natgillin/translations-raw huggingface dataset:
ADROVANCE 70 mg/2,800 IU tablets EU/1/06/364/001 - 2 tablets 
ADROVANCE 70 mg/2800 IU tablete EU/1/06/364/001 - 2 tablete
Every week, take one ADROVANCE tablet on your chosen day. 
Svakoga tjedna, u odabrani dan, uzmite jednu ADROVANCE tabletu.
It is likely that certain medicines or food additives may prevent the vitamin D in ADROVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol. 
Moguće je da neki lijekovi ili dodaci prehrani, uključujući umjetne zamjenske masti, mineralna ulja, lijekove za smanjenje tjelesne težine, orlistat te lijekove za snižavanje kolesterola kolestiramin i kolestipol, mogu spriječiti da vitamin D koji je sadržan u lijeku ADROVANCE uđe u Vaše tijelo.
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. 
Bolesnice u skupini Vitamin D3 2800 uzimale su ADROVANCE (70 mg/2800 IU) (n=299) jedanput na tjedan, dok su bolesnice u skupini Vitamin D3 5600 uzimale ADROVANCE (70 mg/2800 IU) uz dodatak 2800 IU vitamina D3 (n=309) jedanput na tjedan; bio je dopušten dodatni nadomjestak vitamina D.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE. 
U bolesnica s ovim stanjima se tijekom liječenja lijekom ADROVANCE moraju pratiti koncentracija kalcija u serumu i simptomi hipokalcijemije.
The bioavailability of the 2,800 IU vitamin D3 in ADROVANCE is similar to 2,800 IU vitamin D3 administered alone. 
Bioraspoloživost 2800 IU vitamina D3 u lijeku ADROVANCE slična je onoj kod primjene 2800 IU samog vitamina D3.
In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the ADROVANCE (70 mg/2,800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70). 
U ovom su ispitivanju srednje vrijednosti 25-hidroksivitamina D u bolesnica s početnim nedostatkom vitamina D (25-hidroksivitamin D, 22,5 do 37,5 nmol/l [9 do < 15 ng/ml]) liječenih ADROVANCE tabletama (70 mg/2800 IU) (n=75) porasle s početnih 30 nmol/l (12,1 ng/ml) na 40 nmol/l (15,9 ng/ml) u 15. tjednu, dok su u skupini koja je primala samo alendronat one u 15. tjednu pale s početnih 30 nmol/l (12,0 ng/ml) na 26 nmol/l (10,4 ng/ml) (n=70).
The alendronate component in the ADROVANCE (70 mg/2,800 IU) combination tablet and the ADROVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet. 
Alendronat sadržan u kombiniranoj ADROVANCE (70 mg/2800 IU) tableti i kombiniranoj ADROVANCE (70 mg/5600 IU) tableti bioekvivalentan je alendronatu u tableti od 70 mg.
Patients received the lower strength (70 mg/2,800 IU) of ADROVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited. 
Bolesnice su jedanput na tjedan primale ADROVANCE u nižoj dozi (70 mg/2800 IU) (n=350) ili FOSAMAX (alendronat) u dozi od 70 mg (n=332); dodatni nadomjestak vitamina
BLISTER FOR ADROVANCE 70 mg/5,600 IU 
BLISTER ZA ADROVANCE 70 mg/5600 IU
BLISTER FOR ADROVANCE 70 mg/2,800 IU 
BLISTER ZA ADROVANCE 70 mg/2800 IU
ADROVANCE 70 mg/5,600 IU tablets 
ADROVANCE 70 mg/5600 IU tablete
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/5600 IU tablete EU/1/06/364/006 - 2 tablete EU/1/06/364/007 - 4 tablete EU/1/06/364/008 - 12 tableta
EU/1/06/364/001 (2 tablets) EU/1/06/364/002 (4 tablets) EU/1/06/364/003 (6 tablets) EU/1/06/364/004 (12 tablets) 
EU/1/06/364/001 (2 tablete) EU/1/06/364/002 (4 tablete) EU/1/06/364/003 (6 tableta) EU/1/06/364/004 (12 tableta)
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/5600 IU tablete su bijele do gotovo bijele tablete oblika preinačenog pravokutnika s oznakom kosti na jednoj strani i utisnutom oznakom '270' na drugoj.
