FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U bolesnika koji prime prekomjernu dozu potrebno je primjenjivati opće potporne mjere liječenja sve dok se ne povuku pretjerani farmakološki učinci lijeka.
English: Ziconotide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti zikonotid tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Ziconotide appears to distribute mainly within the CSF until transferred to the systemic circulation.
Croatian: Čini se da se zikonotid raspodjeljuje uglavnom u cerebrospinalnoj tekućini dok ne dospije u sistemsku cirkulaciju.
English: It is recommended that patients undergo a neuropsychiatric evaluation before and after starting intrathecal ziconotide (see section 4.4).
Croatian: Preporučuje se neuropsihijatrijska procjena bolesnika prije i poslije početka primjene intratekalnog zikonotida (vidjeti dio 4.4).
English: There are no or limited amount of data from the use of ziconotide in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni zikonotida u trudnica ograničeni.
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)).
Croatian: Obavijestite liječnika ako uzimate, ako ste nedavno uzeli ili biste mogli uzeti neki drugi lijek (npr. baklofen za liječenje spazma mišića, klonidin za liječenje visokog krvnog tlaka, bupivakain za lokalnu anesteziju, morfij za bol, propofol za opću anesteziju ili neki drugi lijek koji se primjenjuje intratekalnom injekcijom (injekcija koja se daje u prostor oko kralježnične moždine i mozga)).
English: Following passage into the systemic circulation, ziconotide is expected to be primarily susceptible to proteolytic cleavage by various ubiquitous peptidases/proteases present in most organs (e.g., kidney, liver, lung, muscle, etc.), and thus degraded to peptide fragments and its individual constituent free amino acids.
Croatian: Nakon ulaza u sistemsku cirkulaciju, očekuje se da će zikonotid biti prvenstveno osjetljiv na proteolitičko cijepanje od strane različitih ubikvitarnih peptidaza/proteaza prisutnih u većini organa (npr. bubreg, jetra, pluća, mišići itd.) pa stoga razgrađen na fragmente peptida i njihove sastavne pojedinačne slobodne aminokiseline.
English: Nervous system adverse reactions, particularly dizziness, nausea and abnormal gait appear to be correlated with CSF exposure, though a definitive relationship has not been established.
Croatian: Nuspojave živčanog sustava, osobito omaglica, mučnina i poremećen hod čini se da su u korelaciji s izloženošću cerebrospinalne tekućine, iako točan odnos nije ustanovljen.
English: The maximum recommended intrathecal dose is 21.6 μg/day.
Croatian: Najveća preporučena intratekalna doza iznosi 21,6 μg/dan.
English: Patients and physicians must be vigilant for typical symptoms and signs of meningitis (see section 4.4).
Croatian: Bolesnici i liječnici trebaju pozorno pratiti moguću pojavu simptoma i znakova meningitisa (vidjeti dio 4.4).
English: Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni iznosi 60 dana pri 37°C.
English: PHARMACEUTICAL FORM Solution for infusion (infusion).
Croatian: OBLIK Otopina za infuziju (infuzija).
English: Patients should be titrated in dose increments of ≤ 2.4 μg/day, up to a maximum dose of 21.6 μg/day.
Croatian: Titraciju u bolesnika treba provoditi u povećanjima doze od ≤ 2,4 μg/dan, do najviše doze od 21,6 μg/dan.
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.
Croatian: Ako primite više lijeka Prialt nego što je to odredio liječnik, možda se nećete osjećati dobro uz znakove kao što su smetenost, teškoće s govorom, otežano nalaženje pravih riječi, prekomjerno drhtanje, ošamućenost, pretjerana pospanost, osjećaj mučnine ili povraćanje.
English: Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.
Croatian: Liječenje zikonotidom trebaju provoditi samo liječnici s iskustvom u intratekalnoj primjeni lijekova.
English: No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.
