FrancophonIA/ELRC3.0 huggingface dataset:
English: Prialt is supplied in packs containing a single vial of either 1 ml, 2 ml or 5 ml.
Slovenian: Zdravilo Prialt je na voljo v pakiranjih, ki vsebujejo posamezno 1-ml, 2-ml ali 5-ml vialo.
English: One vial per carton.
Slovenian: Ena viala na vsebnik.
English: Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.
Slovenian: V CADD-Micro črpalki je bila stabilnost dokazana za 21 dni uporabe pri sobni temperaturi.
English: Prialt is supplied in packs containing a single vial of 20 ml.
Slovenian: Zdravilo Prialt je na voljo v pakiranjih, ki vsebujejo posamezno 20 ml vialo.
English: Specific clinical medicinal product interaction studies have not been conducted with ziconotide.
Slovenian: Specifične klinične študije o medsebojnem delovanju z drugimi zdravili za zikonotid niso bile opravljene.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za infundiranje.
English: Type I glass vials with butyl rubber stoppers coated with fluorinated polymer.
Slovenian: Steklena viala iz nevtralnega stekla tipa 1 z zamaškom iz butil-kavčuka, prekritega s fluoriranim polimerom.
English: The maximum intended intrathecal dose of ziconotide in clinical trials was 912 μg/day following upward titration over 7 days.
Slovenian: Največji predvideni intratekalni odmerek zikonotida v kliničnih študijah je znašal 912 µg/dan in je bil dosežen s postopnim večanjem odmerka tekom 7 dni.
English: What Prialt contains - The active substance is ziconotide.
Slovenian: Kaj vsebuje zdravilo Prialt - Zdravilna učinkovina je zikonotid.
English: Ziconotide is a peptide consisting of 25 naturally-occurring amino acids of the L-configuration, and does not appear to be appreciably metabolised in the CSF.
Slovenian: Zikonotid je peptid, sestavljen iz 25 v naravi pojavljajočih se aminokislin z levosučno konfiguracijo, in ni videti, da bi se v cerebrospinalni tekočini presnavljal v upoštevanja vredni meri.
English: However, maximal effects may be delayed for approximately 24 hours in some patients.
Slovenian: Vendar pa so pri nekaterih bolnikih opazili za približno 24 ur zakasnjen maksimalni odziv na zdravilo.
English: - If you observe any signs of infection around the tube, such as skin redness, swelling, pain or discharge, you must tell your doctor immediately and seek treatment for the infection.
Slovenian: - Če okrog cevke opazite znake infekcije, kot je na primer rdečina, otekanje, bolečina ali izloček, nemudoma obvestite zdravnika in poskrbite, da se začne infekcija zdraviti.
English: Upon reaching the systemic circulation, ziconotide appears to be more extensively distributed, based on a plasma distribution volume of approximately 30 l and is only about 53% bound (non-specifically) to human plasma proteins.
Slovenian: Po prehodu v sistemski krvni obtok se zikonotid bolj intenzivno porazdeli, plazemski volumen porazdelitve znaša približno 30 l, in se le okrog 53 % (nespecifično) veže na plazemske beljakovine.
English: In one clinical study a male cancer patient received an accidental IT ziconotide overdose of 744 μg over a 24-hour period (31 μg/hour) and resumed treatment at the intended dose after experiencing a reduction in Visual Analog Scale of Pain Intensity (VASPI) from 82 to 2.5 mm.
Slovenian: V eni od kliničnih študij je bolnik moškega spola, obolel za rakom, nenamerno v 24 urah intratekalno prejel 744 µg zikonotida (31 µg/uro) in bil naprej zdravljen s predvidenim odmerkom, ko so na vizualni analogni bolečinski skali (Visual Analog Scale of Pain Intensity, VASPI) ugotovili zmanjšanje vrednosti z 82 na 2,5 mm.
English: Chronic animal studies have not been performed to assess the carcinogenic potential of ziconotide.
Slovenian: Dolgoročne študije za ocenitev karcinogenega potenciala zikonotida na živalih niso bile izvedene.