The equivalence of intake of 5,600 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 800 IU has not been studied. 
Nije ispitano odgovara li tjedna doza vitamina D3 od 5600 IU u lijeku ADROVANCE dnevnom doziranju vitamina D od 800 IU.
The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively). 
Postotak ispitanica s manjkom vitamina D (25-hidroksivitamin D < 22,5 nmol/l [< 9 ng/ml] u serumu) značajno je smanjen za 92% u skupini koja je primala ADROVANCE (70 mg/2800 IU) naspram skupine koja je primala samo alendronat (1% naspram 13%).
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking ADROVANCE and contact your doctor. 
5) Prestanite uzimati ADROVANCE i obratite se svom liječniku ako osjetite teškoće ili bol pri gutanju, bol u prsištu, žgaravicu ili pogoršanje žgaravice.
ADROVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets. 
ADROVANCE 70 mg/5600 IU tablete dostupne su u pakiranjima koja sadrže 2, 4 ili 12 tableta.
ADROVANCE 70 mg/2,800 IU tablets ADROVANCE 70 mg/5,600 IU tablets 
ADROVANCE 70 mg/2800 IU tablete ADROVANCE 70 mg/5600 IU tablete
EU/1/06/364/003 - 6 tablets 
EU/1/06/364/003 - 6 tableta
ADROVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. 
Zbog nedostatka iskustva ADROVANCE se ne preporučuje bolesnicama s oštećenjem funkcije bubrega u kojih je klirens kreatinina manji od 35 ml/min.
EU/1/06/364/006 (2 tablets) EU/1/06/364/007 (4 tablets) EU/1/06/364/008 (12 tablets) 
EU/1/06/364/006 (2 tablete) EU/1/06/364/007 (4 tablete) EU/1/06/364/008 (12 tableta)
ADROVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets. 
ADROVANCE 70 mg/5600 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4 ili 12 tableta.
The equivalence of intake of 2,800 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 400 IU has not been studied. 
Nije ispitano odgovara li tjedna doza vitamina D3 od 2800 IU u lijeku ADROVANCE dnevnom doziranju vitamina D od 400 IU.
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/2800 IU tablete su bijele do gotovo bijele tablete oblika preinačene kapsule s oznakom kosti na jednoj strani i utisnutom oznakom '710' na drugoj.
ADROVANCE 70 mg/2,800 IU tablets 
ADROVANCE 70 mg/2800 IU tablete
EU/1/06/364/004 - 12 tablets 
EU/1/06/364/004 - 12 tableta
ADROVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets. 
ADROVANCE 70 mg/2800 IU tablete Aluminij/aluminij blisteri u kutijama sa 2, 4, 6 ili 12 tableta.
EU/1/06/364/002 - 4 tablets 
EU/1/06/364/002 - 4 tablete
ADROVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets. 
ADROVANCE 70 mg/2800 IU tablete dostupne su u pakiranjima koja sadrže 2, 4, 6 ili 12 tableta.
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. 
Apsorpciju vitamina D mogu smanjiti olestra, mineralna ulja, orlistat i ionski izmjenjivači (npr. kolestiramin i kolestipol).
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. 
Do 15. tjedna postotak bolesnica s nedostatkom vitamina D (25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml] u serumu) u skupini koja je primala ADROVANCE (70 mg/2800 IU) značajno je smanjen za 62,5%, naspram skupine koja je primala samo alendronat (12% naspram 32%).
In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml. 
Prosječna površina ispod krivulje koncentracija u serumu: vrijeme (AUC0-80 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene ADROVANCE 70 mg/5600 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 490,2 ng•hr/ml.
In healthy adult subjects (males and females), following administration of ADROVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml. 
Prosječna površina ispod krivulje koncentracija u serumu: vrijeme (AUC0-120 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene ADROVANCE 70 mg/2800 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 296,4 ng•hr/ml.
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). 
Jedna ADROVANCE 70 mg/5600 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 140 mikrograma (5600 IU) kolekalciferola (vitamina D3).
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the ADROVANCE (70 mg/2,800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]). 
D u serumu bile su značajno više (26%) u skupini koja je primala ADROVANCE (70 mg/2800 IU) (56 nmol/l [23 ng/ml]) u odnosu na skupinu koja je primala samo alendronat (46 nmol/l [18,2 ng/ml]).
