natgillin/translations-raw huggingface dataset:
In patients with severe chronic pain there is a higher incidence of suicide and suicide attempts than in the general population.
Pri bolnikih z močno kronično bolečino sta samomor in poskus samomora pogostejša kot v splošni populaciji.
Ziconotide may cause confusion, somnolence and other neurological adverse reactions, therefore patients must be advised not to drive or operate machines if affected.
Zikonotid lahko povzroči zmedenost, zaspanost in druge nevrološke neželene učinke, zaradi tega je potrebno bolnike poučiti, da v primeru prizadetosti med zdravljenjem ne smejo voziti ali upravljati strojev.
Alternative dosing regimens including initiation of dosing with lower doses of ziconotide and bolus administration have been explored in a limited number of studies available in the literature.
Alternativne sheme odmerjanja, ki vključujejo uvajanje odmerjanja z manjšimi odmerki zikotonida in uporabo v obliki bolusa, so raziskovali v omejenem številu študij, ki so na voljo v literaturi.
Infections and infestations sepsis, meningitis
Infekcijske in parazitske bolezni sepsa, meningitis
Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to <1/1,000) Very rare (<1/10,000)
Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (<1/10.000).
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ziconotide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zikonotidom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
- If you are receiving chemotherapy please tell your doctor.
- Če prejemate kemoterapijo, obvestite zdravnika.
Your treatment with Prialt will be managed by a doctor who has experience of giving medicines into the space around the spinal cord, and in the use of internal and external infusion pumps.
Vaše zdravljenje z zdravilom Prialt bo izvajal zdravnik, ki ima izkušnje z dajanjem zdravil v prostor okrog hrbtenjače in z uporabo implantacijskih in zunanjih infuzijskih črpalk.
Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
Zikonotid je namenjen zdravljenju hude, kronične bolečine pri odraslih, ki potrebujejo intratekalno (IT) analgezijo.
Most adverse reactions were mild to moderate in severity and resolved over time.
Večina neželenih učinkov je bila blagih do zmernih in so sčasoma izzveneli.
No formal studies assessing the impact of renal or hepatic dysfunction have been conducted; however, given that peptidases are present in various body organs, it is not anticipated that renal or hepatic dysfunction will significantly impact systemic exposure of ziconotide.
Formalnih študij za ocenjevanje disfunkcije ledvic ali jeter niso izvedli; vendar glede na to, da so peptidaze prisotne v raznih telesnih organih, ne pričakujemo, da bi disfunkcija ledvic ali jeter pomembno vplivala na sistemsko izpostavljenost zikonotidu.
The long-term consequences to neuronal function of continuous N-type calcium-channel block have not been demonstrated in experimental animals.
Dolgoročne posledice kontinuiranega zaviranja N-tipa kalcijevih kanalčkov na funkcije nevronov se na poizkusnih živalih niso pokazale.
Do not use this medicine if you notice any discolouration or cloudiness or if particulate matter is observed.
Ne uporabite tega zdravila, če opazite kakšno obarvanost ali motnost ali delce v raztopini.
Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus magus marine snail.
Zikonotid je sintetični analog ω-conopeptida, MVIIA, odkritega v strupu morskega polža Conus magus.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in ovojnini poleg oznake »Uporabno do«.
No accumulation of ziconotide in plasma following long-term IT administration (up to 9 months) has been observed.
Akumulacija zikonotida po dolgotrajni intratekalni aplikaciji (do 9 mesecev) ni bila opažena.
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'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na največji priporočeni intratekalni odmerek (21,6 μg/dan), kar v bistvu pomeni ‘brez natrija'.
How to use Prialt
Kako uporabljati zdravilo Prialt
Given the occurrence of analgesia and adverse reactions at similar doses, the recommended interval between dose increases is 48 hours or more.
Če analgezija in pojav neželenih učinkov nastopita pri podobnih odmerkih, priporočeni interval za zviševanje posameznih odmerkov znaša 48 ur ali več.
The safety of ziconotide administered as a continuous intrathecal infusion has been evaluated in more than 1,400 patients participating in acute and chronic pain clinical trials.
Varnost uporabe zikonotida, apliciranega v obliki kontinuirane intratekalne infuzije, je bila ovrednotena pri preko 1.400 bolnikih, ki so sodelovali v kliničnih študijah o akutni in kronični bolečini.
Treatment with ziconotide should only be undertaken by physicians experienced in intrathecal (IT) administration of medicinal products.
Zdravljenje z zikonotidom naj izvajajo le zdravniki, ki imajo izkušnje z intratekalnim (IT) načinom aplikacije zdravila.
