FrancophonIA/ELRC3.0 huggingface dataset:
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).
Icelandic: Ein áfyllt sprauta með 0,6 ml af stungulyfi, lausn inniheldur 30.000 alþjóðlegar einingar (a.e.) sem jafngilda 250 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine,
Icelandic: Natríumklóríð, Pólýsorbat 20, Natríumtvíhýdrógenfosfat, Tvínatríumhýdrógenfosfat, Kalsíumklóríð, Glýsín,
English: · Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðútbrot, þ.m.t. StevensJohnson heilkenni og eitrunardreplos í húðþekju.
English: - Subcutaneous administration:
Icelandic: Frostþurrkað efni:
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).
Icelandic: Ein áfyllt sprauta með 0,6 ml af stungulyfi, lausn inniheldur 20.000 alþjóðlegar einingar (a.e.) sem jafngilda 166 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: What you need to know before you use NeoRecormon
Icelandic: Leitið ráða hjá lækninum áður en NeoRecormon er notað
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).
Icelandic: Ein áfyllt sprauta með 0,3 ml af stungulyfi, lausn inniheldur 6000 alþjóðlegar einingar (a.e.) sem jafngilda 49,8 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: Serious skin reaction including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðviðbrögð, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju.
English: · Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy · Treating people donating their own blood before surgery.
Icelandic: - að meðhöndla einkennabundið blóðleysi hjá fullorðnum sjúklingum með illkynja sjúkdóma í öðrum frumum en mergfrumum og fá krabbameinslyfjameðferð. - að auka afrakstur eigin blóðgjafar hjá sjúklingum fyrir síðari eigin blóðgjöf.
English: The maximum dose should not exceed · for injections into veins: 1600 IU for every 1 kg of your body weight per week · for injections under the skin: 1200 IU for every 1 kg of your body weight per week.
Icelandic: 1600 a.e. á hvert kg líkamsþyngdar á viku innspýtingar undir húð:
English: 14 Adjust to your prescribed dose by slowly pushing the plunger.
Icelandic: 14 Stillið sprautuna á þann skammt sem ávísað var með því að þrýsta hægt á stimpilstöngina.
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).
Icelandic: Ein áfyllt sprauta með 0,3 ml af stungulyfi, lausn inniheldur 3000 alþjóðlegar einingar (a.e.) sem jafngilda 24,9 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially “sodium-free”.
Icelandic: Lyfið inniheldur minna en 1 mmól af natríum (23 mg) í hverjum skammti, þ.e. er nánast natríumsnautt.
English: NeoRecormon therapy is started by a doctor who is an expert on your condition.
Icelandic: Læknir sem er sérfræðingur í þínum sjúkdómi á að hefja meðferð með NeoRecormon.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Icelandic: Fjórar af rannsóknununum voru tvíblindar samanburðarrannsóknir með lyfleysu og ein var opin rannsókn.
English: · Do not push or pull the plunger.
Icelandic: Ekki ýta á eða toga í stimpilstöngina.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR 30.000 IU áfyllt sprauta
English: If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Icelandic: Gera skal lækninum samstundis viðvart ef fram koma óeðlileg soghljóð eða öndunarerfiðleikar; bólga í tungu, andliti eða hálsi eða þroti við stungustað; sundl, yfirlið eða örmögnun.
English: · Keep the syringe and needle and the puncture-resistant or sharps disposal container out of reach of children.
Icelandic: Geymið sprautur, nálar og nálarhelt ílát undir notaðar sprautunálar (nálabox) þar sem börn hvorki ná til né sjá.
English: INFORMATION IN BRAILLE neorecormon 30.000 IU
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI neorecormon 30.000 IU
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).
Icelandic: Ein áfyllt sprauta með 0,3 ml af stungulyfi, lausn inniheldur 2000 alþjóðlegar einingar (a.e.) sem jafngilda 16,6 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: Fertility
Icelandic: Margnota
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta.
Icelandic: VIRK(T) EFNI 1 áfyllt sprauta inniheldur 30.000 IU epóetín beta.
English: · Keep your syringe out of direct sunlight.
Icelandic: Ekki geyma sprauturnar í beinu sólarljósi.
English: · Do not recap the injection needle with the cap. · Do not throw away (dispose of) the syringe in your household trash.
Icelandic: Ekki farga sprautunni með heimilissorpi.
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).
