natgillin/translations-raw huggingface dataset:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Toviaz. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Toviaz, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment. 
Glavno merilo učinkovitosti je bila sprememba števila uriniranj v 24 urah po 12 tednih zdravljenja.
For more information about treatment with Toviaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Toviaz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
One of the studies also compared Toviaz with tolterodine (another medicine used in overactive bladder syndrome). 
V eni izmed študij so primerjali zdravilo Toviaz tudi s tolterodinom (drugim zdravilom, ki se uporablja pri sindromu čezmerno aktivnega sečnega mehurja).
In the bladder, this causes the muscles that push urine out of the bladder to relax, leading to an increase in the capacity of the bladder and to changes in the way the bladder muscles contract as the bladder fills up. 
Zaradi tega se mišice v sečnem mehurju, ki potiskajo urin iz njega, sprostijo, kar vodi k povečanju prostornine sečnega mehurja in spremembi načina krčenja mišic mehurja med njegovim polnjenjem.
Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination). 
Zdravilo Toviaz se uporablja za zdravljenje naslednjih simptomov pri odraslih s sindromom čezmerno aktivnega sečnega mehurja: povečane pogostnosti uriniranja (potrebe po pogostem uriniranju), urgentne mikcije (nenadne potrebe po uriniranju) in urgentne inkontinence (nenadne izgube nadzora nad uriniranjem).
What is the risk associated with Toviaz? 
Kakšna tveganja so povezana z zdravilom Toviaz?
The active substance in Toviaz, fesoterodine, is an anticholinergic medicine. 
Zdravilna učinkovina zdravila Toviaz, fesoterodin, je antiholinergično zdravilo.
Toviaz is a medicine containing the active substance fesoterodine. 
Toviaz je zdravilo, ki vsebuje zdravilno učinkovino fesoterodin.
Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines. 
Zdravilo Toviaz se bolnikom z zmernim obolenjem jeter ali z zmernim do hudim obolenjem ledvic ne sme dajati sočasno z močnimi zaviralci CYP3A4.
• severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding); 
• hudim ulceroznim kolitisom (hudim vnetjem debelega črevesa, ki povzroča razjede in krvavitve);
Why has Toviaz been approved? 
Zakaj je bilo zdravilo Toviaz odobreno?
Toviaz must not be used in people who are hypersensitive (allergic) to fesoterodine, to any of the other ingredients, to peanut or to soya. 
Zdravila Toviaz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) fesoterodin, katero koli drugo sestavino zdravila, arašide ali sojo.
• myasthenia gravis (a disease of the nerves causing muscle weakness); 
• miastenijo gravis (boleznijo živčevja, ki povzroča šibkost mišic);
• urinary retention (difficulty in passing urine); 
• retencijo urina (težavami z izpraznitvijo sečnega mehurja);
It is available as prolonged-release 4 mg tablets and 8 mg tablets. 
Na voljo je v obliki 4- in 8-miligramskih tablet s podaljšanim sproščanjem.
Toviaz was more effective than placebo and as effective as tolterodine in reducing the number of times the patients urinated in a 24-hour period. 
Zdravilo Toviaz je bilo pri zmanjševanju števila uriniranj v 24 urah učinkovitejše od placeba in enako učinkovito kot tolterodin.
For the full list of all side effects reported with Toviaz, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Toviaz, glejte navodilo za uporabo.
The reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively. 
Pri bolnikih, ki so jemali placebo, se je število uriniranj zmanjšalo za 1,02, pri tistih, ki so prejemali tolterodin, pa za 1,69.
The tablets are swallowed whole with a glass of water and must not be chewed. 
Priporočeni začetni odmerek zdravila Toviaz je 4 mg enkrat na dan. Tablete je treba pogoltniti cele in jih poplakniti s kozarcem vode; nikakor se jih ne sme žvečiti.
• severe hepatic impairment (severe liver disease); 
• hudo okvaro jeter (hudim obolenjem jeter);
What is Toviaz? 
Kaj je zdravilo Toviaz?
How has Toviaz been studied? 
Kako je bilo zdravilo Toviaz raziskano?
The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment). 
Zdravilo Toviaz (4 ali 8 mg dnevno) so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, ki sta vključevali 1 964 bolnikov s čezmerno aktivnim sečnim mehurjem.
What is Toviaz used for? 
Za kaj se zdravilo Toviaz uporablja?
How does Toviaz work? 
Kako zdravilo Toviaz deluje?
The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors', a group of medicines that may affect the way Toviaz is broken down in the body. 