Initial treatment assignment
Načrt začetnega zdravljenja
The median dose at response is approximately 6.0 μg/day and approximately 75% of responsive patients require ≤ 9.6 μg/day.
Mediani odmerek, na katerega se bolniki odzovejo, znaša približno 6,0 µg/dan in približno 75 % odzivnih bolnikov potrebuje ≤ 9,6 µg/dan.
Medicinal products that affect specific peptidases/proteases would not be expected to impact upon ziconotide plasma exposure.
Ni pričakovano, da bi zdravila, ki vplivajo na specifične peptidaze/proteaze, vplivale na raven zikonotida v plazmi.
These effects were defined by exaggerated pharmacological actions of ziconotide and not by neurotoxic lesions or target organ toxicity.
Ti učinki so nastopili kot posledica povečane farmakološke aktivnosti zikonotida in ne kot posledica nevrotoksičnih lezij ali toksičnega učinka na tarčni organ.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
V predkliničnih študijah so opazili učinke le pri izpostavljenostih, ki so dovolj presegale največjo izpostavljenost pri človeku, kar kaže na majhno tveganje pri klinični uporabi.
Although only limited data are available, there is no obvious effect of race, height, weight, gender or age on CSF ziconotide exposure after IT administration.
Čeprav so na razpolago le omejeni podatki, po intratekalni aplikaciji ni opaziti očitnega vpliva rase, višine, teže, spola ali starosti na koncentracijo zikonotida v cerebrospinalni tekočini.
The majority had spinal pain (n = 134), especially failed back surgery (n = 110); a lower proportion had neuropathy (n = 36).
Večina izmed njih je imela bolečine v hrbtenjači (n = 134), zlasti po neuspeli operaciji hrbtenice (n = 110); nižji delež bolnikov je imel nevropatije (n = 36).
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.
Koncentracija zikonotida v raztopini za uporabo z infuzijsko črpalko ne sme biti nižja od 5 µg/ml pri eksterni črpalki in 25 µg/ml pri implantirani črpalki.
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.
Po prehodu v sistemski krvni obtok je pričakovati, da bo zikonotid v prvi vrsti občutljiv na proteolitično cepitev s strani različnih ubikvitarnih peptidaz/proteaz, ki so prisotne v večini organov (npr. v ledvicah, jetrih, pljučih, mišicah, itd.) in tako razgrajen na posamezne peptidne fragmente oziroma posamezne sestavne aminokisline.
Possible long-term local toxic effects on the spinal cord have not been excluded and preclinical data in this respect are limited (see section 5.3).
Možni lokalni toksični učinki na podaljšano hrbtenjačo po dolgoročni uporabi niso bili izključeni, predklinični podatki te vrste so omejeni (glejte poglavje 5.3).
If after starting Prialt you experience a worsening of your depression or have any other symptoms affecting your mood, please inform your healthcare professional.
Če po začetku prejemanja zdravila Prialt opazite pri sebi poslabšanje depresije ali imate kakšne druge simptome, ki vplivajo na vaše razpoloženje, obvestite svojega zdravstvenega delavca.
As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods (see section 4.4).
Ker je nevarnost meningitisa zaradi dolgotrajne kateterizacije intratekalnega prostora večja pri infuzijskem sistemu z zunanjim katetrom, so za dolgotrajno dajanje zikotonida priporočljivi notranji sistemi (glejte poglavje 4.4).
Elevations in creatine phosphokinase were usually asymptomatic.
Zvišanje kreatin fosfokinaze je bilo navadno asimptomatsko.
If you are experiencing depression or have a history of depression please inform your healthcare professional before you are commenced on Prialt.
Če imate depresijo ali anamnezo depresije, o tem obvestite svojega zdravstvenega delavca, preden vam začnejo dajati zdravilo Prialt.
The use of lower doses through continuous administration was demonstrated to achieve efficacy with fewer adverse reactions.
Dokazali so, da se z neprekinjenim dajanjem manjših odmerkov doseže učinkovitost z manj neželenimi učinki.
Patients and physicians must be vigilant for typical symptoms and signs of meningitis (see section 4.4).
Bolniki in zdravniki morajo biti pozorni na tipične simptome in znake meningitisa (glejte poglavje 4.4).
Prialt is used for the treatment of severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain).
Zdravilo Prialt se uporablja za zdravljenje močne, dolgotrajne bolečine pri odraslih, ki potrebujejo zdravilo proti bolečinam z intratekalno injekcijo (injekcija v prostor, ki obdaja hrbtenjačo in možgane).
