natgillin/translations-raw huggingface dataset:
The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15. 
Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml]) je bil v skupini, ki je prejemala zdravilo ADROVANCE (70 mg/2.800 i.e.), v 15. tednu pomembno nižji (za 62,5 %) kot v skupini, ki je prejemala le alendronat (12 % oz. 32 %).
ADROVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other. 
ADROVANCE 70 mg/2.800 i.e. tablete imajo obliko modificirane kapsule, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘710'.
ADROVANCE 70 mg/5,600 IU tablets EU/1/06/364/006 - 2 tablets EU/1/06/364/007 - 4 tablets EU/1/06/364/008 - 12 tablets 
ADROVANCE 70 mg/5.600 i.e. tablete EU/1/06/364/006 - 2 tableti EU/1/06/364/007 - 4 tablete
Patients in the Vitamin D3 2,800 group received ADROVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received ADROVANCE (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed. 
Bolnice v skupini "Vitamin D3 2.800" so prejemale zdravilo ADROVANCE (70 mg/2.800 i.e.) (n = 299), bolnice v skupini "Vitamin D3 5.600" pa so prejemale zdravilo ADROVANCE (70 mg/2.800 i.e.) in dodatnih 2.800 i.e. vitamina D3 (n = 309) enkrat tedensko; dovoljeni so bili tudi drugi dodatki vitamina D. Po 24 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini "Vitamin D3 5.600" pomembno višje (69 nmol/l [27,6 ng/ml]) kot v skupini "Vitamin D3 2.800" (64 nmol/l [25,5 ng/ml]).
ADROVANCE 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other. 
ADROVANCE 70 mg/5.600 i.e. tablete imajo obliko modificiranega pravokotnika, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘270'.
Always take ADROVANCE exactly as your doctor or pharmacist has told you. 
Pri jemanju zdravila ADROVANCE natančno upoštevajte navodila zdravnika ali farmacevta.
These side effects may worsen if patients continue to take ADROVANCE after developing these symptoms. 
Če potem, ko so se že pojavili neželeni učinki, bolnik nadaljuje z jemanjem zdravila ADROVANCE, se lahko neželeni učinki še poslabšajo.
There is important additional information about how to take ADROVANCE in the package leaflet. 
V priloženem navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila ADROVANCE.
1) Choose the day of the week that best fits your schedule. 
1) Izberite dan v tednu, ki vam najbolj ustreza, nato pa vsak teden na izbrani dan vzemite eno tableto ADROVANCE.
ADROVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets. 
ADROVANCE 70 mg/2.800 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4, 6 ali 12 tablet.
ADROVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets. 
ADROVANCE 70 mg/5.600 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4 ali 12 tablet.
Each ADROVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3). 
Ena ADROVANCE 70 mg/2.800 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 70 mikrogramov (2.800 i.e.) holekalciferola (vitamina D3).
Each ADROVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3). 
Ena ADROVANCE 70 mg/5.600 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 140 mikrogramov (5.600 i.e.) holekalciferola (vitamina D3).
BLISTER FOR ADROVANCE 70 mg/2,800 IU 
ŠKATLA ZA ZDRAVILO ADROVANCE 70 mg/2.800 i.e.
ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol 
ADROVANCE 70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol 
ADROVANCE 70 mg/2.800 i.e. tablete alendronska kislina/holekalciferol
What ADROVANCE contains 
Kaj vsebuje zdravilo ADROVANCE
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE. 
Količina vitamina D v zdravilu ADROVANCE ne zadošča za odpravo pomanjkanja vitamina D. Pri bolnikih s temi boleznimi je treba med zdravljenjem z zdravilom ADROVANCE spremljati vrednost kalcija v serumu in simptome hipokalciemije.
BLISTER FOR ADROVANCE 70 mg/5,600 IU 
ŠKATLA ZA ZDRAVILO ADROVANCE 70 mg/5.600 i.e.
How to store ADROVANCE 
Shranjevanje zdravila ADROVANCE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR ADROVANCE 70 mg/2,800 IU 
PRETISNI OMOT ZA ZDRAVILO ADROVANCE 70 mg/2.800 i.e.
• Use of antibiotics 
• uporabo antibiotikov
The educational material contains the following: 
Izobraževalno gradivo vsebuje:
The physician information should contain the following key elements: 
Informacije za zdravnika morajo vsebovati naslednje ključne elemente:
ANNEX 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 V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented. 
Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani v nadaljevanju.
• When to seek urgent attention from their health care provider 
• v katerih primerih je treba poiskati nujno zdravstveno pomoč
• Aseptic techniques to minimise the risk of infection 
• aseptične tehnike za zmanjševanje tveganja okužbe
The Member States shall ensure that the provision of educational material implemented for the authorised indication of treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), is extended to the potential prescribers concerned by the new indication: treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis. 
Države članice morajo zagotoviti, da bodo izobraževalno gradivo, uporabljeno za odobrene indikacije zdravljenja pri odraslih bolnikih z makularnim edemom po okluziji veje retinalne vene (BRVOBranch Retinal Vein Occlusion) ali okluziji centralne retinalne vene (CRVO-Central Retinal Vein Occlusion), dobili vsi zdravniki, ki nameravajo predpisovati zdravilo z navedeno novo indikacijo: zdravljenje odraslih bolnikov z vnetjem posteriornega dela očesa, ki se kaže kot nenalezljivi uveitis.
• Key signs and symptoms of serious adverse events including increased intraocular pressure and ocular hypertension 
• ključne znake in simptome resnih neželenih dogodkov, vključno s povišanim očesnim tlakom in očesno hipertenzijo
• How to prepare for Ozurdex treatment 
• kako se pripraviti na zdravljenje z zdravilom Ozurdex
• Key signs and symptoms of IVT injection related adverse events including increased intraocular pressure, glaucoma, ocular hypertension, cataract, traumatic cataract related to injection technique, vitreous detachment, vitreous haemorrhage, endophthalmitis, 
• ključne znake in simptome neželenih dogodkov, povezanih z intravitrealnim injiciranjem, vključno s povišanim očesnim tlakom, glavkomom, očesno hipertenzijo, katarakto, poškodbeno katarakto v povezavi s tehniko injiciranja, odstopom steklovine, vitrealno krvavitvijo, endoftalmitisom, odstopom mrežnice, raztrganino mrežnice, mehansko okvaro pripomočka in vstavitvijo vsadka v nepravilen položaj
• What are the steps following treatment with Ozurdex 
• kaj sledi zdravljenju z zdravilom Ozurdex
The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch of the new indication in their territory. 
Države članice se morajo pred začetkom dajanja zdravila z novo indikacijo v promet na njihovem ozemlju dogovoriti z imetnikom dovoljenja za promet z zdravilom o vsebini končnega izobraževalnega gradiva.
• Management of IVT injection related adverse events The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements: 
Komplet informacij za bolnika je treba zagotoviti v obliki brošure in kot zvočno zgoščenko, ki vsebujeta naslednje ključne elemente:
• Patient information leaflet 
• komplet informacij za bolnika
• Patient monitoring after IVT injection 
• spremljanje bolnika po intravitrealnem injiciranju
• Techniques for the intravitreal injection 
• tehnike intravitrealnega injiciranja
The red area will fade over the next few days to a week. 
Rdečina bo izginila v naslednjih nekaj dneh ali tednu.
This may affect serum concentrations. 
To lahko vpliva na serumske koncentracije.
The Healthcare provider educational Programme shall contain the following key messages: 
Izobraževalni program za zdravstvene delavce mora vsebovati ta ključna sporočila:
The maximum treatment duration is 72 hours, although the majority of patients should only need one system. 
Najdaljše trajanje zdravljenja je 72 ur, čeprav bo večina bolnikov verjetno potrebovala samo en sistem.
Probable cause 
Verjetni vzrok
EXP Use immediately after opening. 
EXP Uporabite takoj po odprtju.
Currently available data are described in section 4.8, but no recommendation on posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavju 4.8, vendar priporočil o odmerjanju ni mogoče dati.
This is common, and nothing to worry about. 
To je pogost pojav in naj vas ne skrbi.
Do not let these touch your mouth or eyes. 
Ne pustite, da se gela dotakneta ust ali oči.
The table below represents the different error messages that may occur, together with the probable cause and the action to be taken. 
V spodnji preglednici so različna sporočila o napakah, ki se lahko pojavijo, skupaj z verjetnim vzrokom in potrebnim ukrepom.
The next dose cannot be initiated until the previous 10-minute delivery period is complete. 
Dovajanje naslednjega odmerka se ne more začeti, dokler prejšnje 10-minutno obdobje odmerjanja ni končano.
These were mostly of mild to moderate severity. 