Pri bolnikih, ki imajo težave z ledvicami ali jetri, zlasti če sočasno jemljejo zaviralce CYP3A4, tj. skupino zdravil, ki utegnejo vplivati na razgradnjo zdravila Toviaz v telesu, je treba odmerek zdravila prilagoditi ali pa ga sploh ne uporabljati.
How is Toviaz used? 
Kako se zdravilo Toviaz uporablja?
The key elements of these educational materials will be the following: 
Ključne točke teh izobraževalnih gradiv bodo sledeče:
The Marketing Authorisation Holder shall agree the format and content of the above materials with the National Competent Authority of each Member State. 
Imetnik dovoljenja za promet mora obliko in vsebino zgoraj opisanih materialov uskladiti z nacionalnimi pristojnimi oblastmi vsake države članice.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO
• Information on how the KRAS testing should be appropriately conducted 
• Informacija o tem, kako se testiranje za stanje KRAS primerno izvede.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe Vectibix are provided with educational materials informing them of the importance of KRAS ascertainment before treatment with panitumumab. 
Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, od katerih se pričakuje predpisovanje zdravila Vectibix, prejeli izobraževalna gradiva, ki jih bodo informirala o pomembnosti določitve KRAS pred zdravljenjem s panitumumabom.
• Brief introduction to the Vectibix indication and the purpose of this tool 
• Kratka predstavitev indikacij zdravila Vectibix in namen tega orodja.
• Brief introduction to KRAS and its role in the panitumumab mechanism of action 
• Kratka predstavitev KRAS in njegove vloge pri mehanizmu delovanja panitumumaba.
• Recommendation that Vectibix: o should only be used in patients whose tumours are wild-type KRAS o should not be used as monotherapy or in combination with FOLFIRI in patients whose tumours are mutant KRAS or patients whose tumours have not been tested for KRAS status o is contraindicated in combination with FOLFOX in patients with mutant KRAS tumours or in patients with unknown KRAS tumour status 
o se zdravilo Vectibix lahko uporablja samo pri bolnikih, ki imajo tumorje z divjim tipom KRAS, o se zdravilo Vectibix ne sme uporabljati kot monoterapija ali v kombinaciji s FOLFIRI pri bolnikih, ki imajo tumorje z mutantnim KRAS ali bolnikih, ki niso bili testirani za stanje KRAS, o je zdravilo Vectibix kontraindicirano v kombinaciji s FOLFOX pri bolnikih s tumorji z mutantnim KRAS ali pri bolnikih s tumorjem z neznanim stanjem KRAS.
• Information that in patients with mutant KRAS tumours panitumumab has shown a detrimental effect in combination with FOLFOX and no effect as monotherapy and in combination with FOLFIRI 
FOLFOX pokazal škodljiv učinek, panitumumab kot monoterapija in panitumumab v kombinaciji s FOLFIRI pa ni pokazal učinka.
(in EEA) 
(v EGP)
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Solution for sealant Intralesional use 
Raztopina za lepilo Intralezijska uporaba
QUIXIL solution for sealant 
QUIXIL raztopina za lepilo
Fibronectin, human: 30 mg Human fibrinogen: 30 mg Arginine hydrochloride 19 mg Acidum tranexamicum 95 mg Glycine 7,9 mg Sodium chloride 7 mg 
Fibronektin, humani: 30 mg Humani fibrinogen: 30 mg Arginin hidroklorid: 19 mg Traneksaminska kislina: 95 mg Glicin: 7,9 mg
Tranexamic acid 85 mg/ml -105mg /ml 2nd Component (Thrombin) Thrombin 800 IU /ml - 1200 IU /ml Calcium chloride: 5,6 mg/ml - 6,2 mg /ml 
Fibrinogen-fibronektin: 40 mg/ml-60 mg/ml Traneksaminska kislina: 85 mg/ml-105 mg/ml 2. komponenta (trombin) Trombin: 800 IE/ml-1200 IE/ml Kalcijev klorid: 5,6 mg/ml-6,2 mg/ml
Clottable protein conc: 50mg/ml Thrombin: 1000 IU/ml Calcium chloride: 5.9 mg/ml Tranexamic acid: 95mg/ml 
Kalcijev klorid: 5,9 mg/ml Traneksaminska kislina: 95 mg/ml
Thrombin: 800 IU/ml -1,200 IU/ml Calcium Chloride: 5.6 mg/ml - 6.2 mg/ml 
Fibrinogen in fibronektin: 40 mg/ml-60 mg/ml Traneksaminska kislina: 85 mg/ml-105 mg/ml Trombin: 800 IE/ml-1200 IE/ml Kalcijev klorid: 5,6 mg/ml-6,2 mg/ml
Adults (including the elderly ≥ 65 years of age) 
Odrasli (vključno s starejšimi od 65 let)
Not known (cannot be estimated from the available data) 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In addition, you may also occasionally experience muscular problems. 
