natgillin/translations-raw huggingface dataset:
1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin). 
1 napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 1000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe EU/1/07/431/007 1 pre-filled syringe EU/1/07/431/008 6 pre-filled syringes EU/1/07/431/032 1 pre-filled syringe with needle guard EU/1/07/431/033 6 pre-filled syringes with needle guard EU/1/07/431/060 1 pre-filled syringe with needle-trap EU/1/07/431/061 6 pre-filled syringes with needle-trap 
Retacrit 4000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/007 1 napunjena štrcaljka EU/1/07/431/008 6 napunjenih štrcaljki EU/1/07/431/032 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/033 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/060 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/061 6 napunjenih štrcaljki bez klopke za iglu
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/431/011 1 pre-filled syringe EU/1/07/431/012 6 pre-filled syringes EU/1/07/431/036 1 pre-filled syringe with needle guard EU/1/07/431/037 6 pre-filled syringes with needle guard EU/1/07/431/064 1 pre-filled syringe with needle-trap EU/1/07/431/065 6 pre-filled syringes with needle-trap 
Retacrit 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/011 1 napunjena štrcaljka EU/1/07/431/012 6 napunjenih štrcaljki EU/1/07/431/036 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/037 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/064 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/065 6 napunjenih štrcaljki bez klopke za iglu
Excipients with known effect Each pre-filled syringe contains 0.45 mg phenylalanine. 
Pomoćne tvari s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,45 mg fenilalanina.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe epoetin zeta 
Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki epoetin zeta
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe EU/1/07/431/005 1 pre-filled syringe EU/1/07/431/006 6 pre-filled syringes EU/1/07/431/030 1 pre-filled syringe with needle guard EU/1/07/431/031 6 pre-filled syringes with needle guard EU/1/07/431/058 1 pre-filled syringe with needle-trap EU/1/07/431/059 6 pre-filled syringes with needle-trap 
Retacrit 3000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/005 1 napunjena štrcaljka EU/1/07/431/006 6 napunjenih štrcaljki EU/1/07/431/030 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/031 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/058 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/059 6 napunjenih štrcaljki bez klopke za iglu
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe 
Retacrit 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 4000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka sa staklom tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/431/001 1 pre-filled syringe EU/1/07/431/002 6 pre-filled syringes EU/1/07/431/026 1 pre-filled syringe with needle guard EU/1/07/431/027 6 pre-filled syringes with needle guard EU/1/07/431/054 1 pre-filled syringe with needle-trap EU/1/07/431/055 6 pre-filled syringes with needle-trap 
Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/001 1 napunjena štrcaljka EU/1/07/431/002 6 napunjenih štrcaljki EU/1/07/431/026 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/027 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/054 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/055 6 napunjenih štrcaljki bez klopke za iglu
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe epoetin zeta 
Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki epoetin zeta
Use an antiseptic swab on the injection site, to disinfect it. 
Dezinficirajte kožu na mjestu injekcije aseptičkom maramicom.
Diarrhoea, Nausea, Vomiting Very common 
zimice, umora i omaglice.
Surgery patients in autologous predonation programmes 
Kirurški bolesnici u programu autologne predonacije
Appropriate adjustment of the dose should be made in order to maintain haemoglobin concentrations within the desired concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L). 
Potrebno je odgovarajuće prilagoditi dozu radi održavanja koncentracije hemoglobina unutar željenog raspona između 10 g/dl i 12 g/dl (6,2 - 7,5 mmol/l).
Excipients with known effect Each pre-filled syringe contains 0.30 mg phenylalanine. 
Pomoćne tvari s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,30 mg fenilalanina.
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
1 pre-filled syringe without needle guard containing 0.5 ml solution for injection 6 pre-filled syringes without needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle guard containing 0.5 ml solution for injection 6 pre-filled syringes with needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.5 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.5 ml solution for injection 
1 napunjena štrcaljka bez štitnika za iglu s 0,5 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 0,5 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 0,5 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 0,5 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 0,5 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 0,5 ml otopine za injekciju
Excipients with known effect Each pre-filled syringe contains 0.40 mg phenylalanine. 
Pomoćne tvari s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,40 mg fenilalanina.
Appropriate adjustment of the dose should be made in order to maintain haemoglobin values within the desired concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L). 
Potrebno je provesti odgovarajuću prilagodbu doze radi održanja vrijednosti hemoglobina unutar željenog raspona koncentracij e, između 10 g/dl i 12 g/dl (6,2 - 7,5 mmol/l).
1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin). 
1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 2000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe 
Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki
1 pre-filled syringe contains 1 000 IU epoetin zeta. 
1 napunjena štrcaljka sadrži 1000 IU epoetina zeta.
A less defined profile was observed for RBCs and haemoglobin. 
Za crvene krvne stanice i hemoglobin, profil krivulje bio je slabije definiran.
