FrancophonIA/ELRC3.0 huggingface dataset:
English: The ziconotide dose should be reduced or discontinued if signs or symptoms of cognitive impairment or neuropsychiatric adverse reactions develop, but other contributing causes should also be considered.
Slovenian: Če se razvijejo znaki ali simptomi kognitivnih okvar ali nevropsihiatrični neželeni učinki, je treba odmerek zikonotida zmanjšati ali z uporabo zdravila prenehati, vendar je treba upoštevati tudi druge vzroke, ki k motnji lahko prispevajo.
English: When low doses of ziconotide are required, for example when initiating titration, ziconotide must be diluted before use with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Kadar so potrebni majhni odmerki zikonotida, na primer pri uvajanju titriranja, moramo zikonotid pred uporabo razredčiti z 0,9-odstotno raztopino (9 mg/ml) natrijevega klorida za injekcije brez konzervansa.
English: Ziconotide was not teratogenic in rats and rabbits at exposures < 100 times human plasma levels.
Slovenian: Zikonotid pri podganah in zajcih ob odmerkih,< od 100-kratne plazemske ravni pri ljudeh, ni bil teratogen.
English: Prialt is supplied as a clear, colourless solution in single use vials.
Slovenian: Zdravilo Prialt je na razpolago v obliki prozorne, brezbarvne raztopine v vialah za enkratno uporabo.
English: • Anaphylactic reaction (it is not known how many people this affects) - is a severe allergic reaction, the signs of which are sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Slovenian: • Anafilaktična reakcija (ni znano, pri koliko ljudeh se pojavi) - je težka alergijska reakcija, katere znaki so nenadno sopenje, težave pri dihanju, bolečina v prsih, otekanje vek.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/302/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/302/004
English: Sodium chloride Water for injections Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
Slovenian: 6.1 Seznam pomožnih snovi metionin natrijev klorid voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: In-use shelf-life (diluted product) Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Slovenian: Rok uporabnosti med uporabo (razredčeno zdravilo) Kemična in fizikalna stabilnost med uporabo znaša 60 dni pri 37 °C.
English: • Convulsions (may affect up to 1 in 100 people) - convulsions (fits) are when a person's body shakes rapidly and uncontrollably.
Slovenian: • Epileptični napadi (lahko se pojavijo pri največ 1 bolniku od 100 bolnikov) - pri epileptičnih napadih se bolnikovo telo hitro in nenadzorovano trese.
English: In some patients who received intrathecal doses greater than the maximum recommended dose, exaggerated pharmacological effects, e.g., ataxia, nystagmus, dizziness, stupor, depressed level of consciousness, muscle spasms, confusional state, sedation, hypotension, aphasia, speech disorder, nausea and vomiting were observed.
Slovenian: Pri nekaterih bolnikih, ki so intratekalno prejeli višje odmerke od največjega priporočenega odmerka, so bili opaženi povečani farmakološki učinki, na primer, ataksija, nistagmus, omotičnost, stupor, zmanjšana stopnja zavesti, mišični krči, zmedenost, sedacija, hipotenzija, afazija, motnje govora, slabost in bruhanje.
English: EU/1/04/302/002 - 2 ml solution for infusion.
Slovenian: EU/1/04/302/004 - 20 ml raztopina za infundiranje
English: If you feel that you are still in too much pain while receiving Prialt, or that the side effects are too great, talk to your doctor.
Slovenian: Če občutite, da so vaše bolečine kljub prejemanju zdravila Prialt premočne ali neželeni učinki preveliki, se pogovorite z zdravnikom.
English: Studies have not been conducted in patients with impaired renal function.
Slovenian: Na bolnikih z okvarjeno ledvično funkcijo študije niso bile opravljene.
English: - The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Slovenian: Druge sestavine zdravila so metionin, natrijev klorid, voda za injekcije, klorovodikova kislina in natrijev hidroksid.