English: The maximum dose is 21.6 micrograms/day.
Slovenian: Največji dnevni odmerek znaša 21,6 mikrogramov.
English: General medical supportive measures should be administered to patients who receive an overdose until the exaggerated pharmacological effects of the medicinal product have resolved.
Slovenian: Bolniki, ki so prejeli prevelike odmerke, potrebujejo splošno podporno zdravljenje dokler znaki premočnega farmakološkega delovanja ne izzvenijo.
English: Though statistically significant relationships and reasonable correlation between cerebrospinal fluid (CSF) exposure (AUC, Cmax) and clinical response measures have been observed following 1 hour IT administration, no well-defined dose-concentration-response relationships have yet been identified.
Slovenian: Čeprav so bila po enourni intratekalni aplikaciji zdravila opažena statistično signifikantna razmerja in razumna korelacija med koncentracijo zdravila v cerebrospinalni tekočini (AUC, Cmax) in meritvami kliničnega odgovora, dobro definirana razmerja med odmerkom, koncentracijo in odgovorom še niso bila ugotovljena.
English: If this happens, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Slovenian: Če se to zgodi, morate nemudoma obvestiti zdravnika, ker se bo morda odločil za prenehanje zdravljenja z zdravilom Prialt.
English: There is no evidence of the development of pharmacological tolerance to ziconotide in patients.
Slovenian: O razvoju farmakološke tolerance bolnikov na zikonotid ni dokumentiranih podatkov.
English: Ziconotide (n = 71)
Slovenian: Parameter zikonotid (n = 71)
English: No specific studies with ziconotide in humans have been conducted to evaluate effects on fertility.
Slovenian: Pri ljudeh posebnih študij z zikonotidom za oceno učinkov na plodnost niso opravili.
English: No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.
Slovenian: Glede sočasne uporabe delnih opioidnih agonistov (npr. buprenorfina) in zikonotida ni razpoložljivih podatkov.
English: The maximum recommended intrathecal dose is 21.6 μg/day.
Slovenian: Največji priporočeni intratekalni odmerek znaša 21,6 µg/dan.
English: Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.
Slovenian: Kognitivni in nevropsihiatrični neželeni učinki, zlasti zmedenost, so pri bolnikih, zdravljenih z zikonotidom, pogosti.
English: Patients should be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day.
Slovenian: Titracija naj poteka postopoma v korakih, ≤ 2,4 µg/dan do maksimalnega odmerka 21,6 µg/dan.
English: It is an N-type calcium channel blocker (NCCB).
Slovenian: Gre za N-tip zaviralca kalcijevih kanalčkov.
English: However monitoring of creatine kinase is recommended.
Slovenian: Vseeno je kreatin kinazo priporočljivo spremljati.
English: Investigations blood creatine phosphokina se increased, weight decreased electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased a. From spontaneous reporting
Slovenian: Preiskave zvišana kreatinfosfokinaza v krvi, zmanjšanje telesne mase nenormalen elektrokardiogram, zvišana aspartataminotransferaza, zvišana kreatinfosfokinaza MM v krvi, zvišana telesna temperatura a. iz spontanih poročil
English: - You may have an increased level of an enzyme called creatine kinase in your blood and although this does not usually cause any symptoms or problems, your doctor is likely to monitor its level.
Slovenian: - Lahko boste imeli zvišano aktivnost encima, ki mu rečemo kreatin kinaza, v krvi in zdravnik bo morda želel preverjati njegovo aktivnost, čeprav zvišanje ponavadi ne povzroča nobenih simptomov ali težav.
English: Metabolism and nutrition disorders appetite decreased, anorexia
Slovenian: Presnovne in prehranske motnje zmanjšanje apetita, anoreksija
English: - If you are receiving Prialt via a pump worn outside your body and any part of the infusion tubing becomes disconnected, you must contact your doctor or nurse immediately.
