natgillin/translations-raw huggingface dataset:
Patients were randomised to either placebo, eptifibatide 180 microgram/kg bolus followed by a 2.0 microgram/kg/min infusion (180/2.0), or eptifibatide 180 microgram/kg bolus followed by a 1.3 microgram/kg/min infusion (180/1.3). 
Bolesnici su randomizirani ili u skupinu koja je primala placebo ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 2,0 mikrograma/kg/min (180/2,0), ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 1,3 mikrograma/kg/min (180/1,3).
If you have any questions, ask your doctor or hospital pharmacist or nurse. 
Ako imate nekih pitanja, pitajte svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
− reduction in the number of platelets (blood cells necessary for blood clotting). 
− smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).
Eptifibatide Accord 2 mg/ml solution for injection: 10 ml vial, pack of one vial. 
Eptifibatid Accord 2 mg/ml otopina za injekciju: bočica s 10 ml, kutija s jednom bočicom.
If the platelet count falls below 100,000/mm3, further platelet counts are required to rule out pseudothrombocytopenia. 
100 000/mm3, treba ponoviti test broja trombocita kako bi se isključila pseudotrombocitopenija.
However, in a population pharmacokinetic study there was no evidence of a pharmacokinetic interaction between eptifibatide and the following concomitant medicinal products: amlodipine, atenolol, atropine, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin. 
cefazolin, diazepam, digoksin, diltiazem, difenhidramin, enalapril, fentanil, furosemid, heparin, lidokain, lizinopril, metoprolol, midazolam, morfin, nitrati, nifedipin i varfarin.
In patients with moderate renal impairment (creatinine clearance ≥ 30 - < 50 ml/min), an intravenous bolus of 180 microgram/kg should be administered followed by a continuous infusion dose of 1.0 microgram/kg/min for the duration of therapy. 
U bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 do < 50 ml/min), treba primijeniti intravenski bolus od 180 mikrograma/kg nakon kojeg se nastavlja kontinuirana infuzija doze od 1,0 mikrogram/kg/min tijekom cijelog trajanja terapije.
TIMI major bleeding occurred in 2.7 % of patients who received a reduced dose (1microgram/kg/min) vs 4.2 % of patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.36). 
TIMI veliko krvarenje je nastupilo u 2,7 % bolesnika koji su primali smanjenu dozu (1 mikrogram/kg/min) naspram 4,2 % bolesnika na standardnoj dozi (2 mikrogram/kg/min) uz ranu rutinsku primjenu eptifibatida (p=0,36).
Each ml of solution for injection contains 2 mg of eptifibatide. 
Jedan ml otopine za injekciju sadržava 2 mg eptifibatida.
Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti koji je naveden na kutiji i bočici iza oznake Rok valjanosti i EXP.
- if you have or have had difficulty with your blood clotting or a low blood platelet count. 
− ako ste imali ili imate problema s zgrušavanjem krvi ili nizak broj trombocita.
If PCI was performed, the eptifibatide infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours. 
Ako se provodila perkutana koronarna intervencija (PCI), infuzija eptifibatida se nastavila 24 sata nakon zahvata, do ukupno najduže 96 sati.
Eptifibatide Accord 2 mg/ml solution for injection 
Eptifibatid Accord 2 mg/ml otopina za injekciju
Results on the primary endpoint were mainly attributed to the reduction of enzymatic MI occurrence, identified as the occurrence of early elevation of cardiac enzymes after PCI (80 out of 92 MIs in the placebo group vs. 47 out of 56 MIs in the eptifibatide group). 
Rezultati primarne mjere ishoda uglavnom se mogu pripisati smanjenju enzimskih IM, definiranih kao nastup ranog povišenja vrijednosti srčanih enzima nakon PCI (80 od
Package leaflet: Information for the patient Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide 
Uputa o lijeku: Informacije za bolesnika Eptifibatid Accord 0,75 mg/ml otopina za infuziju eptifibatid
Package leaflet: Information for the patient Eptifibatide Accord 2 mg/ml solution for injection eptifibatide 
Uputa o lijeku: Informacije za bolesnika Eptifibatid Accord 2 mg/m lotopina za injekciju eptifibatid
How to store Eptifibatide Accord 
Kako primjenjivati Eptifibatid Accord
Interruption of breast-feeding during the treatment period is recommended. 