Poleg tega boste morda imeli občasno težave z mišicami.
These may be signs of a severe allergic reaction. 
To bi lahko bili znaki težke alergijske reakcije.
However, in view of limited data, the development of tolerance cannot be excluded. 
Vendar na osnovi omejenih podatkov razvoja tolerance ni mogoče izključiti.
Depression of Central Nervous System (CNS) 
Depresija centralnega živčnega sistema (CŽS)
Risk of infection 
Nevarnost okužbe
An external catheter system should only be used when an internal system cannot be implanted. 
Sistem z zunanjim katetrom smemo uporabiti le, kadar notranjega sistema ni mogoče implantirati.
The initial fill must therefore be replaced after 14 days. 
Začetno polnitev je torej potrebno zamenjati po 14 dneh.
In case of a need for long term treatment, monitoring may be necessary (as decided by your doctor). 
V primeru potrebe po dolgoročnem zdravljenju bo morda potrebno spremljanje (o tem bo odločil zdravnik).
The technical data are given only for information and should not limit health-care providers' choice. 
Tehnični podatki so navedeni samo v informacijo in ne smejo ovirati izbire zdravstvenega delavca.
Subsequently the pump should be emptied and refilled every 60 days. 
Nato je potrebno črpalko izprazniti in ponovno napolniti vsakih 60 dni.
Combination studies with IT Morphine 
Kombinirane študije z IT morfinom
Specific instructions for using the pumps must be obtained from the manufacturer. 
Specifična navodila za uporabo črpalk mora zagotoviti njen izdelovalec.
The efficacy of IT ziconotide in study 301 was lower than in the previous two, short-term studies. 
Učinkovitost intratekalno aplicirnega zikonotida v študiji 301 je bila nižja kot v prejšnjih dveh kratkoročnih študijah.
The patient usually remains conscious and breathing is not depressed. 
Bolnik običajno ostane pri zavesti in dihanje ni zavirano.
Therefore, pharmacological effects related to systemic exposure should be minimal. 
Zaradi tega bi morali biti farmakološki učinki, povezani s sistemsko izpostavljenostjo zdravilu, minimalni.
These studies suggest that these alternative methods of administration of ziconotide may be possible however, due to the limited numbers of patients, these results are inconclusive and there is currently insufficient evidence available to make definitive recommendations for such alternative dosing regimens. 
Te študije kažejo, da so te alternativne metode dajanja zikonotida sicer možne, vendar so zaradi omejenih števil bolnikov ti rezultati neprepričljivi in trenutno ni na voljo dovolj dokazov, ki bi omogočili dokončna priporočila za take alternativne sheme odmerjanja.
What Prialt is and what it is used for 
Kaj je zdravilo Prialt in za kaj ga uporabljamo
At the start of your treatment your doctor may increase your dose every 1 to 2 days or more. 
Na začetku zdravljenja bo zdravnik morda povišal vaš odmerek na vsake 1-2 dni ali več.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2005 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2005 Datum zadnjega podaljšanja: 18. september 2014
In clinical trials, 88% of patients experienced adverse reactions. 
V kliničnih študijah je 88 % bolnikov izkazalo neželene učinke.
Many responsive patients obtain near-maximal analgesia within a few hours of delivery of an appropriate dose. 
Mnogo odzivnih bolnikov doseže skoraj maksimalno analgezijo v nekaj urah prejemanja ustreznega odmerka zdravila.
There was no indication of respiratory depression. 
Znakov zaviranja dihanja ni bilo.
Other medicines and Prialt 
Druga zdravila in zdravilo Prialt
The median exposure time was 43 days. 
Mediano trajanje zdravljenja je znašalo 43 dni.
Respondera n (%) 
Odzivni bolnikia n (%)
What you need to know before you are given Prialt 
Kaj morate vedeti, preden boste prejeli zdravilo Prialt
However, the potential for severe allergic reactions cannot be excluded and spontaneous reports of anaphylactic reactions have been received. 
Kljub temu ni mogoče izključiti možnosti nastanka resnih alergijskih reakcij in pojavila so se spontana poročila o anafilaktičnih reakcijah.
Therefore, caution is needed during long-term treatment. 
Zaradi tega je ob dolgoročni uporabi potrebna previdnost.
Dose at end of titration (μg/hr) 
Odmerek na koncu titracije (μg/hr)
44b 17489 Greifswald Germany 
44b 17489 Greifswald Nemčija
Efficacy results from study 96-002 
Rezultati učinkovitosti v študiji 96-002
Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤ 9.6 μg/day. 