Večinoma so blagi do zmerni.
• Each dose will last for 10 minutes. 
• Vsako odmerjanje traja 10 minut.
• abnormal dreams or hallucinations (seeing or hearing things that are not there) 
• nenormalne sanje ali halucinacije (videnje ali slišanje stvari, ki jih ni)
The mean systemic bioavailability is 87%. 
Povprečna sistemska biološka uporabnost je 87 %.
Adequate body temperature and fluid intake should also be maintained. 
Poleg tega je treba ohranjati ustrezno telesno temperaturo in vnos tekočin.
Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344 Email: medical.information@themedco.com 
Tel.: +44 (0)800 587 4149 ali +44 (0)203 684 6344 E-pošta: medical.information@themedco.com
• If you do accidentally touch the gels on the underside of the system: 
• Če se pomotoma dotaknete gelov na spodnji strani sistema:
p-value C-2001-011 27 % (64/235) 57 % (116/204) <0.0001 
vrednost p C-2001-011 27 % (64/235) 57 % (116/204) 0,0001
Information for the Healthcare Professional: Instructions for use and disposal 
Informacije za zdravstveno osebje: Navodila za uporabo in odstranjevanje
The used system should be handled carefully by the sides and top. 
Uporabljen sistem je treba previdno prijeti ob straneh in zgoraj.
Take care not to touch the hydrogels. 
Pazite, da se ne dotaknete hidrogelov.
Patients should not wear more than one system at a time. 
Bolniki ne smejo nositi več kot enega sistema naenkrat.
Efficacy results at the end of 24 hours, are presented in Table 2 below for the evaluable patient population. 
Rezultati učinkovitosti na koncu 24 ur so predstavljeni v preglednici 2 spodaj za ocenljivo populacijo bolnikov.
Do not use the system. 
Sistema ne uporabljajte.
This tray contains: 1 Drug Unit, 1 Controller. 
Podstavek vsebuje: 1 zdravilno enoto, 1 upravljalnik.
Patients were instructed to use the system for pain relief. 
Bolnike so poučili o uporabi sistema za lajšanje bolečin.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1050/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1050/001
• blue skin colour (lips and finger tips) 
• modra obarvanost kože (ustnice in konice prstov)
• Educational material (including prescriber checklist) for the healthcare professionals 
• izobraževalno gradivo (vključno s kontrolnim seznamom za predpisovalce) za zdravstvene delavce.
After this point 727 patients remained in the studies using only the IONSYS or control system, and were evaluated for efficacy. 
Potem je 727 bolnikov ostalo v študijah, kjer so uporabljali samo sistem IONSYS ali kontrolni sistem in bili ocenjeni glede na učinkovitost.
Its primary therapeutic actions are analgesia and sedation. 
Primarna terapevtska učinka sta analgezija in sedacija.
Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). 
Opioidni analgetiki poslabšajo psihično in/ali telesno sposobnost, potrebno za opravljanje potencialno nevarnih nalog (npr. vožnje avtomobila ali upravljanja strojev).
Action required 
Potrebni ukrep
After 24 hours or 80 doses, a new system should be applied if necessary. 
Po 24 urah ali 80 odmerkih se po potrebi uporabi nov sistem.
A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations. 
Tveganje mutagenih učinkov se zdi pri uporabi terapevtskih odmerkov malo verjetno, saj so se učinki pojavili samo pri visokih koncentracijah.
Special precautions for disposal should be followed (see section 6.6). 
Upoštevati je treba posebne previdnostne ukrepe za odstranjevanje (glejte poglavje 6.6).
Head injuries and increased intracranial pressure 
Poškodbe glave in zvišan intrakranialni tlak
Each patient and investigator was asked to rate the patient's method of pain control as either poor, fair, good, or excellent. 
Vsak bolnik in raziskovalec je ocenil bolnikovo metodo obvladovanja bolečine kot slabo, zadostno, dobro ali odlično.
Oxygen should be administered and respiration assisted or controlled, as appropriate. 
Treba je dajati kisik in podpirati ali nadzorovati dihanje, kakor je primerno.
Remove system from patient. 
Odstranite sistem z bolnika.
Prolonged contact with water could affect system performance and cause the system to fall off. 
Daljši stik z vodo bi lahko vplival na delovanje sistema in povzročil, da bi se sistem odlepil s kože.
Swallowing or touching these gels may cause life-threatening breathing difficulties or death, even after you have stopped using the system and it has been removed. 