Preporučuje se prekinuti dojenje za vrijeme liječenja eptifibatidom.
- If you have any further questions, ask your doctor or hospital pharmacist or nurse. 
- Ako imate dodatnih pitanja, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj sestri.
Eptifibatide Accord 2 mg/ml solution for injection eptifibatide 
Eptifibatid Accord 2 mg/ml otopina za injekciju eptifibatid
There is limited data with regards to platelet inhibition in patients with renal impairment. 
Podaci o inhibiciji trombocita u bolesnika s bubrežnim oštećenjem su ograničeni.
Eptifibatide Accord 0.75 mg/ml solution for infusion 
Eptifibatid Accord 0,75 mg/ml otopina za infuziju
Intravenous use Read the package leaflet before use. 
Za primjenu u venu Prije uporabe pročitajte uputu o lijeku.
Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI). 
Bolesnici su mogli biti nakon liječenja lijekovima proslijeđeni na ugradnju CABG ili podvrgnuti PCI.
In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive. 
ACS ispitivanja ne mogu se izvući zaključci o odnosu rizika i koristi primjene smanjene doze u bolesnika s umjerenim oštećenjem bubrežne funkcije.
One 100 ml vial contains 75 mg of eptifibatide. 
Jedna bočica od 100 ml sadržava 75 mg eptifibatida.
Each ml of solution for infusion contains 0.75 mg of eptifibatide. 
Jedan ml otopine za infuziju sadržava 0,75 mg eptifibatida.
PURSUIT trial The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT. 
PURSUIT je bila pivotalna klinička studija za liječenje nestabilne angine (NA)/ infarkta miokarda bez
One 10 ml vial contains 20 mg of eptifibatide. 
Jedna bočica od 10 ml sadržava 20 mg eptifibatida.
With delayed provisional eptifibatide administration, the TIMI major events were 1.4 % vs 2.0 % in patients who received reduced dose and standard dose respectively (p=0.54).There were no notable differences observed with GUSTO severe bleeding rates. 
Uz odgođenu privremenu primjenu eptifibatida, TIMI velika krvarenja su iznosila 1,4 % u bolesnika koji su primali smanjenu dozu naspram 2,0 % u bolesnika na standardnoj dozi (p=0,54).
Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors. 
Willebrandovog faktora i drugih adhezivnih liganada za receptore glikoproteina (GP) IIb/IIIa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL for 10 ml vial 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Skin and subcutaneous tissue disorders 
Vrlo rijetko anafilaktička reakcija Poremećaji kože i potkožnog tkiva
Eptifibatide Accord 0.75 mg/ml solution for infusion eptifibatide 
Eptifibatid Accord 0,75 mg/ml otopina za infuziju eptifibatid
Patients were managed according to the usual standards of the investigational site; frequencies of angiography, PCI and CABG therefore differed widely from site to site and from country to country. 
PCI i CABG su se stoga dosta razlikovale od centra do centra i od zemlje do zemlje.
If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj sestri.
The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first). 
2 mikrograma/kg/min u trajanju do najviše 72 sata, do početka operacije ugradnje premosnice koronarne arterije (CABG) ili do otpusta iz bolnice (ovisno o tome što se dogodi prije).
One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide. 
Jedna bočica sa 100 ml otopine za infuziju sadržava 75 mg eptifibatida.
Distrobution 
Distribucija
− fatal bleeding. 
Krvožilni poremećaji
UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr. 
Nestabilna angina ili infarkt miokarda bez Q-zupca: Za bolesnika koji teži ≥ 70 kg preporučuje se primjena bolus doze od 5000 jedinica, nakon koje treba uslijediti intravenska infuzija od 1000 jedinica/h.
