FrancophonIA/ELRC3.0 huggingface dataset:
English: NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection Epoetin beta
Slovenian: NeoRecormon 50.000 i.e. liofilizat in vehikel za večodmerno raztopino za injiciranje epoetin beta
English: Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine,
Slovenian: sečnina, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid,
English: One ml of reconstituted solution contains 5000 IU epoetin beta.
Slovenian: En ml pripravljene raztopine vsebuje 5000 i.e. epoetina beta.
English: These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
Slovenian: Bolnikov, za katere sumimo ali za katere je potrjeno, da imajo nevtralizirajoča protitelesa proti eritropoetinu, ne smemo začeti zdraviti z zdravilom NeoRecormon (glejte poglavje 4.8).
English: 1 prefilled syringe with one needle (27G1/2) or 6 pre-filled syringes with 6 needles (27G1/2).
Slovenian: 1 napolnjena injekcijska brizga z eno iglo (27G1/2) ali 6 napolnjenih injekcijskih brizg s 6 iglami (27G1/2).
English: One ml solution for injection contains 10,000 IU epoetin beta.
Slovenian: En ml raztopine za injiciranje vsebuje 10.000 i.e. epoetina beta.
English: In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4).
Slovenian: Pri večini bolnikov spremlja povečanje hematokrita padec feritina v serumu (glejte poglavje 4.4).
English: · Keep this medicine out of the sight and reach of children.
Slovenian: • Zdravilo shranjujte nedosegljivo otrokom!
English: NeoRecormon Multidose 50,000 IU 5000 IU/ ml
Slovenian: neorecormon 50.000 i.e.
English: Remove the cap from the syringe.
Slovenian: Odstranite pokrovček z brizge.
English: 6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2)
Slovenian: 6 napolnjenih injekcijskih brizg (0,3 ml) in 6 injekcijskih igel (30G1/2)
English: NeoRecormon 5000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 5000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 5000 mednarodnih enot (i.e.), kar ustreza 41,5 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Slovenian: Meta analiza podatkov o celokupnem preživetju je podala oceno razmerja ogroženosti 1,06 v dobro kontrolne skupine (95-% interval zaupanja: 1,00, 1,12; 53 preskušanj in 13.933 bolnikov).
English: INFORMATION IN BRAILLE neorecormon 30.000 IU
Slovenian: PODATKI V BRAILLOVI PISAVI neorecormon 30.000 i.e.
English: NeoRecormon Multidose is a lyophilisate and solvent for solution for injection.
Slovenian: Večodmerno zdravilo NeoRecormon je na voljo kot liofilizat in vehikel za raztopino za injiciranje.
English: If you think you have been injected more NeoRecormon than you should, contact your doctor.
Slovenian: Če so vam injicirali prevelik odmerek zdravila NeoRecormon Če mislite, da so vam injicirali več zdravila NeoRecormon, kot bi smeli, obvestite zdravnika.
English: · Do not hold the plunger while you remove the needle cap. · Do not touch the needle after removing the needle cap. · Do not re-cap the needle.
Slovenian: • Ko odstranite pokrovček igle, se igle ne dotikajte.
English: · 1 dry sterile pad.
Slovenian: • 1 alkoholni zloženec • 1 suha sterilna blazinica
English: INFORMATION IN BRAILLE neorecormon 3000 IU
Slovenian: PODATKI V BRAILLOVI PISAVI neorecormon 3000 i.e.
English: How to store NeoRecormon · Keep this medicine out of the sight and reach of children.
Slovenian: Kako uporabljati zdravilo NeoRecormon Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 2000 IU injection epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE NeoRecormon 2000 i.e. injekcija epoetin beta i.v./s.c.
English: Vascular disorders
Slovenian: Organski sistem
English: An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Slovenian: V in vitro pogojih (celična kultura mišje vranice) so ugotovili povečan obseg vgrajevanja
English: 1 pre-filled syringe (0.3 ml) and 1 needle (30G1/2)
Slovenian: 1 napolnjena injekcijska brizga (0,3 ml) in 1 injekcijska igla (30G1/2)
English: NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 2000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 2000 mednarodnih enot (i.e.), kar ustreza 16,6 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: NeoRecormon 10,000 IU, NeoRecormon 20,000 IU and NeoRecormon 30,000 IU solution for injection in pre-filled syringe
Slovenian: NeoRecormon 10.000 i.e., NeoRecormon 20.000 i.e. in NeoRecormon 30.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 0,6 ml raztopine.
English: NeoRecormon 30,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 30,000 international units (IU) corresponding to 250 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 30.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 30.000 mednarodnih enot (i.e.), kar ustreza 250 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 20,000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 20.000 i.e. napolnjena injekcijska brizga
English: NeoRecormon 20,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 20.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 20.000 mednarodnih enot (i.e.), kar ustreza 166 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 500 i.e. napolnjena injekcijska brizga
English: Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon.