Približno 75 % bolnikov, ki zadovoljivo odgovorijo na zdravljenje, potrebuje odmerek, ki je ≤ 9,6 µg/dan.
The safety and efficacy of ziconotide in children aged 0 to 18 years have not been established. 
Varnost in učinkovitost zikonotida pri otrocih, starih 0 do 18 let, nista bili dokazani.
CL = clearance; Vd = distribution volume; t½ = half life 
CL = očistek; Vd = volumen porazdelitve; t½ = razpolovni čas
Only five had malignant pain. 
Samo pet izmed njih je trpelo zaradi maligne bolečine.
Ziconotide has moderate influence on the ability to drive and use machines. 
Zikonotid ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
The duration of treatment has ranged from one-hour bolus infusion to continuous use for more than 6 years. 
Razpon trajanja zdravljenja je segal od enourne bolusne infuzije do kontinuirane aplikacije v trajanju več kakor 6 let.
All patients in the 301 study had failed IT therapy with combinations of analgesics and their physicians considered that 97% of the patients were refractory to currently available treatments. 
Nihče izmed bolnikov, sodelujočih v študiji 301, se ni odzival na zdravljenje z intratekalno kombinacijo analgetikov in njihovi zdravniki so bili mnenja, da se jih 97 % ne odziva na trenutno razpoložljivo zdravljenje.
If this happens, consult your doctor or hospital immediately. 
Če pride do tega, se nemudoma posvetujte z zdravnikom ali odidite v bolnišnico.
Pharmacotherapeutic group: Analgesics, other analgesics and antipyretics, ATC code: N02BG08 
Farmakoterapevtska skupina: Analgetiki, drugi analgetiki in antipiretiki, oznaka ATC: N02BG08
Your doctor will discuss with you the kind of pump that will be most suitable for you and when you need to have your pump refilled. 
Vaš zdravnik se bo z vami pogovoril o tem, katera črpalka bo za vas najbolj primerna in kdaj jo boste morali ponovno napolniti.
The frequency and severity of adverse reactions were also lower. 
Nižji sta bili tudi pogostost in resnost neželenih učinkov.
SD - Standard Deviation. 
SD - standardna deviacija
• Suicidal thoughts or suicide attempt (may affect up to 1 in 100 people). 
• Samomorilne misli ali poskus samomora (lahko se pojavi pri največ 1 bolniku od 100 bolnikov).
The patient and health-care providers must be familiar with the handling of the external or internal infusion system and be aware of the need to guard against infection. 
Bolnik in zdravstveno osebje morajo biti vešči ravnanja z zunanjim ali implantiranim infuzijskim sistemom in se zavedati potrebe po varovanju pred infekcijo.
The minimal interval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more. 
Najmanjši interval med posameznim zvišanjem odmerka je 24 ur; zaradi večje varnosti uporabe znaša priporočeni interval 48 ur ali več.
The recommended starting dose is no more than 2.4 micrograms per day. 
Priporočeni začetni odmerek ne presega 2,4 mikrograma na dan.
The efficacy of IT ziconotide was apparent in all groups. 
Učinkovitost intratekalno apliciranega zikonotida je bila opazna v vseh skupinah.
17493 Greifswald-Insel Riems Germany 
17493 Greifswald-Insel Riems Nemčija
The biological activity of the various expected proteolytic degradation products has not been assessed. 
Biološka aktivnost različnih pričakovanih proteolitičnih razgradnih produktov zikonotida ni bila raziskana.
Efficacy results from study 301 
Rezultati učinkovitosti v študiji 301
These studies were of short duration, 5 and 6 days respectively, and used a more rapid dose escalation and higher doses than recommended in Section 4.2. 
Ti dve študiji sta bili kratkotrajni, trajali sta 5 oziroma 6 dni, v njih so bili uporabljeni višji odmerki in hitrejše zviševanje odmerkov, kot je priporočeno v poglavju 4.2.
Ziconotide does not interact with opiate receptors. 
Zikonotid se ne veže na opiatne receptorje.
Ziconotide did not induce bacterial gene mutation and was not genotoxic. 
Zikonotid ni induciral bakterijske genske mutacije in ni imel genotoksičnega učinka.
Children and adolescents Prialt is not recommended for use in children and adolescents. 
Otroci in mladostniki Uporaba zdravila Prialt pri otrocih in mladostnikih ni priporočljiva.
Some patients had more than one cause of pain. 
Nekateri bolniki so trpeli bolečine zaradi več vzrokov.