Slovenian: - Če prejemate zdravilo Prialt preko črpalke, ki jo nosite izven svojega telesa, in se infuzijski sistem na katerem koli mestu prekine, se nemudoma povežite z zdravnikom ali medicinsko sestro.
English: Mean Median Range aResponders were defined as those patients who 1) experienced a ≥ 30% drop in VASPI score compared to baseline; 2) had stable or decreased concomitant opioid analgesics; and 3) had opiate type unchanged from preinfusion if receiving opiates.
Slovenian: povprečni mediani razpon aKot odzivni bolniki so bili definirani tisti bolniki, ki so 1) izkazali ≥ 30-odstotno znižanje VASPI vrednosti glede na izhodiščno vrednost, 2) imeli stabilno ali zmanjšano potrebo po opiatnih analgetikih in 3) v primeru, da so prejemali opiate, niso spremenili tipa opiatov.
English: In the event of progressive elevation, or clinically significant elevation in association with clinical features of myopathy or rhabdomyolysis, discontinuation of ziconotide should be considered.
Slovenian: V primeru progresivnega povečanja ali klinično pomembnega povečanja v povezavi s klinično sliko miopatije ali rabdomiolize je potrebno razmisliti o ukinitvi zikonotida.
English: The addition of IT morphine to stable doses of IT ziconotide is better tolerated (pruritis has been reported) (see section 5.1).
Slovenian: Boljše prenašanje se doseže z dodajanjem IT morfina ustaljenim odmerkom IT zikonotida (poročajo o pojavu pruritusa) (glejte poglavje 5.1).
English: - If you are receiving Prialt via a pump worn outside your body, it is important you check once daily for any signs of infection at the point where the tube enters your body.
Slovenian: - Če prejemate zdravilo Prialt preko črpalke, ki jo nosite izven svojega telesa, je pomembno, da enkrat na dan preverite, če na mestu vstopa cevke v vaše telo ni prišlo do znakov infekcije.
English: Very common (may affect more than 1 user in 10) Confusion, dizziness, blurred vision, headache, rapid back-and-forth movement of the eyes, loss or impairment of memory (forgetfulness), vomiting, nausea, general weakness and drowsiness.
Slovenian: Zelo pogosti (pojavljajo se lahko pri več kot 1 od 10 bolnikov) zmedenost, omotica, zamegljen vid, glavobol, hito premikanje oči, izguba ali prizadetost spomina (pozabljivost), bruhanje, slabost, splošna oslabelost in dremavost
English: An increased incidence of somnolence has been observed when ziconotide is administered concomitantly with systemic baclofen, clonidine, bupivacaine or propofol thus for the time being their simultaneous use is discouraged.
Slovenian: Ob sočasni aplikaciji zikonotida in sistemsko apliciranega baklofena, klonidina, bupivakaina ali propofola je bila pri bolnikih pogosteje opažena zaspanost, zato zaenkrat njihova sočasna uporaba ni priporočljiva.
English: Patients have experienced depressed levels of consciousness while receiving ziconotide.
Slovenian: Bolniki so ob prejemanju zikonotida izkazovali zmanjšano stopnjo zavesti.
English: If you receive more Prialt than your doctor intended, you may feel unwell with signs such as confusion, problems with speech, word finding difficulties, excessive shaking, light-headedness, excessive sleepiness, feeling or being sick.
Slovenian: Če ste prejeli večji odmerek zdravila Prialt, kot bi smeli Če ste prejeli večji odmerek zdravila Prialt od tistega, ki ga je vaš zdravnik določil, se boste morda počutili slabo in opazili znake, kot je zmedenost, težave pri govoru, težave ob iskanju prave besede, pretirano tresenje, vrtoglavico, pretirano zaspanost, občutek slabosti ali bruhanje.
English: Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of Prialt at 25 μg/ml.
Slovenian: Pred začetkom terapije mora biti implantacijska črpalka trikrat izprana z 2 ml zdravila Prialt v koncentraciji 25 µg/ml.