Croatian: Nema podataka o istodobnoj primjeni djelomičnih opioidnih agonista (npr. buprenorfina) i zikonotida.
English: Elevations in creatine kinase, which are usually asymptomatic, are common amongst patients on intrathecal ziconotide.
Croatian: Povišenje kreatin kinaze, koje je obično asimptomatsko, često je među bolesnicima koji primaju intratekalni zikonotid.
English: The concentration of the solution used in the infusion pump must be no lower than 5 μg/ml ziconotide in an external pump and 25 μg/ml in an internal pump.
Croatian: Koncentracija otopine primijenjene infuzijskom pumpom ne smije biti manja od 5 μg/ml zikonotida u vanjskoj pumpi i 25 μg/ml u unutarnjoj pumpi.
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.
Croatian: Farmakokinetika zikonotida u cerebrospinalnoj tekućini ispitana je nakon jednosatnih intratekalnih infuzija od 1 do 10 μg zikonotida u bolesnika s kroničnom boli.
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.
Croatian: U vezanju za te neuronalne blokatore kalcijevih kanala N-tipa, zikonotid inhibira o naponu ovisan protok kalcija u primarna nociceptivna aferentna živčana vlakna koja završavaju u površinskim slojevima stražnjeg roga kralježnične moždine.
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).
Croatian: • Anafilaktička reakcija (nije poznato u koliko se osoba može javiti) - teška alergijska reakcija čiji su znakovi iznenadno piskanje, otežano disanje, bol u prsnom košu, oticanje kapaka, lica ili usana, osip ili svrbež (osobito po cijelom tijelu).
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.
Croatian: - Ako primate Prialt s pomoću pumpe koju nosite izvan tijela, važno je da jednom dnevno provjerite da se na mjestu gdje Vam cjevčica ulazi u tijelo nisu pojavili znakovi infekcije.
English: Symptoms of meningitis are headache, stiff neck, dislike of bright lights, fever, vomiting, confusion and drowsiness.
Croatian: Simptomi meningitisa su glavobolja, ukočen vrat, nepodnošenje jarkog svjetla, vrućica, povraćanje, smetenost i omamljenost.
English: Ziconotide (n = 169)b
Croatian: Zikonotid (n = 169)b
English: Ziconotide (n = 71)
Croatian: Zikonotid (n = 71)
English: - Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
Croatian: - Jedna bočica od 1 ml sadrži 100 mikrograma; jedna bočica od 2 ml sadrži 200 mikrograma;
English: However, monitoring of creatine kinase is recommended.
Croatian: Ipak, preporučuje se praćenje kreatin kinaze.
English: C. OTHER CONDITIONS AND REQUIREMENTSOF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Each vial contains 20 ml solution for infusion.
Croatian: Jedna bočica sadrži 20 ml otopine za infuziju.
English: Investigations blood creatine phosph okinase increase d, weight decreased electrocardiogram abnormal, aspartate aminotransferase increased, blood creatine phosphokinase MM increased, body temperature increased a. From spontaneous reporting
Croatian: Pretrage povišena kreatin fosfokinaza u krvi, smanjenje tjelesne težine abnormalnosti u elektrokardiogram u, povišena aspartat aminotransferaza, povišena kreatin fosfokinaza skeletnih mišića u krvi, povišena tjelesna temperatura a Iz spontanih prijava
English: Eye disorders vision blurred diplopia, visual disturbance, photophobia
Croatian: Poremećaji oka zamagljen vid diplopija, smetnje vida, fotofobija
English: Withdrawal of concomitant CNS depressant medicinal products should also be considered as they may contribute to the reduced level of arousal.
Croatian: Također treba razmisliti o povlačenju istodobno primjenjivanih lijekova depresanata središnjeg živčanog sustava jer oni mogu pridonijeti smanjenju razine budnosti.
English: Stability has been demonstrated for 21 days at room temperature in the CADD-Micro pump.