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). 
Jedna ADROVANCE 70 mg/2800 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 70 mikrograma (2800 IU) kolekalciferola (vitamina D3).
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis. 
Katabolizam vitamina D mogu povećati antikonvulzivi, cimetidin i tiazidi.
The effect of the lower dose of ADROVANCE (alendronate 70 mg/vitamin D3 2,800 IU) plus an additional 2,800 IU Vitamin D3 for a total of 5,600 IU (the amount of vitamin D3 in the higher dose of ADROVANCE) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women. 
U 24-tjednom nastavku ispitivanja koje je uključilo 619 žena u postmenopauzi s osteoporozom dokazan je učinak niže doze lijeka ADROVANCE (alendronat 70 mg/vitamin D3 2800 IU) uz dodatak 2800 IU vitamina D3, što čini ukupno 5600 IU (količina vitamina D3 u višoj dozi lijeka ADROVANCE) jedanput na tjedan.
The mean maximal serum concentration (Cmax) of vitamin D3 was 5.9 ng/ml, and the median time to maximal serum concentration (Tmax) was 12 hours. 
Prosječna najviša koncentracija (Cmax) vitamina D3 u serumu iznosila je 5,9 ng/ml,
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of ADROVANCE if taken at the same time. 
Uzmete li ADROVANCE istodobno s nadomjescima kalcija, antacidima i nekim lijekovima koji se uzimaju kroz usta, oni će vjerojatno utjecati na njegovu apsorpciju.
ADROVANCE 70 mg/2,800 IU tablets alendronic acid /colecalciferol 
ADROVANCE 70 mg/2800 IU tablete alendronatna kiselina/kolekalciferol
ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol 
ADROVANCE 70 mg/5600 IU tablete alendronatna kiselina/kolekalciferol
Excipients 
ADROVANCE
ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol 
70 mg/2800 IU tablete alendronatna kiselina/kolekalciferol
ADROVANCE studies 
Prijavljivanje nuspojava
This is common, and nothing to worry about. 
To je uobičajeno, ne treba brinuti oko toga.
The red area will fade over the next few days to a week. 
Crveno područje izblijedit će nakon nekoliko dana do tjedan dana.
- Do not take it off or attempt to put it back on yourself. 
- Nemojte ga skidati ili pokušavati vraćati sami.
Do not let these touch your mouth or eyes. 
Nemojte dopustiti da dođu u dodir s ustima ili očima.
80 doses 
80 doza
You must talk to a doctor if you do not feel better or if you feel worse. 
Obratite se liječniku ako se ne osjećate bolje ili ako se osjećate lošije.
IONSYS with food, drink and alcohol 
IONSYS s hranom, pićem i alkoholom
The Healthcare provider educational Programme shall contain the following key messages: 
Obrazovni program za pružatelje zdravstvene zaštite će uključivati sljedeće ključne poruke:
Do not use the system. 
Nemojte koristiti sustav.
The maximum treatment duration is 72 hours, although the majority of patients should only need one system. 
Najduže trajanje liječenja je 72 sata, iako će većini bolesnika trebati samo jedan sustav.
Currently available data are described in section 4.8, but no recommendation on posology can be made. 
Trenutno dostupni podaci opisani su u dijelu 4.8, međutim nije moguće dati preporuku o doziranju.
• blue skin colour (lips and finger tips) 
• plava boja kože (usne i jagodice prstiju)
The next dose cannot be initiated until the previous 10-minute delivery period is complete. 
Sljedeća doza se ne može započeti primjenjivati dok nije dovršeno prethodno 10-minutno razdoblje isporuke.
• Each dose will last for 10 minutes. 
• Jedna doza trajat će 10 minuta.
This may affect serum concentrations. 
To može utjecati na koncentracije u serumu.
Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344 Email: medical.information@themedco.com 
Tel: +44 (0)800 587 4149 ili +44 (0)203 684 6344 E-mail: medical.information@themedco.com
• Educational material (including prescriber checklist) for the healthcare professionals 
• Edukacijski materijali (uključujući kontrolni popis za propisivanje lijeka) za zdravstvene radnike
There was no indication of teratogenic effects in studies in two species (rats and rabbits). 