English: When adding IT ziconotide to stable doses of IT morphine, as with the initiation of IT ziconotide monotherapy, the appearance of psychotic adverse reactions (e.g., hallucinations, paranoid reactions) or discontinuation due to increased adverse reactions may occur.
Slovenian: Kadar se IT zikonotid dodaja ustaljenim odmerkom IT morfina, kot ob začetku monoterapije z IT zikonotidom, lahko pride do pojava neželenih psihotičnih učinkov (npr. halucinacij, paranoidnih reakcij) ali do prekinitve zdravljenja zaradi povečanja neželenih učinkov (glejte poglavje 4.5).
English: - If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Renal and urinary disorders urinary retention, urinary hesitation, dysuria, urinary incontinence acute renal failure
Slovenian: Bolezni sečil retencija urina, tiščanje na vodo, dizurija, urinska inkontinenca akutna odpoved ledvic
English: LIST OF EXCIPIENTS methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Slovenian: SEZNAM POMOŽNIH SNOVI metionin, natrijev klorid, voda za injekcije, klorovodikova kislina in natrijev hidroksid
English: Marketing Authorisation Holder: RIEMSER Pharma GmbH An der Wiek 7
Slovenian: Imetnik dovoljenja za promet: RIEMSER Pharma GmbH An der Wiek 7
English: Prialt has been shown to be chemically and physically compatible with the implantable Synchromed pump and the external CADD-Micro pump at the concentration levels indicated above.
Slovenian: Pri zgoraj navedenih koncentracijah je bilo zdravilo Prialt ob uporabi s Synchromed implantacijsko infuzijsko črpalko ali zunanjo CADD-Micro črpalko kemično in fizikalno stabilno.
English: Vascular disorders orthostatic hypotensi on, hypotension
Slovenian: Žilne bolezni ortostatska hipotenzija, hipotenzija
English: 500 micrograms/20ml
Slovenian: 500 mikrogramov/20 ml
English: 1 vial of 5 ml 5ml
Slovenian: 1 viala po 5 ml 5 ml
English: Prialt should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Zdravilo Prialt je treba pred uporabo vizualno kontrolirati glede prisotnosti delcev in spremembe barve raztopine.
English: The mean plasma elimination half-life (t½) is 1.3 hr. Ziconotide is a relatively small molecular weight peptide (MW = 2,639) and is filtered by the kidney glomerulus, but only minimal amounts of ziconotide (< 1%) are recovered in human urine following intravenous infusion.
Slovenian: Srednji eliminacijski razpolovni čas v plazmi znaša 1,3 h. Zikonotid je peptid z relativno majhno molekulsko maso (MW = 2.639) in se v ledvičnih glomerulih filtrira, vendar je po intravenski infuziji iz urina mogoče izolirati le minimalne količine zikonotida (< 1%), ker je skoraj vsa filtrirana aktivna snov podvržena hitri endocitozi in takojšnjemu prenosu nazaj v sistemski krvni obtok.
English: CSF and Plasma Pharmacokinetics of Ziconotide [mean ± SD (median)]
Slovenian: Farmakokinetika zikonotida v cerebrospinalni tekočini in v plazmi (povprečje ± SD (mediana))
English: Postural hypotension was observed in almost all subjects who received high intravenous doses of ziconotide.
Slovenian: Pri skoraj vseh osebah, ki so prejele visok intravenski odmerek zikonotida, so opazili posturalno hipotenzijo.
English: Prialt may also cause or worsen depression in people that are already susceptible.
Slovenian: Zdravilo Prialt lahko pri občutljivih bolnikih povzroči ali poglobi depresijo s tveganjem za samomor.
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Slovenian: Kadar je zikonotid apliciran bolnikom, ki prejemajo sistemsko kemoterapijo, je potrebna previdnost (glejte poglavje 4.5.