Only a small number of patients have received systemic chemotherapy and IT ziconotide.
Le malo bolnikov je prejemalo sistemsko kemoterapijo in IT zikonotid.
- Each 1 ml vial contains 100 micrograms; each 2 ml vial contains 200 micrograms; each 5 ml vial contains 500 micrograms.
- Ena 1-ml viala vsebuje 100 mikrogramov učinkovine; ena 2-ml viala vsebuje 200 mikrogramov učinkovine; ena 5-ml viala vsebuje 500 mikrogramov učinkovine.
Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient's analgesic response and adverse reactions.
Začetni odmerek zikonotida znaša 2,4 µg/dan in se titrira individualno za posameznega bolnika glede na bolnikov analgetični odgovor in neželene učinke.
Clinical studies 201 and 202 indicate that the combination of IT ziconotide and IT morphine may effectively reduce pain and decrease systemic opioid use over a sustained period of time for patients whose pain was inadequately controlled with their maximum tolerated dose of IT ziconotide (median 8.7 μg/day, mean 25.7 μg/day - study 201) or with IT morphine (study 202) alone.
Klinični študiji 201 in 202 kažeta, da lahko kombinacija IT zikonotida in IT morfina za dalj časa uspešno olajša bolečino in zmanjša sistemsko uporabo opioidov pri bolnikih, pri katerih se bolečine ni dalo ustrezno obvladovati z najvišjim toleriranim odmerkom IT zikonotida (mediani 8,7 μg/dan, povprečni 25,7 μg/dan - študija 201) ali z IT morfinom samim (študija 202).
Due to the wide distribution of these peptidases it is not expected that hepatic or renal impairment would affect the systemic clearance of ziconotide.
Zaradi razširjenosti teh peptidaz ni pričakovano, da bi okvara jeter ali ledvic vplivala na sistemski očistek zikonotida.
Cardiac disorders atrial fibrillation
Srčne bolezni atrijska fibrilacija
However, in clinical trials it has been observed that patients who tolerate doses of 21.6 μg/day following slow titration over a 3 to 4-week period, generally tolerate higher doses up to 48.0 μg/day.
V kliničnih študijah je bilo ugotovljeno, da bolniki, ki ob počasni 3do 4-tedenski titraciji prenesejo dnevni odmerek 21,6 µg/dan, v splošnem prenesejo tudi višje odmerke do 48,0 µg/dan.
Prialt contains the active substance ziconotide which belongs to a group of medicines, called analgesics or ‘painkillers'.
Zdravilo Prialt vsebuje zdravilno učinkovino zikonotid, ki spada v skupino zdravil, ki se imenujejo analgetiki ali zdravila proti bolečinam.
The concentration of Prialt in a naïve pump may be reduced due to adsorption onto the surfaces of the device, and/or dilution by the residual space of the device.
Koncentracija zdravila Prialt v neizprani črpalki se lahko zmanjša zaradi adsorpcije na površine naprave in/ali razredčitve v rezidualnem prostoru naprave.
However, ziconotide did not induce cell transformation in the in vitro Syrian hamster embryo (SHE) assay and did not increase cell proliferation (pre-neoplastic lesion formation) or apoptosis after subchronic intrathecal exposure in dogs.
Zikonotid in vitro ni induciral transformacije celic na zarodku sirskega hrčka in ni pospešil proliferacije celic (tvorba pre-neoplastičnih lezij) ali apoptoze po subkronični intratekalni aplikaciji pri psih.
What Prialt is and what it is used for What you need to know before you are given Prialt How to use Prialt
Kaj je zdravilo Prialt in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Prialt Kako uporabljati zdravilo Prialt Možni neželeni učinki
Prialt is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravilo Prialt ni priporočljivo v nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Ziconotide may cause or worsen depression with the risk of suicide in susceptible patients.
Zikonotid lahko pri občutljivih bolnikih povzroči ali poglobi depresijo s tveganjem za samomor.
• Rhabdomyolysis (may affect up to 1 in 100 people) - is breakdown of muscle fibres that can lead to kidney damage.
• Rabdomioliza (lahko se pojavi pri največ 1 bolniku od 100 bolnikov) - je razpadanje mišičnih vlaken, ki lahko povzroči okvaro ledvic.
opiate infusion dose should be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates.
Pri bolnikih, ki prenehajo dobivati opiate intratekalno, je potrebno intratekalni infuzijski odmerek opiatov zmanjševati postopoma tekom več tednov in jih zamenjati s farmakološko ekvivalentnim odmerkom peroralnih opiatov.