- prothrombin time > 1.2 times control, or International Normalized Ratio (INR) ≥ 2.0 
− s protrombinskim vremenom > 1,2 puta u odnosu na kontrolnu vrijednost ili INR ≥ 2,0 − s teškom hipertenzijom (sistolički krvni tlak > 200 mm Hg ili dijastolički krvni tlak
If PCI is to be performed in the setting of UA/NQMI, monitor the activated clotting time (ACT) to maintain a value between 300-350 seconds. 
Ako je potrebno u uvjetima nestabilne angine ili infarkta miokarda bez Q-zupca izvesti perkutanu koronarnu angioplastiku, potrebno je pratiti aktivirano vrijeme zgrušavanja (ACT) kako bi se održala vrijednost između 300 i 350 sekundi.
Common side effects These may affect up to 1 in 10 people 
Vrlo rijetke nuspojave Mogu se javiti u dood 1 na 10000 osoba
Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use). 
kad je ACT premašio 350 sekundi (vidjeti dio 4.4., Primjena heparina).
Solution for injection 1 vial of 10 ml 
NALJEPNICA za bočicu od 10 ml
One vial of 10 ml of solution for injection contains 20 mg of eptifibatide. 
Jedna bočica s 10 ml otopine za injekciju sadržava 20 mg eptifibatida.
One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a flip-off aluminium seal. 
Jedna staklena bočica (staklo tipa I) od 100 ml, zatvorena gumenim čepom (butil guma) i aluminijskim
Administration of eptifibatide is associated with an increase in major and minor bleeding as classified by the criteria of the TIMI study group. 
Primjena eptifibatida je povezana s porastom broja velikih i manjih krvarenja klasificiranih prema
One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a flip-off aluminium seal. 
Jedna staklena bočica (staklo tipa I) od 10 ml, zatvorena gumenim čepom (butil guma) i aluminijskim
> 110 mm Hg on antihypertensive therapy) - severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis - clinically significant hepatic impairment - concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor 
− s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili oni koji ovise o dijalizi − s klinički značajnim oštećenjem jetre
Thrombocytopenia, including acute profound thrombocytopenia, has been observed with eptifibatide administration post-marketing (see section 4.8) 
Pri primjeni eptifibatida nakon stavljanja lijeka u promet, zabilježena je trombocitopenija, uključujući akutnu, izraženu trombocitopeniju (vidjeti dio 4.8).
In patients with previous immune-mediated thrombocytopenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of eptifibatide. 
Trombocitopenija i imunogeničnost vezana uz GP IIb/IIIa inhibitore Eptifibatid Accord inhibira agregaciju trombocita, ali čini se da ne utječe na sposobnost preživljavanja trombocita.
APPROPRIATE 
DODATAK
- if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke). 
(također, liječnik svakako mora znati ako ste ikada doživjeli moždani udar).
Nervous System disorders 
Oštećenje bubrega
It is used in two groups of patients: 
Primjenjuje se u dvjema skupinama bolesnika:
Further information on Aranesp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aranesp. 
Više informacija o lijeku Aranesp nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/aranesp.
This overview was last updated in 02-2019. 
Pregled informacija posljednji je put ažuriran u 2. 2019.
The lowest dose that provides adequate control of symptoms should be used. 
Treba se primijeniti najniža doza kojom se postiže odgovarajuća kontrola simptoma.
structure to the natural hormone. 
Strukturom se neznatno razlikuje od prirodnog hormona.
Aranesp received a marketing authorisation valid throughout the EU on 8 June 2001. 
Lijek Aranesp dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 8. lipnja 2001.
What measures are being taken to ensure the safe and effective use of Aranesp? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aranesp?
Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. 
Aranesp je lijek kojim se liječi anemija (nizak broj crvenih krvnih stanica) koja uzrokuje simptome.
• adults who are receiving chemotherapy for non-myeloid cancer (cancer not originating in the bone marrow). 
• u odraslih koji primaju kemoterapiju za nemijeloičnu malignu bolest (rak koji ne potječe iz koštane srži).
Because of the slight changes to the structure, darbepoetin alfa remains in the body for longer than natural erythropoietin. 