Croatian: U pumpi CADD-Micro dokazana je stabilnost u trajanju od 21 dan na sobnoj temperaturi.
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.
Croatian: Stoga se, izgleda, zikonotid uglavnom eliminira iz cerebrospinalne tekućine (srednje t½ = 4,6 h) prijelazom cerebrospinalne tekućine iz središnjeg živčanog sustava preko arahnoidnih resica uz posljedični prijelaz u sistemsku cirkulaciju.
English: Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.
Croatian: Kognitivne i neuropsihijatrijske nuspojave, posebice smetenost, česte su u bolesnika liječenih zikonotidom.
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.
Croatian: Ako unatoč primjeni Prialta i dalje osjećate jaku bol ili smatrate da su nuspojave prevelike, obratite se liječniku.
English: Ziconotide (n = 112)
Croatian: Zikonotid (n = 112)
English: To limit the occurrence of serious adverse reactions, a maximum dose of 21.6 μg/day is recommended.
Croatian: Da bi se ograničila pojava ozbiljnih nuspojava preporučuje se maksimalna doza od 21,6 μg/dan.
English: One vial per carton.
Croatian: Jedna bočica u kutiji.
English: Ziconotide is contraindicated in combination with IT chemotherapy (see section 4.3).
Croatian: Zikonotid je kontraindiciran u kombinaciji s intratekalnim oblikom kemoterapije (vidjeti dio 4.3).
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.
Croatian: - Ako primate Prialt preko pumpe koju nosite izvan tijela, i na nekom se mjestu prekine spoj infuzijskih cjevčica, odmah se javite liječniku ili medicinskoj sestri.
English: Cognitive and neuropsychiatric adverse reactions are common in patients treated with ziconotide.
Croatian: Kognitivne i neuropsihijatrijske nuspojave česte su u bolesnika liječenih zikonotidom.
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.
Croatian: Srednja vrijednost Medijan Raspon aBolesnici s odgovorom definirani su kao bolesnici koji su: 1) imali pad ≥ 30% u rezultatu VASPI u usporedbi s onim prije liječenja; 2) primali su stabilnu ili smanjenu dozu opioidnih analgetika; i 3) vrsta opioida im nije promijenjena ako su ih primali prije infuzije.
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.
Croatian: Zikonotid je peptid relativno male molekularne težine (MW = 2639) i filtrira se u bubrežnom glomerulu ali samo minimalne količine zikonotida (< 1%) nađu se u urinu nakon intravenske infuzije.
English: Mean ziconotide CL (0.38 ml/min) approximates adult human CSF turnover rate (0.3 - 0.4 ml/min).
Croatian: Srednja vrijednost klirensa zikonotida (0,38 ml/min) odgovara brzini obnavljanja cerebrospinalne tekućine u odraslih osoba (0,3 - 0,4 ml/min).
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.
Croatian: Moguće je intratekalni zikonotid dodavati stabilnim dozama intratekalnog morfina (vidjeti dio 5.1), ali zahtijeva posebnu pozornost jer je u ispitivanju 202, iako je doza zikonotida bila mala, opažena velika stopa neuropsihijatrijskih nuspojava (smetenost/poremećeno mišljenje, paranoidne reakcije i halucinacije te poremećen hod) od kojih su neke bile ozbiljne.
English: No clinical data are available on the interaction between IT chemotherapy and IT ziconotide.
Croatian: Nema dostupnih kliničkih podataka o interakciji intratekalnog oblika kemoterapije i intratekalno primijenjenog zikonotida.
English: - If you are receiving chemotherapy please tell your doctor.
Croatian: - Molimo obavijestite liječnika ako primate kemoterapiju.
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).
Croatian: - Ako nakon primljene terapije osjetite neki od sljedećih simptoma, odmah obavijestite liječnika: iznenadno piskanje, otežano disanje, bol u prsnom košu, oticanje kapaka, lica ili usana, osip ili svrbež (osobito po cijelom tijelu).