English: - The other ingredients (excipients) are methionine, sodium chloride, water for injections,
Slovenian: - Druge sestavine zdravila (pomožne snovi) so metionin, natrijev klorid, voda za injekcije,
English: The most common adverse reactions reported in long-term clinical trials were dizziness (42%), nausea (30%), nystagmus (23%), confusional state (25%), gait abnormal (16%), memory impairment (13%), vision blurred (14%), headache (12%), asthenia (13%), vomiting (11%), and somnolence (10%).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali pri dolgoročnih kliničnih študijah, so bili omotičnost (42 %), slabost (30 %), nistagmus (23 %), zmedenost (25 %), nenormalna drža (16 %), motnje spomina (13 %), zamegljen vid (14 %), glavobol (12 %), astenija (13 %), bruhanje (11 %) in zaspanost (10 %).
English: Each vial contains 20 ml solution for infusion.
Slovenian: Ena viala vsebuje 20 ml raztopine za infundiranje.
English: Two short-term studies, 95-001 (malignant pain) and 96-002 (non malignant pain), involving 366 patients, demonstrated the efficacy of IT ziconotide in severe chronic pain using the percent change in Visual Analog Scale of Pain Intensity (VASPI) as the primary efficacy measure.
Slovenian: Dve kratkoročni študiji, 95-001 (maligna bolečina) in 96-002 (nemaligna bolečina) pri 366 bolnikih, sta demonstrirali učinkovitost intratekalno apliciranega zikonotida ob močni kronični bolečini in sta kot primarno merilo učinkovitosti uporabili odstotno spremembo na vizualno analogni skali intenzitete bolečine (VASPI, Visual Analog Scale of Pain Intensity).
English: Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured), reduced urine production, muscle weakness, muscle aching and muscle tenderness.
Slovenian: Simptomi rabdomiolize so nenormalna barva seča (rjavo obarvan), zmanjšano nastajanje seča, šibkost mišic, bolečine v mišicah in občutljivost mišic.
English: Progressive elevation of the creatine kinase is uncommon.
Slovenian: Progresivno višanje kreatin kinaze je občasno.
English: Ask your doctor for advice before you drive or operate machinery.
Slovenian: Pred upravljanem vozil ali strojev se posvetujte z zdravnikom.
English: IT and intravenous pharmacokinetics data are summarised below.
Slovenian: Podatki o farmakokinetiki ob intratekalnem in intravenskem načinu aplikacije so zbrani v spodnji tabeli.
English: Adding IT ziconotide to stable doses of IT morphine (see section 5.1), is possible but requires special attention, as a high rate of neuropsychiatric adverse reactions (confusion/thinking abnormal, paranoid reactions and hallucinations, and abnormal gait), some of them serious, was observed in Study 202 despite a low dose of ziconotide.
Slovenian: IT zikonotid je možno dodajati ustaljenim odmerkom IT morfina (glejte poglavje 5.1), vendar pa to zahteva posebno pozornost, saj so v študiji 202 kljub nizkemu odmerku zikonotida opazili visok odstotek neželenih nevropsihiatričnih reakcij, nekatere od teh so bile resne (zmedenost/nenormalno razmišljanje, paranoidne reakcije in halucinacije in nenormalna hoja).
English: Combination with IT chemotherapy (see section 4.5).
Slovenian: Kombinacija z intratekalno obliko kemoterapije (glejte poglavje 4.5).
English: Clinical efficacy and safety There were three placebo-controlled clinical trials of IT ziconotide.
Slovenian: Klinična učinkovitost in varnost Z intratekalno apliciranim zikonotidom so bile izvedene tri s placebom kontrolirane študije.
English: Hypersensitivity reactions, including anaphylaxis, have not been observed during clinical trials and the immunogenicity of ziconotide administered by the IT route appears to be low.
Slovenian: Tekom kliničnih študij z zikonotidom niso opazili preobčuljivostnih reakcij (vključno z anafilakso), imunogenost IT apliciranega zikonotida pa se zdi nizka.
English: In a study on male and female fertility in rats no effects in males while reductions in corpora lutea; implantation sites and number of live embryos were observed in females (see section 5.3).