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/431/019 1 pre-filled syringe EU/1/07/431/024 4 pre-filled syringes EU/1/07/431/025 6 pre-filled syringes EU/1/07/431/044 1 pre-filled syringe with needle guard EU/1/07/431/049 4 pre-filled syringes with needle guard EU/1/07/431/050 6 pre-filled syringes with needle guard EU/1/07/431/053 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/076 1 pre-filled syringe with needle-trap 
Retacrit 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/019 1 napunjena štrcaljka EU/1/07/431/024 4 napunjene štrcaljke EU/1/07/431/025 6 napunjenih štrcaljki EU/1/07/431/044 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/049 4 napunjene štrcaljke sa štitnikom za iglu EU/1/07/431/050 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/053 4 (4 x 1) napunjene štrcaljke (višestruko pakiranje) EU/1/07/431/076 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/077 4 napunjene štrcaljke s klopkom za iglu EU/1/07/431/078 6 napunjenih štrcaljki bez klopke za iglu
1 pre-filled syringe without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection 
1 napunjena štrcaljka bez štitnika za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 1 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 1 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 1 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 1 ml otopine za injekciju
1 pre-filled syringe without needle guard containing 0.3 ml solution for injection 6 pre-filled syringes without needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle guard containing 0.3 ml solution for injection 6 pre-filled syringes with needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.3 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.3 ml solution for injection 
1 napunjena štrcaljka bez štitnika za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 0,3 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 0,3 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 0,3 ml otopine za injekciju
1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection 6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection 
1 napunjena štrcaljka bez štitnika za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki bez štitnika za iglu s 0,6 ml otopine za injekciju 1 napunjena štrcaljka sa štitnikom za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki sa štitnikom za iglu s 0,6 ml otopine za injekciju 1 napunjena štrcaljka s klopkom za iglu s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki s klopkom za iglu s 0,6 ml otopine za injekciju
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 3000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
Excipients with known effect Each pre-filled syringe contains 0.50 mg phenylalanine. 
Pomoćne tvari s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,50 mg fenilalanina.
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
If you get any side effects, talk to your doctor, pharmacist or nurse. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/431/003 1 pre-filled syringe EU/1/07/431/004 6 pre-filled syringes EU/1/07/431/028 1 pre-filled syringe with needle guard EU/1/07/431/029 6 pre-filled syringes with needle guard EU/1/07/431/056 1 pre-filled syringe with needle-trap EU/1/07/431/057 6 pre-filled syringes with needle-trap 
Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/431/003 1 napunjena štrcaljka EU/1/07/431/004 6 napunjenih štrcaljki EU/1/07/431/028 1 napunjena štrcaljka sa štitnikom za iglu EU/1/07/431/029 6 napunjenih štrcaljki bez štitnika za iglu EU/1/07/431/056 1 napunjena štrcaljka s klopkom za iglu EU/1/07/431/057 6 napunjenih štrcaljki bez klopke za iglu
Retacrit 30 000 IU injection epoetin zeta 
Retacrit 30 000 IU injekcija epoetin zeta i.v./s.c.
Adults scheduled for major orthopaedic surgery 
Odrasli u kojih se planira velika ortopedska operacija
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when ESAs were administered to achieve a haemoglobin concentration level of greater than 12 g/dL (7.5 mmol/L). 
U bolesnika s kroničnim zatajenjem bubrega, održavana koncentracija hemoglobina ne smije prelaziti gornju granicu raspona koncentracije hemoglobina preporučenog u dijelu 4.2. U kliničkim ispitivanjima opažen je povećan rizik od smrti i ozbiljnih kardiovaskularnih događaja kada su za postizanje razine koncentracije hemoglobina veće od 12 g/dl (7,5 mmol/l) primjenjivani ESA lijekovi.
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
Retacrit 4 000 IU injection epoetin zeta 
Retacrit 4000 IU injekcija epoetin zeta i.v./s.c.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe 
Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki
Retacrit 2 000 IU injection epoetin zeta 
Retacrit 2000 IU injekcija epoetin zeta i.v./s.c.
It is important to tell your doctor if any of the following apply to you. 
Ako se nešto od sljedećeg odnosi na Vas, važno je da to kažete svom liječniku.
Retacrit 40 000 IU injection epoetin zeta 
Retacrit 40 000 IU injekcija epoetin zeta i.v./s.c.
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 1000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
Serum electrolytes should be monitored in chronic renal failure patients. 
U bolesnika s kroničnim zatajenjem bubrega potrebno je pratiti elektrolite u serumu.
Retacrit 10 000 IU injection epoetin zeta 
Retacrit 10 000 IU injekcija epoetin zeta i.v./s.c.
Retacrit 3 000 IU injection epoetin zeta 
Retacrit 3000 IU injekcija epoetin zeta i.v./s.c.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device. 
Retacrit 2000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Napunjena štrcaljka od stakla tipa I, s pričvršćenom čeličnom iglom za injekciju i čepom klipa obloženim politetrafluoroetilenom (PTFE-om) sa ili bez štitnika za iglu ili s klopkom za iglu.
Retacrit 6 000 IU injection epoetin zeta 
Retacrit 6000 IU injekcija epoetin zeta i.v./s.c.
6.4 Special precautions for storage 
Posebne mjere pri čuvanju lijeka
28 patches (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h) 
28 flastera (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
Transdermal patch Transdermal use sachet (paper/LDPE/alu/ET copolymer PE/Alu/ ET copolymer/paper) 
Transdermalni flaster
The European Commission issued a decision on 24 October 2011. 