Zaužitje ali dotik teh gelov lahko povzroči smrtno nevarne težave z dihanjem ali smrt, tudi potem ko sistem prenehate uporabljati in je že odstranjen.
IONSYS will then shut down and will not deliver any further doses. 
IONSYS se bo nato izklopil in ne bo dovedel nadaljnjih odmerkov.
80 doses 
80 odmerkih
You can take a dose whenever you need it for your pain, or just before you do an activity that may increase your pain (such as physical therapy, getting out of bed, etc.). 
Odmerek lahko vzamete, kadar ga potrebujete zaradi bolečin, ali tik pred dejavnostmi, ki bi lahko povečale bolečine (npr. fizioterapijo, vstajanjem iz postelje).
Abuse or intentional misuse of IONSYS may result in overdose and/or death. 
Zloraba ali namerna napačna uporaba zdravila IONSYS lahko povzroči preveliko odmerjanje in/ali smrt.
Remove the sachet and the controller. 
Odstranite vrečko in upravljalnik.
In this situation, special patient care and observation are appropriate. 
V teh okoliščinah sta potrebna posebna oskrba in opazovanje bolnika.
Remember that only the patient may touch the dosing button. 
Ne pozabite, da se sme samo bolnik dotakniti gumba za odmerjanje.
Contact with the hydrogel should be avoided. 
Treba je preprečiti stik s hidrogelom.
All adverse reactions are listed by System Organ Class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); and rare (≥1/10,000 
Vsi neželeni učinki so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in redki (≥ 1/10.000 do < 1/1.000).
The design of the system allows separate disposal of the hydrogel housing and the Controller. 
Zasnova sistema omogoča ločeno odlaganje hidrogelnega ohišja in upravljalnika.
You control your own treatment under the guidance of your doctor or nurse in hospital. 
Zdravljenje nadzorujete sami pod vodstvom zdravnika ali medicinske sestre v bolnišnici.
Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant. 
Zdravnik se bo z vami pogovoril o morebitnih tveganjih in koristih uporabe zdravila IONSYS med nosečnostjo.
An alternative application site should be chosen. 
Izbrati je treba drugo mesto aplikacije.
Tell your doctor or nurse if: 
Zdravniku ali medicinski sestri morate povedati, če:
IONSYS is not recommended for children and adolescents under 18 years of age due to the lack of data in these patients. 
Zdravilo IONSYS se ne priporoča otrokom in mladostnikom, mlajšim od 18 let, zaradi pomanjkanja podatkov pri teh bolnikih.
Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment. 
Bolniki z anamnezo odvisnosti od drog ali zlorabe alkohola so v večji nevarnosti za razvoj odvisnosti in zlorabo pri zdravljenju z opioidi.
Reversal of the narcotic effect may also result in acute onset of pain and release of catecholamines. 
Odprava narkotičnega učinka lahko pripelje tudi do akutnega pojava bolečine in sproščanja kateholaminov.
Thus, the adverse reaction profile does not suggest a meaningful difference in safety compared to patients younger than 65 years of age. 
Profil neželenih učinkov torej ne kaže pomembnih razlik v varnosti v primerjavi z bolniki, mlajšimi od 65 let.
years. 
2 leti
As illustrated in Table 1 below, IONSYS (fentanyl hydrochloride) was superior to placebo in all studies. 
Kot je prikazano v preglednici 1 spodaj, je bilo zdravilo IONSYS (fentanilov hidroklorid) boljše od placeba v vseh študijah.
• Choose healthy, unbroken skin (non-irritated and nonirradiated skin) site on the chest or upper outer arm ONLY. 
• Izberite zdravo, nepoškodovano kožo (nerazdraženo in neobsevano) SAMO na prsih ali zunanjem delu nadlahti.
Fentanyl pharmacokinetics are similar with both single and multiple 24 hour applications. 
Farmakokinetika fentanila je podobna pri posamezni in večkratni 24-urni aplikaciji.
This side of the system contains material called “gels” which you should not normally come into contact with. 
Ta stran sistema vsebuje dva gela, ki se ju navadno ne smete dotikati.
For management of respiratory depression, immediate countermeasures include removing the IONSYS system and physically or verbally stimulating the patient. 
Med takojšnjimi protiukrepi za obvladovanje depresije dihanja so odstranitev sistema IONSYS in telesna ali verbalna stimulacija bolnika.
The plasma protein binding of fentanyl is 80% to 85%. 
