL0032 was a randomised, controlled study that evaluated the effects of dinutuximab administered in combination with GM-CSF, IL-2, and isotretinoin compared with isotretinoin alone in high-risk neuroblastoma subjects.
ANBL0032 je bila randomizirana, kontrolirana študija za ocenjevanje učinkov dinutuksimaba, apliciranega v kombinaciji z GM-CSF, IL-2 in izotretinoinom, v primerjavi z zdravljenjem samo z izotretinoinom pri bolnikih z nevroblastomom z visokim tveganjem.
No cases of dinutuximab overdose have been reported.
Ni poročil o primerih prevelikega odmerjanja dinutuksimaba.
Specifically, in the presence of human effector cells including peripheral blood mononuclear cells (PBMC) and granulocytes from normal human donors, dinutuximab was found to mediate the lysis of several neuroblastoma cell lines in a dose-dependent manner.
vključno s perifernimi mononuklearnimi krvnimi celicami (PBMC- peripheral blood mononuclear cells) in granulociti iz zdravih človeških darovalcev, povzroča lizo številnih celičnih linij nevroblastoma, sorazmerno z odmerkom.
Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa.
Dinutuksimab je himerno monoklonsko protitelo, sestavljeno iz mišje lahke in težke verige v variabilni domeni in humane težke verige IgG1 ter lahke verige kapa v konstantni domeni.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
Capillary leak syndrome was a very common adverse reaction (45 % of patients) that occurred more frequently when Unituxin was co-administered with IL-2; it was severe (> Grade 3) in 14% of patients.
Sindrom kapilarnih razpok je zelo pogost neželen učinek (45 % bolnikov), ki se je pojavil pogosteje, ko se je zdravilo Unituxin apliciralo skupaj z IL-2.
Dinutuximab has been shown to bind to neuroblastoma cell lines known to express GD2 in vitro.
Dokazano je bilo, da se dinutuksimab veže na celične linije nevroblastoma, za katere je znano, da izražajo GD2 in vitro.
Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway oedema, dyspnoea, bronchospasm, stridor, urticaria, and hypotension.
Resne infuzijske reakcije, za katere je potrebno nujno ukrepanje, vključno s podporno terapijo za krvni tlak, terapijo z bronhodilatatorjem, kortikosteroidi, zmanjšanjem hitrosti infundiranja ali dokončno prekinitvijo zdravljenja z zdravilom Unituxin, so obsegale edem obraza in zgornjih dihal, dispnejo, bronhospazem, stridor, urtikarijo in hipotenzijo.
Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Preiskave in preverjanja V obdobju uporabe tega zdravila bo vaš zdravnik izvajal preiskave krvi in morebitne preglede oči.
Augmentation of ADCC in the presence of GM-CSF and IL-2 provided the rationale for combining these cytokines with dinutuximab in clinical studies.
Zaradi povečanja ADCC v prisotnosti GM-CSF in IL-2 se v kliničnih študijah te citokine kombinira z dinutuksimabom.
The required volume of dinutuximab should be withdrawn and injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Odvzemite potrebni volumen dinutuksimaba in ga injicirajte v 100-mililitrsko vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopine za injekcije.
What Unituxin is and what it is used for
Kaj je zdravilo Unituxin in za kaj ga uporabljamo