English: Psychiatric disorders confusional state anxiety, auditory hallucination, insomnia, agitation, disorientation, hallucination, visual hallucination, depression, paranoia, irritability, depression aggravated, nervousness, affect lability, mental status changes, anxiety aggravated, confusion aggravated delirium, psychotic disorder, suicidal ideation, suicide attempt, thought blocking, abnormal dreams, aggressiveness
Slovenian: Psihiatrične motnje zmedenost anksioznost, slušne halucinacije, nespečnost, vznemirjenost, dezorientacija, halucinacije, vidne halucinacije, depresija, paranoja, razdražljivost, poslabšanje depresije, nervoza, čustvena labilnost, spremembe mentalnega statusa, poslabšanje anksioznosti, poslabšanje zmedenosti delirij, psihotične motnje, razmišljanje o samomoru, poizkus samomora, blokada mišljenja, nenormalne sanje, agresivnost
English: Skin and subcutaneous pruritus, sweating rash
Slovenian: Bolezni kože in podkožja srbenje, zvečano znojenje izpuščaj
English: In rat fertility studies, there were no effects in males while reductions in corpora lutea; implantation sites and number of live embryos were observed in females.
Slovenian: V študijah plodnosti na podganah ni bilo nobenega učinka na samčke, pri samičkah pa so opazili zmanjšanje pri rumenih telescih, mestih implantacije in številu živih zarodkov.
English: Warnings and precautions Talk to your doctor before you are given Prialt - The effects of long-term treatment of Prialt are uncertain at this time and the possibility of toxic effects on the spinal cord have not yet been ruled out.
Slovenian: Učinki dolgoročne uporabe zdravila Prialt so zaenkrat nejasni in možnosti toksičnih učinkov na podaljšano hrbtenjačo še niso izključili.
English: 1 vial of 2 ml 2ml
Slovenian: 1 viala po 2 ml 2 ml
English: Ziconotide appears to distribute mainly within the CSF until transferred to the systemic circulation.
Slovenian: Videti je, da se zikonotid do prehoda v sistemski krvni obtok porazdeli predvsem po cerebrospinalni tekočini.
English: Studies have not been conducted in patients with impaired hepatic function.
Slovenian: Na bolnikih z okvarjeno jetrno funkcijo študije niso bile opravljene.
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.4).
Slovenian: Kadar je zikonotid apliciran bolnikom, ki prejemajo sistemsko kemoterapijo, je potrebna previdnost (glejte poglavje 4.4.
English: There were three placebo-controlled clinical trials of IT ziconotide.
Slovenian: Z intratekalno apliciranim zikonotidom so bile izvedene tri s placebom kontrolirane študije.
English: Discontinuation of ziconotide should be considered in the event of progressive or significant elevation of creatine phosphokinase in association with clinical features of myopathy or rhabdomyolysis (see section 4.4).
Slovenian: V primeru progresivnega zvišanja ali klinično pomembnega zvišanja v povezavi s klinično sliko miopatije ali rabdomiolize je treba razmisliti o ukinitvi zikonotida (glejte poglavje 4.4).
English: Episodes of acute psychiatric disturbances, such as hallucinations, paranoid reactions, hostility, aggressiveness, delirium, psychosis and manic reactions have been reported in patients treated with ziconotide.
Slovenian: Pri bolnikih, zdravljenih z zikonotidom, so opazili tudi epizode akutnih psihiatričnih motenj, kot so halucinacije, paranoidne reakcije, sovražnost, agresivnost, delirij, psihoze in manične reakcije.
English: 100 micrograms /1ml
Slovenian: 100 mikrogramov/1 ml
English: No adverse effects on female reproduction and post-natal development in rats were seen at systemic exposures up to 2,300 times human exposures at the maximum recommended intrathecal dose.
Slovenian: Pri podganah ob sistemski izpostavljenosti, ki je bila do 2.300-krat večja od največje priporočene intratekalne izpostavljenosti pri ljudeh, niso opazili neželenih učinkov na reprodukcijo samičk in na post-natalni razvoj.