Vezava fentanila na plazemske beljakovine je od 80- do 85-odstotna.
Therefore, the use of any of these medicinal products concomitantly with IONSYS requires special patient care and observation. 
Zato sta pri uporabi katerega koli od teh zdravil sočasno s sistemom IONSYS potrebna posebna oskrba in opazovanje bolnika.
Physicians should evaluate patients for a history of drug abuse and follow such patients closely. 
Zdravnik mora oceniti bolnikovo zgodovino zlorabe zdravil in drog ter takšne bolnike pozorno spremljati.
Long-lasting or any non-opioid analgesics were not permitted. 
Uporaba dolgodelujočega ali katerega koli neopioidnega analgetika ni bila dovoljena.
Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance. 
Bolnikom je treba svetovati, naj ne vozijo ali upravljajo strojev, če so zaspani, omotični ali imajo motnje vida.
• Do not let your family or friends start IONSYS for you. 
• Ne dovolite, da družinski člani ali prijatelji aktivirajo vaš sistem IONSYS.
• severe headache (migraine) 
• hud glavobol (migrena)
Pharmacotherapeutic group: Analgesics; phenylpiperidine derivatives; ATC code: N02AB03. 
Farmakoterapevtska skupina: analgetiki; derivati fenilpiperidina; oznaka ATC: N02AB03.
• IONSYS is ready to be used again and you may start another dose at any time you need it. 
• Sistem IONSYS je takrat pripravljen za ponovno uporabo in sprožite lahko nov odmerek, kadar koli ga boste potrebovali.
The half-life of the antagonist may be short; therefore, repeated administration or infusion of the antagonist may be necessary. 
Razpolovni čas antagonista je lahko kratek, zato bosta morda potrebna večkratno dajanje ali infuzija antagonista.
• low calcium/glucose/potassium in blood serum 
• nizka raven kalcija/glukoze/kalija v krvnem serumu
A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential. 
V študiji kancerogenosti (dnevne podkožne injekcije fentanilovega hidroklorida v obdobju dveh let pri podganah Sprague Dawley) ni bilo ugotovitev, ki bi kazale na onkogeni potencial.
Administration during childbirth is not recommended because fentanyl crosses the placenta and the fetal respiratory centre is sensitive to opiates. 
Uporaba med porodom se ne priporoča, ker fentanil prehaja skozi posteljico in je dihalni center ploda občutljiv za opiate.
The safety of IONSYS has not been established in patients with American Society of Anesthesiologists (ASA) physical status classification IV (i.e. patients with a severe systemic disease that is a constant threat to life). 
Varnost zdravila IONSYS ni dokazana pri bolnikih z zdravstvenim stanjem IV na lestvici ASA (American Society of Anesthesiologists), tj. bolnikih s hudo sistemsko boleznijo, ki pomeni stalno smrtno nevarnost.
• you have a very slow heart rate, low blood pressure, or other serious heart problem 
• če imate zelo počasen srčni utrip, nizek krvni tlak ali drugo resno težavo s srcem;
Fentanyl can be abused in a manner similar to other opioid agonists. 
Fentanil se lahko zlorabi podobno kot drugi opioidni agonisti.
If you are an older patient your doctor will monitor you more carefully as IONSYS may affect you more than a younger patient. 
Če ste starejši, vas bo zdravnik natančneje spremljal, saj ima lahko zdravilo IONSYS pri vas večji učinek kot pri mlajših bolnikih.
• Information highlighting that IONSYS is a patient-controlled device to be used in a hospital setting only and that standard practices for monitoring patients using such devices should be followed by healthcare professionals. 
• Informacije, ki poudarjajo, da je Ionsys pripomoček, ki ga nadzoruje bolnik in se uporablja samo v bolnišnicah ter da morajo zdravstveni delavci upoštevati standardne prakse spremljanja bolnikov, ki uporabljajo take pripomočke.
With intravenous administration, the initial distribution half-life is approximately 6 minutes; the second distribution half-life is 1 hour, and the terminal half-life is 13 hours. 
Pri intravenski uporabi je začetni razpolovni čas porazdelitve približno 6 minut, drugi razpolovni čas je 1 ura in končni 13 ur.
The European Medicines Agency has deferred the obligation to submit the results of studies with IONSYS in one or more subsets of the paediatric population for the treatment of acute pain. 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom IONSYS za eno ali več podskupin pediatrične populacije, zdravljenih zaradi akutne bolečine.