Zbog neznatnih promjena u strukturi darbepoetin se u tijelu sadržava duže nego prirodni eritropoetin.
What is Aranesp and what it is used for? 
Što je Aranesp i za što se primjenjuje?
Side effects reported with Aranesp are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Aranesp pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Aranesp must not be used in patients who have poorly controlled high blood pressure. 
Aranesp se ne smije primjenjivati u bolesnika u kojih je visoki krvni tlak slabo kontroliran.
The company that markets Aranesp will provide educational packs for patients and healthcare professionals including information on how to self-inject the medicine, a training checklist and a demonstration device. 
Tvrtka koja lijek Aranesp stavlja u promet osigurat će bolesnicima i zdravstvenim radnicima komplete za obuku koji sadrže informacije o tome kako samostalno ubrizgati lijek, kontrolni popis za obuku i napravu za demonstraciju primjene.
Other information about Aranesp 
Ostale informacije o lijeku Aranesp
The dose and frequency of injection depend on why Aranesp is being used, and are adjusted, according to the patient's response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre). 
Doza i učestalost davanja injekcija ovise o razlogu zbog kojeg se Aranesp primjenjuje te se, ovisno o odgovoru bolesnika, prilagođuju kako bi se postigla razina hemoglobina u preporučenom rasponu (između 10 i 12 grama po decilitru).
In kidney failure patients, the most common side effects with Aranesp (which may affect more than 1 in 10 people) are hypersensitivity (allergy) and hypertension (high blood pressure) while in cancer patients the most common are hypersensitivity and oedema (fluid retention). 
U bolesnika sa zatajenjem bubrega najčešće su nuspojave lijeka Aranesp (koje se mogu javiti u više od 1 u 10 osoba) preosjetljivost (alergija) i hipertenzija (visoki krvni tlak), dok su najčešće nuspojave u osoba oboljelih od raka preosjetljivost i edem (zadržavanje tekućine).
Aranesp can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating the types of anaemia mentioned above. 
Aranesp se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju navedenih vrsta anemije.
As for all medicines, data on the use of Aranesp are continuously monitored. 
Kao i za sve lijekove, podatci o primjeni lijeka Aranesp kontinuirano se prate.
• adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly); 
• u odraslih i djece s kroničnim zatajenjem bubrega (dugotrajnim smanjenjem sposobnosti pravilnog rada bubrega)
Why is Aranesp authorised in the EU? 
Zašto je lijek Aranesp odobren u EU-u?
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of a hormone called erythropoietin, or by the body not responding well enough to erythropoietin. 
Kod bolesnika koji primaju kemoterapiju ili imaju problema s bubrezima anemija može biti prouzročena manjkom hormona eritropoetina ili činjenicom da tijelo ne reagira na eritropoetin na zadovoljavajući način.
The European Medicines Agency decided that Aranesp's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove zaključila je da koristi od lijeka Aranesp nadmašuju s njim povezane rizike te da on može biti odobren za primjenu u Europskoj uniji.
Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels and at keeping these levels maintained, whether given as an injection into a vein or under the skin. 
Bio je jednako učinkovit kao i rekombinantni ljudski eritropoetin u povišenju razina hemoglobina i zadržavanju viših razina, bez obzira na to je li primijenjen injekcijom u venu ili pod kožu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aranesp have also been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Aranesp također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults. 
Lijek Aranesp ispitan je i u 124-ero djece s kroničnim zatajenjem bubrega kako bi se provjerilo apsorbira li se na isti način kao u odraslih.
An overview of Aranesp and why it is authorised in the EU 
Pregled informacija o lijeku Aranesp i zašto je odobren u EU-u
What are the risks associated with Aranesp? 
Koji su rizici povezani s lijekom Aranesp?
Aranesp contains the active substance darbepoetin alfa. 
Aranesp sadrži djelatnu tvar darbepoetin alfa.
In two studies involving 669 patients receiving chemotherapy, Aranesp was more effective than placebo (a dummy treatment) and fewer patients needed a blood transfusion. 
U dvama ispitivanjima kojima je bilo obuhvaćeno 669 bolesnika koji su primali kemoterapiju lijek Aranesp je bio učinkovitiji od placeba (prividnog liječenja).