English: Decreased appetite, anxiety or worsened anxiety, hallucinations, inability to fall or stay asleep, agitation, disorientation, depression or worsened depression, nervousness, mood swings, mental status changes (thinking abnormal, confusion), paranoia, irritability, worsened confusion, difficulty with learning, memory or thinking, reflexes absent or impaired, problems expressing or understanding words, slurred speech, difficulty with speech or loss of ability to speak, sluggishness, balance or coordination impaired, burning sensation, increased abnormal sensation, reduced level of consciousness (unresponsive or almost unconscious), sedation, difficulty in concentrating, problems with the sense of smell, odd or no sense of taste, shaking, pins and needles, double vision, visual disturbance, intolerance to light, tinnitus (ringing in the ears), dizziness or spinning sensation, lightheadedness or dizziness when standing, low blood pressure, shortness of breath, dry mouth, abdominal pain, worsened nausea, diarrhoea, constipation, sweating, itching, muscle weakness, muscle spasms, muscle cramp, muscle or joint pain, difficult or painful urination, difficulty starting or controlling urination, feeling jittery, falling, pain or pain exacerbated, fatigue, feeling cold, swelling of the face, legs or feet, chest pain, blood chemistry changes, mental impairment and weight decreased.
Slovenian: Pogosti (pojavljajo se lahko pri 1 do 10 od 100 bolnikov) zmanjšanje teka, anksioznost ali okrepljena anksioznost, halucinacije, nezmožnost zaspati ali spati, vznemirjenje, dezorientacija, depresija ali poslabšana depresija, nervoznost, nihanje razpoloženja, spremembe mentalnega statusa (nenormalno razmišljanje, zmedenost), preganjavica, razdražljivost, poslabšanje zmedenosti, težave pri učenju, pomnjenju ali razmišljanju, odsotnost refleksov ali okrnjeni refleksi, težave z izražanjem in razumevanjem besed, nerazločen govor, težave pri govorjenju ali izguba sposobnosti govorjenja, medlost (lenoba), prizadet občutek za ravnotežje ali koordinacijo, pekoči občutki, zvečani nenormalni občutki, zmanjšana stopnja zavesti (neodzivnost ali rob nezavesti), sedacija, težave pri koncentraciji, težave z vonjanjem, čuden okus ali izguba sposobnosti okušanja, tresenje, zbadanje, dvojen vid, motnje vida, neprenašanje svetlobe, tinitus (zvonjenje v ušesih), omotica ali občutek vrtoglavice, omotičnost ali vrtoglavost v stoječem položaju, nizek krvni tlak, kratka sapa, suha usta, bolečine v trebuhu, poslabšanje slabosti, driska, zaprtje, potenje, srbenje, mišična šibkost, mišični krči, bolečine v mišicah ali sklepih, oteženo ali boleče uriniranje, težave ob začetku uriniranja ali nadzorovanju uriniranja, občutek živčnosti, padanje, bolečine ali okrepitev bolečine, utrujenost, občutek mraza, potenje obraza, nog ali stopal, bolečine v prsih, spremembe krvnih vrednosti, poslabšanje mentalnih sposobnosti in znižanje telesne mase
English: 1 vial of 1 ml 1ml
Slovenian: 1 viala po 1 ml 1 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Prialt 100 μg/ml infusion
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Prialt 100 µg/ml infuzija zikonotid intratekalna uporaba
English: The event may be self limited, but ziconotide should be discontinued until the event resolves.
Slovenian: Dogodek lahko mine sam od sebe, toda dokler se bolnik ne povrne v normalno stanje, je potrebno apliciranje zdravila prekiniti.
English: The introduction of air into the pump reservoir or cartridge should be minimized, as oxygen can degrade ziconotide.
Slovenian: Ker zikonotid pod vplivom kisika lahko razpade, je potrebno dostop kisika v rezervoar črpalke ali vložka zmanjšati na minimum.
English: Vomiting and anorexia, and peripheral oedema were also observed when IT ziconotide was added to IT morphine.
Slovenian: Ob dodajanju IT zikonotida IT morfinu so zabeležili tudi pojave bruhanja, anoreksije in perifernega edema.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 25 μg ziconotide (as acetate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml raztopine vsebuje 25 µg zikonotida (v obliki acetata).