Changes in neurological signalling have not been studied in experimental animals.
Na poizkusnih živalih niso raziskovali sprememb v nevrološkem prenosu signalov.
The infusion dose rate ranged from 0.03 - 912 μg/day, with a median final dose rate of 7.2 μg/day.
Infuzijski odmerek je znašal od 0,03 do 912 µg/dan, mediani končni odmerek je znašal 7,2 µg/dan.
Based on very limited clinical investigations, both angiotensin converting enzyme inhibitors (e.g., benazepril, lisinopril and moexipril) and HIV protease inhibitors (e.g., ritonavir, saquinavir, indinavir), have no readily apparent effect on plasma ziconotide exposure.
Na osnovi zelo omejenih kliničnih študij tako ACE zaviralci (npr. benazepril, lizinopril in moeksipril) kot tudi zaviralci HIV proteaze (npr. ritonavir, sakvinavir, indinavir) ne izkazujejo jasnega učinka na plazemsko raven zikonotida.
It is unlikely that the degradation products of ziconotide will have significant biological activity, as peptides consisting of the individual peptide loop structures have been found to have binding affinities for N-type voltage sensitive calcium channels that are several orders of magnitude lower than that of the parent (ziconotide) compound.
Ni verjetno, da bi razgradni produkti zikonotida imeli signifikantno biološko aktivnost, saj je bilo ugotovljeno, da imajo peptidi, sestavljeni iz posameznih struktur peptidne zanke, nekajkrat manjšo vezavno afiniteto za N-tip napetostno občutljivih kalcijevih kanalčkov kakor matična spojina (zikonotid).
Elevations in creatine kinase
Zvišanje kreatin kinaze
PHARMACEUTICAL FORM Solution for infusion (infusion).
FARMACEVTSKA OBLIKA Raztopina za infundiranje (infuzija).
- If you notice any adverse change in your thinking, mood or memory, please tell your doctor.
- Če opazite kakršno koli neželeno spremembo v razmišljanju, razpoloženju ali pomnjenju, obvestite zdravnika.
Administration of medicinal products by the intrathecal route carries the risk of potential serious infections, such as meningitis, which may be life threatening.
Intratekalna uporaba zdravil predstavlja tveganje za potencialno resne okužbe, kot je meningitis, ki so lahko življenje ogrožajoče.
Because of this, after the first use of Prialt, the reservoir should be emptied and refilled after 14 days.
Zaradi tega je po prvi uporabi zdravila Prialt po 14 dneh potrebno izprazniti črpalko in jo ponovno napolniti s svežo raztopino.
Lower catheter tip placement, e.g. at the lumbar level, may reduce the incidence of ziconotide-related neurological adverse reactions.
Namestitev konice katetra v nižjem predelu, na primer na nivoju ledvenega dela, lahko zmanjša pogostost z zikonotidom povezanih nevroloških neželenih učinkov.
The medicine will be administered continuously from a pump either implanted into your abdominal wall or placed externally in a belt pouch.
Zdravilo vam bo aplicirano kontinuirano preko črpalke, ki je bodisi vstavljena v vašo trebušno steno ali jo nosite zunanje v posebni vrečki okrog pasu.
The administration of medicinal products by the intrathecal (IT) route carries the risk of potentially serious infections, such as meningitis, which may be life threatening.
Intratekalni (IT) način aplikacije zdravil predstavlja tveganje za potencialno resne okužbe, kot je meningitis, ki so lahko življenje ogrožajoče.
Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; < 0.04 ng/ml).
Plazemske koncentracije po kontinuirani (≥ 48 ur trajajoči) intratekalni infuziji (≤ 21,6 µg/dan) so relativno nizke in tipično nezaznavne (kar pomeni, da okrog 80 % vseh zbranih plazemskih vzorcev bolnikov z bolečino ni vsebovalo merljivih koncentracij zdravila; < 0,04 ng/ml).
hydrochloric acid and sodium hydroxide.
klorovodikova kislina in natrijev hidroksid.
The generated free amino acids are expected to be taken up by cellular carrier systems and either subjected to normal intermediary metabolism or used as substrates for constitutive biosynthetic processes.
Za tako nastale proste aminokisline je pričakovati, da bodo prevzete s strani celičnih prenosnih sistemov in postale bodisi subjekt normalnega intermediarnega metabolizma bodisi substrat za konstitutivne biosintetske procese v celici.
