natgillin/translations-raw huggingface dataset:
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Retacrit 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 1,0 ml raztopine za injiciranje vsebuje 10.000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/431/013 1 pre-filled syringe EU/1/07/431/014 6 pre-filled syringes EU/1/07/431/038 1 pre-filled syringe with needle guard EU/1/07/431/039 6 pre-filled syringes with needle guard EU/1/07/431/066 1 pre-filled syringe with needle-trap EU/1/07/431/067 6 pre-filled syringes with needle-trap
Retacrit 8.000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/013 1 napolnjena injekcijska brizga EU/1/07/431/014 6 napolnjenih injekcijskih brizg EU/1/07/431/038 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/039 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/066 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/067 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
Retacrit 5 000 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 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Retacrit 30 000 IU/0.75 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 30.000 i.e./0,75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/431/009 1 pre-filled syringe EU/1/07/431/010 6 pre-filled syringes EU/1/07/431/034 1 pre-filled syringe with needle guard EU/1/07/431/035 6 pre-filled syringes with needle guard EU/1/07/431/062 1 pre-filled syringe with needle-trap EU/1/07/431/063 6 pre-filled syringes with needle-trap
Retacrit 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/009 1 napolnjena injekcijska brizga EU/1/07/431/010 6 napolnjenih injekcijskih brizg EU/1/07/431/034 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/035 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/062 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/063 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
Chemotherapy-induced anaemia
Anemija, ki jo je povzročila kemoterapija
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 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/007 1 napolnjena injekcijska brizga EU/1/07/431/008 6 napolnjenih injekcijskih brizg EU/1/07/431/032 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/033 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/060 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/061 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
1 pre-filled syringe without needle guard containing 0.5 ml solution for injection Component of a multipack, not to be sold separately.
1 napolnjena injekcijska brizga brez pripomočka za zaščito igle, ki vsebuje 0,5 ml raztopine za injiciranje
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Retacrit 40.000 i.e./1 ml raztopine za injiciranje v napolnjeni injekcijski brizgi epoetin zeta
Appropriate dose adjustments should be made to maintain haemoglobin concentrations within the target range of 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Odmerek je treba ustrezno prilagajati za ohranjanje koncentracije hemoglobina znotraj ciljnega razpona med 10 g/dl in 12 g/dl (6,2 - 7,5 mmol/l).
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Retacrit 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 6.000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
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 1.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/001 1 napolnjena injekcijska brizga EU/1/07/431/002 6 napolnjenih injekcijskih brizg EU/1/07/431/026 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/027 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/054 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/055 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
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 3.000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/005 1 napolnjena injekcijska brizga EU/1/07/431/006 6 napolnjenih injekcijskih brizg EU/1/07/431/030 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/031 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/058 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/059 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
Excipients with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Pomožne snovi z znanim učinkom: Ena napolnjena injekcijska brizga vsebuje 0,40 mg fenilalanina.
Excipients with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Pomožne snovi z znanim učinkom: Ena napolnjena injekcijska brizga vsebuje 0,30 mg fenilalanina.
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 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/011 1 napolnjena injekcijska brizga EU/1/07/431/012 6 napolnjenih injekcijskih brizg EU/1/07/431/036 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/037 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/064 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/065 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Retacrit 1.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 1.000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Retacrit 10 000 IU injection epoetin zeta
Retacrit 10.000 i.e. injekcija epoetin zeta i.v.
Excipients with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Pomožne snovi z znanim učinkom: Ena napolnjena injekcijska brizga vsebuje 0,15 mg fenilalanina.
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 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Retacrit 3 000 IU injection epoetin zeta
Retacrit 3.000 i.e. injekcija epoetin zeta i.v.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Retacrit 2.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 2.000 mednarodnih enot (i.e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe epoetin zeta
Retacrit 1.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin zeta
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/431/015 1 pre-filled syringe EU/1/07/431/016 6 pre-filled syringes EU/1/07/431/040 1 pre-filled syringe with needle guard EU/1/07/431/041 6 pre-filled syringes with needle guard EU/1/07/431/068 1 pre-filled syringe with needle-trap EU/1/07/431/069 6 pre-filled syringes with needle-trap
Retacrit 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/015 1 napolnjena injekcijska brizga EU/1/07/431/016 6 napolnjenih injekcijskih brizg EU/1/07/431/040 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/041 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/068 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/069 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
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).
Odmerek je treba ustrezno prilagoditi, da se koncentracija hemoglobina ohranja v želenem razponu koncentracije med 10 g/dl in 12 g/dl (od 6,2 do 7,5 mmol/l).
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).
Izvesti je treba ustrezno prilagajanje odmerka, da se vrednost hemoglobina ohranja v želenem razponu koncentracije med 10 g/dl in 12 g/dl (od 6,2 do 7,5 mmol/l).
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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/431/019 1 napolnjena injekcijska brizga EU/1/07/431/024 4 napolnjene injekcijske brizge EU/1/07/431/025 6 napolnjenih injekcijskih brizg EU/1/07/431/044 1 napolnjena injekcijska brizga s pripomočkom za zaščito igle EU/1/07/431/049 4 napolnjene injekcijske brizge s pripomočkom za zaščito igle EU/1/07/431/050 6 napolnjenih injekcijskih brizg s pripomočkom za zaščito igle EU/1/07/431/053 4 (4x1) napolnjene injekcijske brizge (skupno pakiranje) EU/1/07/431/076 1 napolnjena injekcijska brizga z varovalnim nastavkom Needle-Trap EU/1/07/431/077 4 napolnjene injekcijske brizge z varovalnim nastavkom Needle-Trap EU/1/07/431/078 6 napolnjenih injekcijskih brizg z varovalnim nastavkom Needle-Trap
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 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Excipients with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Pomožne snovi z znanim učinkom: Ena napolnjena injekcijska brizga vsebuje 0,50 mg fenilalanina.