Slovenian: Pred injiciranjem zdravila NeoRecormon morate biti prepričani, da ste prebrali navodila za dajanje zdravila in navodilo za uporabo, jih razumeli in jih boste upoštevali.
English: (2) Place a 26G needle onto an appropriate single-use syringe (max.1 ml).
Slovenian: (2) Na brizgo za enkratno uporabo (največ 1 ml) namestite iglo 26G.
English: NeoRecormon 500 IU NeoRecormon 2000 IU NeoRecormon 3000 IU NeoRecormon 4000 IU NeoRecormon 5000 IU NeoRecormon 6000 IU NeoRecormon 10,000 IU NeoRecormon 20,000 IU NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 500 i.e. NeoRecormon 2000 i.e. NeoRecormon 3000 i.e. NeoRecormon 4000 i.e. NeoRecormon 5000 i.e. NeoRecormon 6000 i.e. NeoRecormon 10.000 i.e. NeoRecormon 20.000 i.e. NeoRecormon 30.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ʽbrez natrija'.
English: Keep the pre-filled syringe in the outer carton, in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5000 IU/1 ml
Slovenian: 5000 i.e./1 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 20,000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 20.000 i.e. epoetina beta.
English: NeoRecormon can be administered through 2 manners, your doctor will decide which way is right for you: · Intravenous administration (into the vein or vein port), only to be performed by healthcare professionals.
Slovenian: Zdravilo NeoRecormon lahko uporabljate na dva načina, vaš zdravnik se bo odločil, kateri način je pravi za vas:
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 6000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 6000 i.e. napolnjena injekcijska brizga
English: The dosage may be raised after 4 weeks to 80 IU/kg three times per week - and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.
Slovenian: Po 4 tednih lahko odmerek povečamo na 80 i.e./kg telesne mase 3-krat na teden.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 2000 i.e. napolnjena injekcijska brizga
English: One ml solution for injection contains 50,000 IU epoetin beta.
Slovenian: En ml raztopine za injiciranje vsebuje 30.000 i.e. epoetina beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 6000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 6000 i.e. epoetina beta.
English: Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
Slovenian: Pri bolnikih s kronično ledvično boleznijo, pri katerih obstaja tveganje obvodne tromboze, so priporočljivi zgodnji pregledi obvodov in preprečevanje nastajanja krvnih strdkov, na primer z acetilsalicilno kislino.
English: NeoRecormon 4000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 4000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 4000 mednarodnih enot (i.e.), kar ustreza 33,2 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 5000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 5000 i.e. epoetina beta.
English: If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether treatment is right for you.
Slovenian: Če ste bolnik z nefrosklerozo in niste na dializi, bo zdravnik odločil o tem, ali je zdravljenje za vas primerno ali ne, ker ne moremo s popolno gotovostjo izključiti možnosti pospešenega napredovanja ledvične bolezni.
English: 4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
Slovenian: 4 napolnjene injekcijske brizge (0,6 ml) in 4 injekcijske igle (27G1/2)
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 5000 i.e. napolnjena injekcijska brizga
English: This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Slovenian: Pri nedonošenčkih možnega tveganja, da bi eritropoetin povzročil retinopatijo, ni mogoče izključiti, zato je potrebna previdnost.
English: NeoRecormon 500 IU, NeoRecormon 2000 IU, NeoRecormon 3000 IU, NeoRecormon 4000 IU, NeoRecormon 5000 IU and NeoRecormon 6000 IU solution for injection in pre-filled syringe
Slovenian: NeoRecormon 500 i.e., NeoRecormon 2000 i.e., NeoRecormon 3000 i.e., NeoRecormon 4000 i.e.,
English: You must talk to your doctor if you do not feel better or if you feel worse.
Slovenian: Če se znaki vaše bolezni poslabšajo ali ne izboljšajo, se posvetujte z zdravnikom.
English: 1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections.
Slovenian: 1 injekcijska brizga vsebuje: sečnino, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, kalcijev klorid dihidrat, glicin, L-levcin, L-izolevcin, L-treonin, L-glutaminsko kislino, L-fenilalanin in vodo za injekcije.
English: Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.1 mmol/l).
Slovenian: Če koncentracija hemoglobina naraste nad 13 g/dl (8,1 mmol/l), je zdravljenje z zdravilom NeoRecormon treba začasno prekiniti.
English: NeoRecormon 10,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 10.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,6 ml raztopine za injiciranje vsebuje 10.000 mednarodnih enot (i.e.), kar ustreza 83 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: Supplies needed to give your injection Included in the carton: · NeoRecormon pre-filled syringe(s).
Slovenian: Vključeni v pakiranju: • napolnjena injekcijska brizga ali napolnjene injekcijske brizge zdravila NeoRecormon
English: 1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2)
Slovenian: 1 napolnjena injekcijska brizga (0,3 ml) in 1 injekcijska igla (27G1/2)
English: For epoetin beta no clinical data on exposed pregnancies are available.