Slovenian: V študiji plodnosti samcev in samic pri podganah niso opazili učinkov na samce, pri samicah pa so opazili zmanjšanje rumenih telesc, ugnezditvenih mest in števila živih zarodkov (glejte poglavje 5.3).
English: Withdrawal of concomitant CNS depressant medicinal products should also be considered as they may contribute to the reduced level of arousal.
Slovenian: Prav tako je potrebno razmisliti o ukinitvi sočasne uporabe zdravil z zaviralnim učinkom na CŽS, ker lahko pripomorejo k zmanjšani stopnji budnosti.
English: Mean VASPI score at baseline in mm (SD) Mean VASPI score at end of initial titration in mm (SD) % improvement in VASPI score at end of initial titration (SD)
Slovenian: p-vrednost srednja VASPI vrednost na začetku v mm (SD) srednja VASPI vrednost na koncu inicialne titracije v mm (SD) % izboljšanja VASPI vrednosti ob koncu inicialne titracije (SD)
English: Tell your doctor if you are taking, have recently taken or might take any other medicines (for example, baclofen used to treat muscle spasticity, clonidine used to treat high blood pressure, bupivacaine used for local anaesthesia, morphine used for pain, propofol used for general anaesthesia, or any medicine which is administered by intrathecal injection (injection into the space that surrounds the spinal cord and the brain)).
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo (na primer baklofen, ki se uporablja za zdravljenje spastičnosti mišic, klonidin, ki se uporablja za zdravljenje zvišanega krvnega tlaka, bupivakain, ki se uporablja za lokalno anestezijo, morfin, ki se uporablja za blaženje bolečine, propofol, ki se uporablja za splošno anestezijo, ali katero koli zdravilo, ki se uporablja z intratekalno injekcijo (injekcija v prostor, ki obkroža hrbtenjačo in možgane)).
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide.
Slovenian: Priporočljivo je, da imajo bolniki pred začetkom intratekalnega zdravljenja z zikonotidom in po njem nevropsihiatrični pregled.
English: Symptoms of meningitis are headache, stiff neck, dislike of bright lights, fever, vomiting, confusion and drowsiness.
Slovenian: Simptomi meningitisa so glavobol, trd vrat, preobčutljivost za močno svetlobo (fotofobija), vročina, bruhanje, zmedenost in zaspanost.
English: Following one-hour IT administration (1 - 10 μg), both cumulative exposure (AUC; range: 83.6608 ng/h/ml) and peak exposure (Cmax; range: 16.4 - 132 ng/ml) values were variable and dose-dependent, but appeared only approximately dose-proportional.
Slovenian: Po enourni intratekalni aplikaciji (1-10 µg) sta bili kumulativna izpostavljenost (AUC; razpon 83,6608 ng/h/ml) in največja izpostavljenost (Cmax ; razpon 16,4 - 132 ng/ml) spremenljivi in odvisni od velikosti odmerka, vendar le delno proporcionalni velikosti odmerka.
English: You should not be given Prialt - If you are allergic to ziconotide or any of the other ingredients of this medicine (listed in section
Slovenian: Zdravila Prialt ne smete prejeti če ste alergični na zikonotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če prejemate zdravila proti raku v prostor okrog hrbtenjače.
English: Mean VASPI score at end of initial titration in mm (SD) % improvement in VASPI score at end of initial titration (SD) Respondera n (%)
Slovenian: p-vrednost srednja VASPI vrednost na začetku v mm (SD) srednja VASPI vrednost na koncu inicialne titracije v mm (SD) % izboljšanja VASPI vrednosti ob koncu inicialne titracije (SD) Odzivni bolnikia n (%)
English: Mean ziconotide CL (0.38 ml/min) approximates adult human CSF turnover rate (0.3 - 0.4 ml/min).
Slovenian: Srednji očistek zikonotida (0,38 ml/min) odgovarja hitrosti obnavljanja cerebrospinalne tekočine (turnover) pri odraslem človeku, ki znaša 0,3 do 0,4 ml/min.