For more information about using Aranesp, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Aranesp pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
What benefits of Aranesp have been shown in studies? 
Koje su koristi od lijeka Aranesp utvrđene u ispitivanjima?
Aranesp can be injected by the patient or their carer if they have been trained. 
Aranesp mogu primjenjivati i sami bolesnici ili njihovi njegovatelji ako su prošli odgovarajuću obuku.
Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen. 
Lijek Aranesp dostupan je u bočici, napunjenoj štrcaljki ili napunjenoj brizgalici, u različitim jačinama.
For the full list of side effects and restrictions, see the package leaflet 
Potpuni popis nuspojava i ograničenja potražite u uputi o lijeku.
The active substance in Aranesp, darbepoetin alfa works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow. 
Djelatna tvar lijeka Aranesp, darbepoetin alfa, djeluje na potpuno isti način kao prirodni hormon
For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin. 
Bolesnicima s kroničnim zatajenjem bubrega Aranesp se može ubrizgati u venu ili pod kožu, a onima koji primaju kemoterapiju mora se ubrizgati pod kožu.
Aranesp has been shown to be effective in the treatment of chronic renal failure in four studies involving over 1,200 patients. 
U četirima ispitivanjima kojima je bilo obuhvaćeno više od 1 200 bolesnika lijek Aranesp pokazao se učinkovitim u liječenju kroničnog zatajenja bubrega.
1 August 2017 EMA/443893/2017 
1. kolovoza 2017. EMA/443893/2017
• If you have any questions or concerns, speak with your doctor or pharmacist. 
• Ako imate pitanja ili nedoumice, obratite se svojem liječniku ili ljekarniku.
Most cases of allergic reactions occurred in patients under 12 years of age. 
Većina slučajeva alergijskih reakcija zabilježena je u bolesnika mlađih od 12 godina.
On 31 July 2017 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable. 
CMDh je 31. srpnja 2017. donio svoje stajalište konsenzusom te će mjere koje je PRAC preporučio izravno provesti države članice u kojima su ti lijekovi odobreni u skladu s dogovorenim rasporedom.
The above recommendations are based on analyses of spontaneous reports of suspected adverse effects and a review of published literature. 
Prethodno navedene preporuke temelje se na analizama spontano zabilježenih sumnjivih štetnih učinaka i pregledu literature.
This may lead to additional doses being given which will further worsen the patient's condition. 
Zbog toga se bolesniku mogu dati dodatne doze, što će dodatno pogoršati njegovo stanje.
The review of injectable medicines for acute allergic reaction that contain lactose from cows' milk was initiated on 1 December 2016 at the request of Croatia, under Article 31 of Directive 2001/83/EC. 
Preispitivanje lijekova za akutne alergijske reakcije u obliku injekcije koji sadrže laktozu iz kravljeg mlijeka pokrenuto je 1. prosinca 2016. na zahtjev Hrvatske na temelju članka 31. Direktive 2001/83/EZ.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position. 
Preporuka PRAC-a poslana je Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je donijela odluku.
Companies have been asked to provide data allowing the replacement of formulations containing lactose from cow's milk; this data should be provided by the middle of 2019. 
Od poduzeća je zatraženo da dostave podatke s pomoću kojih bi se omogućila zamjena formulacija koje sadrže laktozu iz kravljeg mlijeka; ti bi se podatci trebali dostaviti do sredine 2019.
1 The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) is a medicines regulatory body representing the European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway. 
1 Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) regulatorno je tijelo za lijekove koje zastupa države članice Europske unije (EU) te Island, Lihtenštajn i Norvešku.
Methylprednisolone-containing medicines have been authorised by national procedures for use by injection into a vein or muscle and have been available for many years in the EU under a variety of brand names including Solu-Medrol. 
Lijekovi koje sadrže metilprednizolon odobreni su nacionalnim postupcima za primjenu davanjem injekcije u venu ili mišić i godinama su dostupni u EU-u pod raznim robnim nazivima, uključujući SoluMedrol.