Nije bilo indikacije teratogenih učinka u ispitivanjima u dvije vrste (štakori i kunići).
This side of the system contains material called “gels” which you should not normally come into contact with. 
Ova strana sustava sadrži materijal koji se zove „gelovi“ i s kojima obično ne biste smjeli doći u dodir.
Take care not to touch the hydrogels. 
Pazite da ne dodirujete hidrogelove.
Physical status 
Fizikalni status
Concomitant use of analgesics was not allowed after 3 hours in Studies C-2000-007 and CAPSS-320. 
Istodobna primjena analgetika nije bila dopuštena nakon 3 sata u ispitivanjima C-2000-007 i CAPSS-320.
Its primary therapeutic actions are analgesia and sedation. 
Njegovo primarno terapijsko djelovanje je analgezija i sedacija.
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.). 
Možete uzeti dozu kad god Vam treba za bol, ili neposredno prije aktivnosti koja bi mogla povećati bol (kao što je fizikalna terapija, izlazak iz kreveta itd.).
Important things to be aware of 
Važne stvari o kojima treba voditi računa
Head injuries and increased intracranial pressure 
Ozljede glave i povećani intrakranijalni tlak
Abuse potential and dependence 
Mogućnost zlouporabe i ovisnosti
- Do not let the IONSYS system get wet because it could stop working or fall off. 
- Nemojte dopustiti da se sustav IONSYS smoči jer bi mogao prestati raditi ili otpasti.
If you are an older patient your doctor will monitor you more carefully as IONSYS may affect you more than a younger patient. 
Ako ste stariji bolesnik, Vaš liječnik će Vas pozornije nadgledati, budući da IONSYS na Vas može utjecati više nego na nekog mlađeg bolesnika.
Remove system from patient. 
Uklonite sustav s bolesnika.
• Blinking red light for 15 seconds 
• Crveno svjetlo treperi 15 sekundi
Patients were instructed to use the system for pain relief. 
Bolesnici su upućeni da koriste sustav za ublažavanje boli.
You control your own treatment under the guidance of your doctor or nurse in hospital. 
Kontrolirate vlastito liječenje pod vodstvom svojeg liječnika ili medicinske sestre u bolnici.
Low battery or defective system 
Slaba baterija ili neispravan sustav
Prolonged contact with water could affect system performance and cause the system to fall off. 
Produženi kontakt s vodom može utjecati na rad sustava i prouzročiti otpadanje sustava.
The mean systemic bioavailability is 87%. 
Srednja vrijednost sistemske bioraspoloživosti je 87%.
• IONSYS is ready to be used again and you may start another dose at any time you need it. 
• IONSYS je spreman za ponovno korištenje i možete započeti drugu dozu kad god Vam je potrebna.
• Do not touch the sticky side of IONSYS. 
• Ne dodirujte ljepljivu stranu sustava IONSYS.
Probable cause 
Mogući uzrok
IONSYS only delivers the medicine when you activate it, so you control how much medicine you receive. 
IONSYS samo isporučuje lijek kada ga aktivirate, tako da kontrolirate koliko lijeka dobivate.
A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations. 
Mutageni rizik kod primjene terapijskih doza ne izgleda vjerojatan jer su se učinci pojavili samo pri visokim koncentracijama.
The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established. 
Sigurnost i djelotvornost sustava IONSYS u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
Adequate body temperature and fluid intake should also be maintained. 
Potrebno je također održati prikladnu temperaturu tijela i unos tekućina.
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. 
S intravenskom primjenom, početni poluvijek distribucije približno je 6 minuta; drugi poluvijek distribucije je 1 sat, a terminalni poluvijek je 13 sati.
The design of the system allows separate disposal of the hydrogel housing and the Controller. 
Dizajn sustava omogućuje odvojeno zbrinjavanje kućišta hidrogela i kontrolera.
Check with your doctor or nurse if you are not sure about how to use IONSYS or forget your instructions. 
Provjerite sa svojim liječnikom ili medicinskom sestrom ako niste sigurni kako koristiti IONSYS ili ste zaboravili upute.
The table below represents the different error messages that may occur, together with the probable cause and the action to be taken. 
Tablica u nastavku prikazuje razne poruke o pogrešci koje se mogu pojaviti, zajedno s mogućim uzrokom i potrebnom radnjom.