In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
V študijah, kjer so bile uporabljene subkronične kontinuirane intratekalne infuzije na psih in podganah, so bili učinki na obnašanje opaženi pri odmerkih, ki so ≥ 8-krat presegali največji priporočeni klinični intratekalni infuzijski odmerek 21,6 µg/dan (preračunano na mg/kg).
Prialt is given as a very slow continuous injection into the space surrounding the spinal cord (intrathecal use).
Zdravilo Prialt se v obliki zelo počasne kontinuirane injekcije injicira v prostor, ki obdaja hrbtenjačo (intratekalna uporaba).
Unless otherwise noted the table shows the incidence rates of adverse reactions reported in the intrathecal clinical trials with ziconotide (short- and long-term exposure).
Če ni drugače navedeno, preglednica kaže pogostnost pojavljanja neželenih učinkov, o katerih so poročali v kliničnih študijah o intratekalni uporabi zikonotida (kratkotrajna in dolgotrajna izpostavljenost).
Monitoring of creatine phosphokinase is recommended.
Spremljanje kreatin fosfokinaze ¸je priporočljivo.
- If you develop any tenderness in the area around the tube without signs of infection, you should seek advice from your doctor as soon as possible as tenderness may be an early sign of infection.
- Če področje okrog cevke postane občutljivo, ne da bi opazili znake infekcije, čim prej poiščite nasvet zdravnika, ker občutljivost lahko predstavlja zgodnji znak infekcije.
From a microbiological point of view, if the product is diluted it should be transferred to the infusion pump immediately.
Z mikrobiološkega gledišča je potrebno zdravilo v primeru redčenja takoj prenesti v infuzijsko črpalko.
The aetiologies of pain in studies 95-001 (malignant pain) and 96-002 (non-malignant pain) were varied and included bone pain (n = 38) mostly due to bone metastases (n = 34), myelopathy (n = 38), half of whom had spinal cord injury with paralysis (n = 19), neuropathy (n = 79), radiculopathy (n = 24), spinal pain (n = 91) mostly due to failed back surgery (n = 82), and other aetiologies (n = 82).
Etiologija bolečine v študiji 95-001 (maligna bolečina) in 96-002 (nemaligna bolečina) je bila različna in je vključevala bolečine v kosteh (n = 38), večinoma zaradi kostnih metastaz (n = 34), mielopatijo (n = 38), polovica jih je imela poškodbo hrbtenjače s paralizo (n = 19), nevropatijo (n = 79), radikulopatijo (n = 24), bolečine v hrbtenici (n = 91), večinoma kot posledico neuspele operacije hrbtenice (n = 82) in druge etiologije (n = 82).
Chemical and physical in use stability has been demonstrated for 60 days at 37°C.
Kemična in fizikalna stabilnost med uporabo znaša 60 dni pri 37 °C.
There are no or limited amount of data from the use of ziconotide in pregnant women.
Podatkov o uporabi zikonotida pri nosečnicah ni ali pa so omejeni.
Meningitis due to the entrance of organisms along the catheter track or inadvertent contamination of the infusion system is a known complication of intrathecal medicinal product administration, especially with external systems.
Meningitis, do katerega pride zaradi vstopa mikroorganizmov preko katetra ali nenamerne kontaminacije infuzijskega sistema je poznana komplikacija intratekalnega načina aplikacije zdravil, zlasti ob uporabi eksternih kateterskih sistemov.
- You may experience drowsiness or may not be fully aware of your surroundings whilst receiving treatment.
- Med prejemanjem zdravila utegnete občutiti dremavost ali pa se morda ne boste popolnoma zavedali svoje okolice.
• Coma (may affect up to 1 in 100 people) - a state of unconsciousness with difficulty responding or waking up.
• Koma (lahko se pojavi pri največ 1 bolniku od 100 bolnikov) - je stanje nezavesti, v kateri se bolnik s težavo odziva ali zbudi.
Chemical and physical in-use stability has been demonstrated for 14 days at 37ºC in the Synchromed pump when the pump has not previously been exposed to the medicinal product.
Kemična in fizikalna stabilnost med uporabo raztopine znaša 14 dni pri 37 °C pri uporabi Synchromed črpalke, ki predhodno še ni bila v stiku z zdravilom.
• Meningitis (may affect up to 1 in 100 people) - is inflammation of the coverings of the brain and spinal cord usually caused by an infection.
• Meningitis (lahko se pojavi pri največ 1 bolniku od 100 bolnikov) - je vnetje možganskih in hrbtenjačnih ovojnic, ki ga navadno povzroči okužba.