Europska komisija izdala je odluku dana 5. rujna 2013.
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended 
Ishod postupka sukladno članku 29. Direktive 2001/83/EC s izmjenama
24 October 2011 
5. rujna 2013.
It is available as an oral solution (0.4 mg/ml). 
Dostupan je kao oralna otopina (6mg/ml).
However, the Member States were not able to reach an agreement and the Maltese medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011. 
No, države članice nisu postigle dogovor i Ujedinjena Kraljevina je uputila predmet CHMP-u na arbitražu dana 5. ožujka 2013. godine.
The CHMP concluded that the benefits of Dexamethasone Alapis outweigh its risks, and therefore the marketing authorisation for Dexamethasone Alapis should be granted in all concerned Member States. 
Stoga je CHMP zaključio da prednosti lijeka Okrido nadmašuju njegove rizike, te se shodno tome odobrenje za stavljanje u promet lijeka Okrido treba odobriti u svim državama članicama sudionicama u postupku.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted was sufficient to show that Dexamethasone Alapis could be used safely and effectively based on the well established use of dexamethasone. 
Na temelju ocjene trenutno dostupnih podataka i znanstvene rasprave unutar Povjerenstva, CHMP je zaključio da se na temelju dostavljenih podataka očekuje da Okrido stvara razine djelatne tvari u tijelu usporedive s referentnim lijekom.
Why was Dexamethasone Alapis reviewed? 
Zašto je proveden pregled lijeka Okrido?
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamethasone Alapis. 
Dana 27. lipnja 2013. godine, Europska agencija za lijekove zaključila je arbitražni postupak nakon neslaganja država članica Europske unije (EU) u svezi s odobrenjem lijeka Okrido.
Dexamethasone Alapis is intended for use principally as an anti-inflammatory or immunosuppressant (a medicine that reduces the activity of the immune system) in a range of specific disorders affecting different parts of the body, including the blood, liver, kidney, stomach and gut, muscles, eye, lungs and skin, as well as in certain cancers and in the management of anaphylaxis (severe allergic reaction). 
• bolesti pluća (uključujući astmu), gornjih dišnih putova (krupa), krvnih žila i srca, crijeva ili bubrega, mišića i zglobova (uključujući reumatoidni artritis) odnosno oka ili živčanog sustava;
Dexamethasone Alapis is a medicine that contains the active substance dexamethasone. 
Okrido je lijek koji sadrži djelatnu tvar prednisolon natrijev fosfat.
The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids. 
Djelatna tvar u lijeku Okrido - prednisolon natrijev fosfat, ubraja se u grupu lijekova pod nazivom glukokortikoidi, koji su tvari koje pomažu u smanjivanju upale.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Dexamethasone Alapis outweigh its risks, and the marketing authorisation can be granted in Malta and in the following Member States of the EU: Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom. 
Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da koristi lijeka Okrido nadmašuju s njim povezane rizike, te da se odobrenje za stavljanje lijeka u promet izdano u Ujedinjenoj Kraljevini može priznati u drugim državama članicama EU-a.
This is a procedure where one Member State (the ‘reference Member State', in this instance Malta) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Portugal, Romania and the United Kingdom). 
Tvrtka je zatražila priznavanje odobrenja u Njemačkoj i Nizozemskoj („države članice sudionice u postupku”).
The German medicines regulatory authority was of the opinion that the data submitted to support the application did not provide sufficient evidence to demonstrate the safety and effectiveness of Dexamethasone Alapis. 
Pharmapol Arzneimittelvertrieb GmbH podnio je za Okrido zahtjev za međusobno priznavanje na temelju prvotnog odobrenja koje je izdala Regulatorne agencije za lijekove i zdravstvene proizvode Ujedinjene Kraljevine dana 19. travnja 2010. godine.
What is Dexamethasone Alapis? 
Što je Okrido?
It works by entering cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling. 
Pitanja i odgovori o lijeku Okrido (prednisolon natrijev fosfat, oralna otopina, 6 mg/ml)
The grounds for the referral were that the application, which was supported by published literature rather than studies carried out with Dexamethasone Alapis, because dexamethasone has a history of well-established use in the EU for at least 10 years, was mainly supported by literature demonstrating the safety and efficacy of dexamethasone in tablet form rather than oral solution form and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of the oral solution form. 
Prosljeđivanje se temeljilo na činjenici da nije dostavljeno dovoljno podataka koji potvrđuju da Okrido stvara razine djelatne tvari u tijelu usporedive s topivim tabletama Prednisolone 5 mg proizvođača Sovereign.
It is given once every three weeks as an infusion lasting 10 minutes. 
Lijek se daje jednom svaka tri tjedna u obliku infuzije koja traje 10 minuta.
The recommended dose is 500 mg per square metre of body surface area (calculated using the patient's height and weight). 
Preporučena doza lijeka iznosi 500 mg/m2 tjelesne površine (izračunata na temelju bolesnikove visine i težine).
The full EPAR and risk management plan summary for Pemetrexed Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) kao i plan upravljanja rizikom nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.