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 analgetici mogu smanjiti mentalne i/ili fizičke sposobnosti koje su potrebne za izvršavanje potencijalno opasnih zadataka (npr. upravljanje vozilima ili rad sa strojevima).
Information for the Healthcare Professional: Instructions for use and disposal 
Informacije za zdravstvenog radnika: Upute za primjenu i zbrinjavanje
Thus, the adverse reaction profile does not suggest a meaningful difference in safety compared to patients younger than 65 years of age. 
Zbog toga profil nuspojava ne upućuje na značajnu razliku u sigurnosti u usporedbi s bolesnicima mlađim od 65 godina starosti.
Remember that only the patient may touch the dosing button. 
Upamtite da samo bolesnik smije koristiti dugme za doziranje.
These were mostly of mild to moderate severity. 
Većina slučajeva bila je blage do umjerene težine.
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. 
Gutanje ili dodirivanje tih gelova može prouzročiti poteškoće disanja opasne po život ili smrt, čak i nakon što ste prestali koristiti sustav i nakon što je uklonjen.
IONSYS will then shut down and will not deliver any further doses. 
IONSYS će se zatim isključiti i neće više isporučivati doze.
Your doctor or nurse will remove the IONSYS system before you leave hospital. 
Vaš liječnik ili medicinska sestra uklonit će sustav IONSYS prije nego odete iz bolnice.
IV-PCA (morphine) n=1298 
IV-PCA (morfin) n = 1298
The half-life of the antagonist may be short; therefore, repeated administration or infusion of the antagonist may be necessary. 
Poluvijek antagonista može biti kratak, stoga može biti potrebna ponovljena primjena ili infuzija antagonista.
Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo. 
Utjecaji na embrio bili su posljedica toksičnosti za majku, a ne izravni učinci tvari na embrio u razvoju.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1050/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1050/001
After 24 hours or 80 doses, a new system should be applied if necessary. 
Nakon 24 sata ili 80 doza mora se primijeniti novi sustav, ako je potrebno.
Excessive sweating may reduce delivery of fentanyl. 
Prekomjerno znojenje može smanjiti isporuku fentanila.
You must tell your doctor before using IONSYS if you are pregnant or planning to become pregnant. 
Morate obavijestiti liječnika prije nego koristite sustav IONSYS ako ste trudni ili planirate trudnoću.
Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant. 
Vaš liječnik će raspraviti moguće rizike i potencijalne koristi primjene sustava IONSYS dok ste trudni.
• anaemia (low blood count) 
• anemija (nizak broj krvnih stanica)
However, once a system has been removed, the same system should not be reapplied. 
No kad se jednom sustav ukloni, taj isti sustav ne smije se ponovno primijeniti.
In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight. 
ispitivanju prenatalnog i postnatalnog razvoja, stopa preživljenja mladunaca znatno se smanjila pri dozama koje su malo smanjile majčinu težinu.
Tell your doctor or nurse if: 
Obavijestite svog liječnika ili medicinsku sestru ako:
Each patient and investigator was asked to rate the patient's method of pain control as either poor, fair, good, or excellent. 
Svaki bolesnik i ispitivač trebao je ocijeniti metodu kontrole boli bolesnika kao lošu, osrednju, dobru ili odličnu.
IONSYS is not recommended for children and adolescents under 18 years of age due to the lack of data in these patients. 
IONSYS se ne preporučuje u djece i adolescenata mlađih od 18 godina starosti zbog nedostatka podataka u tih bolesnika.
To make sure you get the correct amount of medicine, press IONSYS as soon as you start to feel pain. 
Kako biste bili sigurni da dobivate ispravnu količinu lijeka, pritisnite IONSYS čim počnete osjećati bol.
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 
Sve su nuspojave razvrstane prema klasifikaciji organskih sustava i učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100) i rijetko
Pharmacotherapeutic group: Analgesics; phenylpiperidine derivatives; ATC code: N02AB03. 
Farmakoterapijska skupina: Analgetici; derivati fenilpiperidina; ATK oznaka: N02AB03.
p-value C-2001-011 27 % (64/235) 57 % (116/204) <0.0001 
pvrijednost C-2001-011 27 % (64/235) 57 % (116/204) <0,0001 C-2000-008 25 % (36/142) C-95-016