Slovenian: Ni podatkov o uporabi zdravila NeoRecormon pri nosečnicah.
English: Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
Slovenian: Iztisnite zrak iz brizge tako, da jo obrnete z iglo navzgor in rahlo potisnete bat.
English: NeoRecormon 6000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 6000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 6000 mednarodnih enot (i.e.), kar ustreza 49,8 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: · Do not touch the injection site again before giving the injection.
Slovenian: • Pred injiciranjem se ne dotikajte mesta injiciranja.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 2000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 2000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION NeoRecormon 500 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) corresponding to 4.15 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 500 mednarodnih enot (i.e.), kar ustreza 4,15 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: NeoRecormon 3000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin).
Slovenian: NeoRecormon 3000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga z 0,3 ml raztopine za injiciranje vsebuje 3000 mednarodnih enot (i.e.), kar ustreza 24,9 mikrogramom epoetina beta* (rekombinantni humani eritropoetin).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 20,000 IU injection epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE NeoRecormon 20.000 i.e. injekcija epoetin beta i.v./s.c.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Slovenian: Smernice za ustrezno prilagajanje odmerkov, ko koncentracija hemoglobina preseže 12 g/dl (7,5 mmol/), so opisane spodaj.
English: How to store NeoRecormon
Slovenian: Shranjevanje zdravila NeoRecormon
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 4000 i.e. napolnjena injekcijska brizga
English: White lyophilisate and clear, colourless solvent.
Slovenian: Bel liofilizat in bister, brezbarven vehikel.
English: · Do not try to take the syringe apart at any time.
Slovenian: • Injekcijske brizge nikoli ne poskušajte razstaviti.
English: Withdraw all the solvent into the syringe.
Slovenian: Odtrgajte vrh ampule in zajemite ves vehikel v brizgo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 2000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 2000 i.e. epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 20.000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: 6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
Slovenian: 6 napolnjenih injekcijskih brizg (0,3 ml) in 6 injekcijskih igel (27G1/2)
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 30.000 i.e. napolnjena injekcijska brizga
English: Keep the pre-filled syringe in the outer carton, in order to protect from light
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: - Subcutaneous administration:
Slovenian: Korekcijska stopnja - Subkutano dajanje:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 30.000 i.e. epoetina beta.
English: PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Slovenian: Pri zdravljenju z eritropoetinom, vključno z zdravilom NeoRecormon, so poročali o čisti aplaziji rdečih krvnih celic, ki jo povzročajo nevtralizirajoča protitelesa proti eritropoetinu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/032
English: NeoRecormon dosing
Slovenian: Odmerjanje zdravila NeoRecormon
English: 6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
Slovenian: 6 napolnjenih injekcijskih brizg (0,6 ml) in 6 injekcijskih igel (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 5000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 3000 i.e. epoetina beta.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 10.000 i.e. napolnjena injekcijska brizga
English: 1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2)
Slovenian: 1 napolnjena injekcijska brizga (0,6 ml) in 1 injekcijska igla (27G1/2)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 500 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 500 i.e. epoetina beta.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 3000 i.e. napolnjena injekcijska brizga
English: The dosage may be raised after 4 weeks to 80 IU/kg - three times per week - and by further increments of 20 IU/kg if needed, three times per week, at monthly intervals.
Slovenian: Če je treba odmerek še povečati, ga povečujemo po 20 i.e./kg telesne mase 3-krat tedensko z enomesečnimi presledki.
English: Medicinal product contains phenylalanine and sodium, see leaflet for further information
Slovenian: Zdravilo vsebuje fenilalanin in natrij.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 30,000 IU injection epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE NeoRecormon 30.000 i.e. injekcija epoetin beta i.v./s.c.
English: (5) Attach the device to the vial until the snap lock clicks home. (6) Put the green needle on the syringe contained in the package and remove the needle cover.
Slovenian: (6) Zeleno iglo pritrdite na brizgo, ki je priložena v ovojnini in odstranite igelno zaščito.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 10.000 i.e. epoetina beta.
English: · Take the carton with the syringe(s) and needle(s) out of the refrigerator
Slovenian: • Injekcijsko brizgo lahko vzamete iz hladilnika in jo nato hranite pri sobni temperaturi (do
English: This may be given as one injection per week, or in divided doses as 3 to 7 injections per week.
Slovenian: Začetni tedenski odmerek je 30.000 i.e. Lahko ga damo kot eno injekcijo na teden ali v razdeljenih odmerkih 3 do 7 injekcij na teden.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta
Slovenian: NeoRecormon 4000 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin beta
English: ·Do not touch the injection site again before giving the injection.
Slovenian: • Že uporabljene injekcijske brizge ne uporabljajte ponovno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 napolnjena injekcijska brizga vsebuje 4000 i.e. epoetina beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/97/031/038