• Diarrhoea
• Driska.
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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
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 3.000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
In healthy subjects, a dose-proportional increase in serum erythropoietin concentrations was observed after intravenous administration of 150 and 300 IU/kg, 3 times per week.
Pri zdravih preskušancih so po intravenskem dajanju 150 in 300 i.e./kg trikrat na teden opazili z odmerkom sorazmerno povečanje serumskih koncentracij epoetina alfa.
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 2.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
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 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjeni injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s apripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Antibody-mediated pure red cell aplasia (PRCA) has been reported after months to years of treatment with epoetins.
Po več mesecih ali letih zdravljenja z epoetini so poročali o pojavu PRCA, do katere je prišlo zaradi protiteles.
but away from the navel.
(abdomna), vendar ne blizu popka.
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 1.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Napolnjena injekcijska brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko s pripomočkom za zaščito igle ali brez njega ali z varovalnim nastavkom Needle-Trap.
Retacrit 1 000 IU injection epoetin zeta
Retacrit 1.000 i.e. injekcija epoetin zeta i.v.
Please tell your doctor about any of these things.
Če imate karkoli od navedenega, o tem obvestite zdravnika.
A sustained haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustment for when haemoglobin concentrations exceed 12 g/dL (7.5 mmol/L) are described below.
Navodila za primerno prilagajanje odmerka v primeru ugotovljenih koncentracij hemoglobina, ki presegajo 12 g/dl (7,5 mmol/l), so navedena spodaj.
Weight (kg)
300 i.e./kg
More cases have been reported with subcutaneous (SC) route of administration, compared with the IV route.
Pri subkutani uporabi so poročali o več primerih kot pri intravenski uporabi.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti kongestija dihal občasni
Haemoglobin (g/L)
≤ 12 g/dl
28 patches (7x 2mg/24h, 7x 4mg/24h, 7x 6mg/24h, 7x 8mg/24h)
Transdermalni obliž transdermalnih obližev (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)
Pot uporabe Stična ovojnina
24 October 2011
24. oktober 2011
The European Commission issued a decision on 24 October 2011.
Evropska komisija je sklep izdala dne 24. oktobra 2011.
It is available as an oral solution (0.4 mg/ml).
Na voljo je v obliki peroralne raztopine (0,4 mg/ml).
EMA/863769/2011 Rev.1 EMEA/H/A-29/1308
EMA/CHMP/582483/2011 rev.1 EMEA/H/A-29/1308
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.
Vendar države članice niso mogle doseči soglasja in malteška regulativna agencija za zdravila je dne 30. maja 2011 zadevo napotila na CHMP v arbitražo.
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).
To je postopek, ko ena država članica („referenčna država članica“, v tem primeru Malta) presoja zdravilo z vidika odobritve dovoljenja za promet, ki bo veljavno v omenjeni državi in v drugih državah članicah („zadevne države članice“, v tem primeru Belgija, Bolgarija, Ciper, Nemčija, Grčija, Portugalska, Romunija in Združeno Kraljestvo).
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).
Zdravilo Dexamethasone Alapis se uporablja predvsem kot protivnetno in imunosupresivno zdravilo (zdravilo, ki zmanjša aktivnost imunskega sistema) pri številnih boleznih, ki prizadenejo različne dele telesa, vključno s krvjo, jetri, ledvicami, želodcem in črevesjem, mišicami, očmi, pljuči in kožo, ter pri določenih vrstah raka in obvladovanju anafilakse (hude alergijske reakcije).
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.
Evropska agencija za zdravila je zaključila arbitražni postopek po nestrinjanju držav članic Evropske unije (EU) glede odobritve zdravila Dexamethasone Alapis.
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.
Deluje tako, da vstopi v celico in zavira nastajanje žilnega endotelnega rastnega faktorja (VEGF) in prostaglandinov, snovi, ki sodelujejo pri vnetju in otekanju.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Dexamethasone Alapis odtehtajo z njim povezana tveganja in da se lahko dovoljenje za promet z zdravilom odobri na Malti in v naslednjih državah članicah Evropske unije: Belgiji, Bolgariji, na Cipru, v Nemčiji, Grčiji, na Portugalskem, v Romuniji in Združenem kraljestvu.
Why was Dexamethasone Alapis reviewed?
Zakaj je bilo zdravilo Dexamethasone Alapis pregledano?
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.
Nemška regulativna agencija za zdravila je menila, da podatki, predloženi v podporo vlogi, ne dokazujejo varnosti in učinkovitosti zdravila Dexamethasone Alapis v zadostni meri.
What is Dexamethasone Alapis?
Kaj je zdravilo Dexamethasone Alapis?
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.
CHMP je po vrednotenju trenutno razpoložljivih podatkov in znanstveni razpravi v Odboru menil, da predloženi podatki zadostujejo za dokaz, da se lahko zdravilo Dexamethasone Alapis uporablja varno in učinkovito na osnovi dobro uveljavljene uporabe deksametazona.
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.
CHMP je zato zaključil, da koristi zdravila Dexamethasone Alapis odtehtajo z njim povezana tveganja, zato se lahko dovoljenje za promet odobri v vseh zadevnih državah članicah.
The active substance in Dexamethasone Alapis, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids.
Zdravilna učinkovina v zdravilu Dexamethasone Alapis, deksametazon, spada v skupino protivnetnih zdravil, imenovanih kortikosteroidi.
Dexamethasone Alapis is a medicine that contains the active substance dexamethasone.
Dexamethasone Alapis je zdravilo, ki vsebuje zdravilno učinkovino deksametazon.