English: Strict aseptic procedures must be used during the preparation and handling of the solution for infusion and refilling of the pump.
Slovenian: Priprava in ravnanje z raztopino za infundiranje ter polnjenje črpalke morajo potekati pod striktnimi aseptičnimi pogoji.
English: 200 micrograms/2ml
Slovenian: 200 mikrogramov/2 ml
English: General disorders and administration site conditions gait abnormal, asthenia fatigue, pyrexia, lethargy, oedema peripheral, rigors, fall, chest pain, feeling cold, pain, feeling jittery, pain exacerbated difficulty in walking
Slovenian: Splošne težave in spremembe na mestu aplikacije nenormalna drža, astenija utrujenost, pireksija, letargija, periferni edemi, rigor, padanje, bolečina v prsih, občutek mraza, bolečine, občutek živčnosti, izbruh bolečine težave pri hoji
English: In binding to these neuronal NCCs ziconotide inhibits the voltage sensitive calcium current into primary nociceptive afferents terminating in the superficial layers of the dorsal horn of the spinal cord.
Slovenian: Ob vezavi na te nevrone zikonotid zavira od napetosti odvisen pretok kalcija v primarne nociceptivne aferentne živčne končiče, ki se končujejo v površinskih slojih dorzalnih rogov hrbtenjače, kar zavre sproščanje nevrotransmiterjev iz njih (vključno s substanco P) in s tem prenos bolečinskih signalov po hrbtenjači.
English: Gastrointestinal disorders nausea, vomiting diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain dyspepsia
Slovenian: Bolezni prebavil slabost, bruhanje driska, suha usta, zaprtje, poslabšanje slabosti, bolečina v zgornjem delu trebuha dispepsija
English: Very low circulating plasma concentrations of ziconotide may be observed following IT administration due to both the low IT infusion rate and relatively rapid plasma clearance.
Slovenian: Zaradi majhne hitrosti intratekalne infuzije in relativno hitrega plazemskega očistka zikonotida so po intratekalni aplikaciji v plazmi lahko ugotovljene le zelo nizke plazemske koncentracije.
English: If needed, the dose may be decreased or injection stopped if the side effects are too great.
Slovenian: Če bi bili neželeni učinki preveliki, se po potrebi odmerek lahko zmanjša ali injiciranje ustavi.
English: Marketing Authorisation Holder RIEMSER Pharma GmbH An der Wiek 7
Slovenian: Imetnik dovoljenja za promet RIEMSER Pharma GmbH An der Wiek 7
English: You may feel drowsy if you are given Prialt with certain other medicines used to treat pain.
Slovenian: Če prejemate zdravilo Prialt hkrati z nekaterimi drugimi zdravili proti bolečinam, lahko občutite omotico.
English: 500 micrograms/5ml
Slovenian: 500 mikrogramov/5 ml
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 μg ziconotide (as acetate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml raztopine vsebuje 100 µg zikonotida (v obliki acetata).
English: Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Slovenian: Podatkov o interakcijah med IT zikonotidom in IT kemoterapevtiki ni. Zikonotid je v kombinaciji z IT kemoterapevtiki kontraindiciran (glejte poglavje 4.3).
English: EU/1/04/302/003 - 5 ml solution for infusion.
Slovenian: EU/1/04/302/001 - 1 ml raztopina za infundiranje EU/1/04/302/002 - 2 ml raztopina za infundiranje EU/1/04/302/003 - 5 ml raztopina za infundiranje
English: If dilution is required, Prialt must be diluted aseptically with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection before use.
Slovenian: Če je potrebno redčenje, je treba zdravilo Prialt pred uporabo razredčiti z nekonzervirano 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za injiciranje pod aseptičnimi pogoji.
English: CE marked pumps equivalent to the Synchromed and CADD-Micro pump should be used to deliver ziconotide.