English: Specific clinical medicinal product interaction studies have not been conducted with ziconotide.
Croatian: Nisu provedena posebna klinička ispitivanja interakcija drugih lijekova sa zikonotidom.
English: Prior to initiation of therapy, an internal pump must be rinsed three times with 2 ml of Prialt at 25 μg/ml.
Croatian: Prije početka terapije, unutarnju pumpu treba isprati tri puta s 2 ml Prialta u koncentraciji od 25 μg/ml.
English: Sodium chloride Water for injections Hydrochloric acid (pH adjuster) Sodium hydroxide (pH adjuster)
Croatian: 6.1 Popis pomoćnih tvari metionin natrijev klorid voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.5).
Croatian: Potreban je oprez kad se zikonotid primjenjuje u bolesnika koji primaju sistemsku kemoterapiju (vidjeti dio 4.5).
English: If such is the case, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Croatian: Ako je to slučaj, morate odmah obavijestiti svog liječnika jer će možda odlučiti prekinuti Vaše liječenje lijekom Prialt.
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).
Croatian: U ispitivanju plodnosti mužjaka i ženki štakora nisu opaženi učinci u mužjaka dok su u ženki opažena smanjenja žutog tijela, mjesta implantacije i broja živih embrija (vidjeti dio 5.3).
English: Caution should be exercised when ziconotide is administered to patients who are receiving systemic chemotherapy (see section 4.4).
Croatian: Potreban je oprez kad se zikonotid primjenjuje u bolesnika koji primaju sistemsku kemoterapiju (vidjeti dio 4.4).
English: In-use shelf-life (diluted product) Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Croatian: Rok valjanosti u primjeni (razrijeđeni lijek) Dokazana kemijska i fizikalna stabilnost u primjeni iznosi 60 dana pri 37°C.
English: Ear and labyrinth disorders vertigo, tinnitus
Croatian: Poremećaji uha i labirinta vrtoglavica, tinitus
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).
Croatian: U slučaju progresivnog ili značajnog povišenja kreatin fosfokinaze povezanog s kliničkom slikom miopatije ili rabdomiolize potrebno je razmotriti obustavu zikonotida (vidjeti dio 4.4).
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.
Croatian: Vrlo često (mogu se javiti u više od 1 korisnika na 10) Smetenost, omaglica, zamagljen vid, glavobolja, brzo pomicanje očiju lijevo-desno, gubitak ili oštećeno pamćenje (zaboravljivost), povraćanje, mučnina, opća slabost i pospanost.
English: Lower catheter tip placement, e.g. at the lumbar level, may reduce the incidence of ziconotide-related neurological adverse reactions.
Croatian: Uvođenje vrha katetera niže, npr. u predjelu slabinskog dijela leđa može smanjiti incidenciju neuroloških nuspojava povezanih sa zikonotidom.
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.
Croatian: U nekih bolesnika koji su primili intratekalne doze veće od najviše preporučene doze opaženi su pretjerani farmakološki učinci, npr. ataksija, nistagmus, omaglica, stupor, snižena razina svijesti, spazam mišića, stanje smetenosti, sedacija, hipotenzija, afazija, poremećaj govora, mučnina i povraćanje.
English: Respiratory, thoracic and mediastinal disorders dyspnoea respiratory distress
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja respiratorni distres
English: Combination with IT chemotherapy (see section 4.5).
Croatian: Kombinacija s intratekalnim oblikom kemoterapije (vidjeti dio 4.5).
English: Studies have not been conducted in patients with impaired hepatic function.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenom funkcijom bubrega.
English: There were three placebo-controlled clinical trials of IT ziconotide.
Croatian: Provedena su tri placebom kontrolirana ispitivanja s intratekalnim zikonotidom.
English: If this happens, you should immediately notify your doctor, as he/she may decide to halt your Prialt treatment.