Intrathecal use. 
Intratekalna uporaba.
Efficacy results from study 95-001 
Rezultati učinkovitosti v študiji 95-001
Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume. 
Zikonotid moramo dajati kot neprekinjeno infuzijo po intratekalnem katetru in pri tem uporabljati zunanjo ali notranjo implantirano mehansko infuzijsko črpalko, ki lahko oddaja natančen infuzijski volumen.
Therefore, catheter tip placement should be carefully considered to allow adequate access to spinal nociceptive segments whilst minimising medicinal product concentrations at cerebral levels. 
Zaradi tega je potrebno skrbno izbrati mesto uvedbe katetra, da bi zdravilu omogočili ustrezen dostop do spinalnih nociceptivnih segmentov ob hkratni minimalni koncentraciji zdravila v možganskih predelih.
Cognitive impairment typically appears after several weeks of treatment. 
Kognitivne motnje se navadno pojavljajo po nekaj tednih zdravljenja.
Patients and physicians must be vigilant for typical symptoms and signs of meningitis. 
Bolniki in zdravniki morajo biti pozorni na tipične simptome in znake meningitisa.
The re-introduction of ziconotide is not recommended in these patients. 
Ponovna uvedba zikonotida pri teh bolnikh ni priporočljiva.
The cognitive effects of ziconotide are typically reversible within 1 - 4 weeks after discontinuation of the medicinal product, but may persist in some cases. 
Učinki zikonotida na kognitivne sposobnosti so značilno reverzibilni v 1 do 4 tednih po ukinitvi zdravila, v nekaterih primerih pa lahko vztrajajo.
Before giving you Prialt, your doctor might decide to slowly stop giving you opiates (other types of medicinal product which are used to treat pain) into your spinal cord and instead replace with alternative pain medicinal products. 
Preden boste dobili zdravilo Prialt, se bo vaš zdravnik morda odločil za postopno ukinitev dajanja opiatov (drugih vrst zdravil, ki se uporabljajo za zdravljenje bolečine) v vašo hrbtenjačo in jih nadomestil z drugimi zdravili proti bolečinam.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions. 
Če raztopina ni uporabljena takoj, je za čas hranjenja pripravljene raztopine in pogoje shranjevanja pred uporabo odgovoren uporabnik in čas shranjevanja raztopine običajno ne sme presegati 24 ur pri temperaturi 2 °C - 8 °C, razen, če je bila raztopina pripravljena pod nadzorovanimi in validiranimi aseptičnimi pogoji.
Although ziconotide has been studied in long-term, open label efficacy and safety clinical trials, controlled studies of longer than 3 weeks duration have not been conducted (see section 5.1). 
Čeprav so bile z zikonotidom opravljene dolgoročne odprte klinične študije učinkovitosti in varnosti, kontrolirane študije, ki bi bile daljše od 3 tednov, niso bile izvedene (glejte poglavje 5.1).
Bolus administration studies suggest that bolus dosing may be useful in identifying patients who may benefit from long term use of ziconotide, however, may result in more adverse reactions than administration by continuous infusion. 
Študije uporabe bolusov kažejo, da je odmerjanje v obliki bolusov lahko koristno za prepoznavanje bolnikov, ki jim dolgoročna uporaba zikonotida utegne koristiti, vendar pa ima lahko za posledico več neželenih učinkov kot dajanje z neprekinjeno infuzijo.
During a convulsion, the person's muscles contract and relax repeatedly and the person may lose consciousness. 
Med napadom se bolnikove mišice kar naprej krčijo in sproščajo in bolnik lahko izgubi zavest.
Within each frequency grouping undesirable effects are presented in order of decreasing frequency. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči pogostnosti.
You must tell your doctor immediately if you notice these serious side effects as you may require urgent medical treatment. 
Nemudoma povejte zdravniku, če opazite te resne neželene učinke, ker boste mogoče potrebovali nujno medicinsko zdravljenje.
Most patients under observation recovered within 24 hours of withdrawal of the medicinal product. 
Večina opazovanih bolnikov si je opomogla v 24 urah po ukinitvi zdravila.
The primary endpoint was the percent change in VASPI score. 
Osnovno merilo je predstavljala odstotna sprememba rezultata na VASPI skali.
If discontinuing opiates when initiating ziconotide therapy, opiate withdrawal should be gradual. 
Ob prenehanju uporabe opiatov ob uvedbi zdravljenja z zikonotidom je potrebno opiate ukinjati postopoma.
It is unknown whether ziconotide/metabolites are excreted in human milk. 
Ni znano, ali se zikonotid/presnovki izločajo v materino mleko.