Slovenian: Za aplikacijo zdravila Prialt morajo biti uporabljene s CE označene črpalke, ekvivalentne Synchromed in CADD-Micro črpalki.
English: Pumps previously used to deliver other medicinal products must be washed out three times with sodium chloride 9 mg/ml (0.9%) solution for injection (preservative-free) before being filled with Prialt.
Slovenian: Črpalke, ki so bile prej uporabljene za aplikacijo drugih zdravil, morajo biti pred polnjenjem z zdravilom Prialt trikrat izprane z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za injiciranje (nekonzervirano).
English: Nervous system disorders dizziness, nystagmus, memory impairment, headache, somnolence dysarthria, amnesia, dysgeusia, tremor, balance impaired, ataxia, aphasia, burning sensation, sedation, paraesthesia, hypoaesthesia, disturbance in attenti on, speech disorder, areflexia, coordination abnorm al, dizziness postural, cognitive disorder, hyperaesthesia, hyporeflexia, ageusia, depressed level of consciousness, dysaesthesia, parosmia, mental impairment incoherence, loss of consciousness, coma, stupor, convulsions, cerebrovascular accident, encephalopathy
Slovenian: Bolezni živčevja omotica, nistagmus, motnje spomina, glavobol, zaspanost dizartrija, izguba spomina, motnje okušanja, tremor, motnje ravnotežja, ataksija, afazija, pekoči občutki, sedacija, parestezije, hipoestezija, motnje pozornosti, motnje govora, arefleksija, nenormalna koordinacija, posturalna omotica, kognitivne motnje, hiperestezija, hiporefleksija, izguba sposobnosti okušanja, stanje zmanjšane zavesti, disestezija, motnje voha, poslabšanje mentalnih sposobnosti inkoherenca, izguba zavesti, koma, stupor, krči, cerebrovaskularni dogodek, encefalopatija
English: Dose at end of titration (μg/hr) Mean Median Range aResponders were defined as those who experienced a ≥ 30% drop in VASPI score compared to baseline.
Slovenian: povprečni mediani razpon a Kot odzivni bolniki so bili definirani tisti bolniki, ki so izkazali ≥ 30-odstotno znižanje VASPI
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaktična reakcijaa
English: NAME OF THE MEDICINAL PRODUCT Prialt 25 micrograms/ml solution for infusion
Slovenian: IME ZDRAVILA Prialt 25 mikrogramov/ml raztopina za infundiranje
English: Musculoskeletal and connective tissue disorders pain in limb, myalgia, muscle spasms, muscle cramp, muscle weakness, arthralgia, peripheral swelling rhabdomyolysis, myositis, back pain, muscle twitching, neck pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v udih, bolečine v mišicah, mišični spazmi, mišični krči, mišična šibkost, bolečine v sklepih, periferno otekanje rabdomioliza, miozitis, bolečine v hrbtu, trzanje mišic, bolečine v vratu
English: You must tell your doctor immediately if you experience any of the above symptoms.
Slovenian: Če občutite kateregakoli od zgoraj naštetih simptomov, morate nemudoma obvestiti zdravnika.
English: CNS adverse reactions
Slovenian: Neželeni učinki na CŽS
English: Caution should be exercised when ziconotide is administered to patients with impaired hepatic function.
Slovenian: Zaradi tega je ob uporabi zikonotida pri bolnikih z okvarjeno jetrno funkcijo potrebna posebna previdnost.
English: NAME OF THE MEDICINAL PRODUCT Prialt 100 micrograms/ml solution for infusion
Slovenian: IME ZDRAVILA Prialt 100 mikrogramov/ml raztopina za infundiranje
English: Each 2 ml vial contains 200 μg ziconotide (as acetate).
Slovenian: Ena 2 ml viala vsebuje 200 µg zikonotida (v obliki acetata).
English: Caution should be exercised when ziconotide is administered to patients with impaired renal function.
Slovenian: Zaradi tega je ob uporabi zikonotida pri bolnikih z okvarjeno ledvično funkcijo potrebna posebna previdnost.