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide (see section 4.4).
Slovenian: Priporočljivo je, da imajo bolniki pred začetkom intratekalnega zdravljenja z zikonotidom in po njem nevropsihiatrični pregled (glejte poglavje 4.4).
English: Low plasma exposure occurs during IT infusion due to the low recommended IT infusion rates and relatively rapid plasma clearance (see section 5.2).
Slovenian: Zaradi nizkih priporočenih hitrosti intratekalne infuzije in relativno hitrega plazemskega očistka (glejte poglavje 5.2.)
English: The CSF pharmacokinetics of ziconotide have been studied following one-hour IT infusions of 1 - 10 μg of ziconotide in patients with chronic pain.
Slovenian: Farmakokinetika zikonotida v cerebrospinalni tekočini je bila proučevana po enourni intratekalni infuziji 1 - 10 µg zikonotida, aplicirani bolnikom s kronično bolečino.
English: 1 vial of 20 ml
Slovenian: 1 viala po 20 ml
English: If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions.
Slovenian: Za obvladovanje neželenih učinkov se po potrebi odmerek lahko poljubno zmanjša (vključno s prekinitvijo infuzije).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2.)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Eye disorders vision blurred diplopia, visual disturbance, photophobia
Slovenian: Očesne bolezni zamegljen vid diplopija, motnje vida, fotofobija
English: In intravenous infusion studies, healthy male volunteers received ziconotide at doses of up to 70,000 μg/day or 3,200 times the maximum recommended daily intrathecal infusion dose.
Slovenian: Opravljene so bile študije, pri katerih je bilo zdravilo z intravensko infuzijo aplicirano zdravim prostovoljcem moškega spola, ki so prejeli zikonotid v odmerkih do 70.000 µg/dan, kar pomeni 3.200kratni največji priporočeni odmerek za intratekalno infuzijo.
English: NCCs regulate neurotransmitter release in specific neuronal populations responsible for the spinal processing of pain.
Slovenian: N-tip zaviralec kalcijevih kanalčkov uravnava sproščanje nevrotransmiterjev v specifičnih živčnih končičih, odgovornih za prevajanje bolečine po hrbtenjači.
English: Hence, ziconotide appears to be mainly eliminated from the CSF (mean t½ = 4.6 hr) by bulk flow of CSF out of the CNS through the arachnoid villi with subsequent transfer into the systemic circulation.
Slovenian: Zato se zdi, da se zikonotid iz cerebrospinalne tekočine v glavnem izloča (t1/2 = 4,6 h) ob prehajanju cerebrospinalne tekočine iz centralnega živčnega sistema preko arahnoidnih resic in tako preide v sistemski krvni obtok.
English: If such is the case, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Slovenian: V takem primeru morate nemudoma obvestiti zdravnika, ker se bo morda odločil za prenehanje zdravljenja z zdravilom Prialt.
English: Respiratory, thoracic and mediastinal disorders dyspnoea respiratory distress
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja dihalna stiska
English: Cognitive and neuropsychiatric adverse reactions are common in patients treated with ziconotide.
Slovenian: Kognitivni in nevropsihiatrični neželeni učinki so pri bolnikih, zdravljenih z zikonotidom, pogosti.
English: To limit the occurrence of serious adverse reactions, a maximum dose of 21.6 μg/day is recommended.
Slovenian: Za omejitev pojava resnih neželenih učinkov znaša največji priporočeni odmerek 21,6 µg/dan.
English: - You should tell your doctor immediately if you experience any of the following symptoms after receiving your treatment; sudden wheeziness, difficulty in breathing, pain in the chest, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
Slovenian: - Nemudoma obvestite zdravnika, če se pri vas po zdravljenju pojavi kateri od naslednjih simptomov: nenadno sopenje, težave pri dihanju, bolečina v prsnem košu, otekanje vek, obraza ali ustnic, izpuščaj ali srbenje (predvsem, kadar se pojavi po vsem telesu).
English: Ziconotide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zikonotida ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.