Croatian: Ako se to dogodi, odmah obavijestite svog liječnika jer će možda odlučiti prekinuti Vaše liječenje lijekom Prialt.
English: Skin and subcutaneous tissue disorders pruritus, sweating increased rash
Croatian: Poremećaji kože i potkožnog tkiva pruritus, pojačano znojenje osip
English: Vascular disorders orthostatic hypotensi on, hypotension
Croatian: Krvožilni poremećaji ortostatska hipoten zija, hipotenzija
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.
Croatian: Kada se intratekalni zikonotid dodaje stabilnim dozama intratekalnog morfina mogu se, kao i kod započinjanja monoterapije intratekalnog zikonotida, pojaviti psihotične nuspojave (npr. halucinacije, paranoidne reakcije) ili povećanje nuspojava može zahtijevati prekid primjene (vidjeti dio 4.5).
English: No specific studies with ziconotide in humans have been conducted to evaluate effects on fertility.
Croatian: Specifična ispitivanja u svrhu procjene učinaka zikonotida na plodnost u ljudi nisu provedena.
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
Croatian: Ne smijete primati Prialt - ako ste alergični na zikonotid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako primate lijek protiv karcinoma u prostor oko kralježnične moždine.
English: CSF and Plasma Pharmacokinetics of Ziconotide [mean ± SD (median)]
Croatian: Farmakokinetika zikonotida u cerebrospinalnoj tekućini i u plazmi [srednja vrijednost ± SD (medijan)]
English: Symptoms of rhabdomyolysis are abnormal urine colour (brown coloured), reduced urine production, muscle weakness, muscle aching and muscle tenderness.
Croatian: Simptomi rabdomiolize su neuobičajena boja mokraće (smeđe boje), smanjeno stvaranje mokraće, slabost mišića, tupa bol u mišićima i osjetljivost mišića.
English: Within each frequency grouping undesirable effects are presented in order of decreasing frequency.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane redoslijedom prema padajućoj učestalosti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per maximum recommended intrathecal dose (21.6 μg/day), i.e. essentially ‘sodium- free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija u najvećoj preporučenoj intratekalnoj dozi
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.
Croatian: Doza na kraju titracije (μg/h) Srednja vrijednost Medijan Raspon aBolesnici s odgovorom bili su definirani kao bolesnici koji su imali pad ≥ 30% u rezultatu VASPI u usporedbi s onim prije liječenja.
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.
Croatian: U bolesnika liječenih zikonotidom zabilježene su epizode akutnih psihijatrijskih poremećaja kao što su halucinacije, paranoidne reakcije, neprijateljsko ponašanje, agresivnost, delirij, psihoza i manične reakcije.
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.
Croatian: Kad su potrebne male doze zikonotida, npr. kad se započinje titracija, zikonotid se mora prije primjene razrijediti 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za injekciju bez konzervansa.
English: 500 micrograms/20ml
Croatian: 500 mikrograma/20 ml
English: Marketing Authorisation Holder: RIEMSER Pharma GmbH An der Wiek 7
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: RIEMSER Pharma GmbH An der Wiek 7
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 25 μg ziconotide (as acetate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 25 μg zikonotida (u obliku zikonotidacetata).
English: Gastrointestinal disorders nausea, vomiting diarrhoea, dry mouth, constipation, nausea aggravated, upper abdominal pain dyspepsia
Croatian: Poremećaji probavnog sustava mučnina, povraćanje proljev, suha usta, konstipacija, pogoršanje mučnine, bol u gornjem dijelu abdomena dispepsija
English: EU/1/04/302/003 - 5 ml solution for infusion.
Croatian: EU/1/04/302/003 - 5 ml otopina za infuziju
English: - The other ingredients are methionine, sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.
Croatian: - Ostali su sastojci metionin, natrijev klorid, voda za injekcije, kloridna kiselina i natrijev hidroksid.