Icelandic: Ein áfyllt sprauta með 0,3 ml af stungulyfi, lausn inniheldur 500 alþjóðlegar einingar (a.e.) sem jafngilda 4,15 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: 1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2)
Icelandic: 1 áfyllt sprauta (0,3 ml) og 1 nál (27G1/2)
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR 4000 IU áfyllt sprauta
English: · People donating their own blood before surgery Injections are given into a vein over two minutes, or under the skin.
Icelandic: Innspýtingar eru gefnar í bláæð á tveimur mínútum eða undir húð.
English: 4 Inspect the syringe and needle closely · Check the syringe and needle for any damage.
Icelandic: 4 Skoðið sprautuna og nálina vandlega
English: INFORMATION IN BRAILLE neorecormon 4000 IU
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI neorecormon 4000 IU
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 12 -14 g/dl.
Icelandic: tveimur rannsóknum var miðað við að ná blóðrauðastyrk > 13 g/dl; í hinum þremur rannsóknunum var markgildi 12-14 g/dl. Í opnu rannsókninni sást enginn munur á heildarlifun milli sjúklinga sem meðhöndlaðir voru með raðbrigða erýtrópóíetíni úr mönnum og viðmiðunarhóps.
English: The reconstituted product is a colourless, clear to slightly opalescent solution.
Icelandic: Blandað lyfið er litlaus, tær eða hálf gegnsæ lausn.
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).
Icelandic: Ein áfyllt sprauta með 0,3 ml af stungulyfi, lausn inniheldur 4000 alþjóðlegar einingar (a.e.) sem jafngilda 33,2 míkrógrömmum af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: Keep the pre-filled syringe in the outer carton, in order to protect from light
Icelandic: Geymið áfylltu sprautuna í ytri umbúðum til varnar gegn ljósi
English: 4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
Icelandic: 4 áfylltar sprautur (0,6 ml) og 4 nálar (27G1/2)
English: Roche România S.R.L.
Icelandic: Česká republika Roche s. r. o.
English: 1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2)
Icelandic: 1 áfyllt sprauta (0,6 ml) og 1 nál (27G1/2)
English: One ml solution for injection contains 10,000 IU epoetin beta.
Icelandic: Einn ml af stungulyfi inniheldur 10.000 a.e. af epóetín beta.
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).
Icelandic: Ein áfyllt sprauta með 0,6 ml af stungulyfi, lausn inniheldur 10.000 alþjóðlegar einingar (a.e.) sem jafngilda 83 míkrógrömm af epóetín beta* (raðbrigða erýtrópóíetíni í mönnum).
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR 2000 IU áfyllt sprauta
English: INFORMATION IN BRAILLE neorecormon 3000 IU
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI neorecormon 3000 IU
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4)
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðviðbrögð (SCARs), sem geta verið lífshættuleg eða banvæn, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju (sjá kafla
English: NeoRecormon 500 IU solution for injection in pre-filled syringe
Icelandic: NeoRecormon 500 a.e. stungulyf, lausn í áfylltri sprautu
English: Anaemic patients with chronic renal failure
Icelandic: Viðbótar aukaverkanir hjá sjúklingum með langvinna nýrnabilun (nýrnablóðleysi)
English: Urea,
Icelandic: Þvagefni,
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta.
Icelandic: VIRK(T) EFNI 1 áfyllt sprauta inniheldur 4000 IU epóetín beta.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR 10.000 IU áfyllt sprauta
English: 6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
Icelandic: 6 áfylltar sprautur (0,3 ml) og 6 nálar (27G1/2)
English: Correction phase
Icelandic: Leiðréttingarmeðferð
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection
Icelandic: HEITI LYFS NeoRecormon margnota 50 000 a.e. frostþurrkað stungulyf og leysir, lausn
English: Keep pressing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
Icelandic: Þrýstið þar til það magn af NeoRecormon er eftir í sprautunni sem mælt er fyrir um.
English: If signs and symptoms suggestive of these reactions appear, NeoRecormon should be withdrawn immediately and an alternative treatement considered.If the patient has developed a severe cutaneous skin reaction such as SJS orTEN due to the use of NeoRecormon, treatment with ESA must not be restarted in this patient at any time.
Icelandic: Hafi sjúklingurinn fengið alvarleg húðviðbrögð svo sem Stevens-Johnson heilkenni eða eitrunardreplos í húðþekju vegna notkunar NeoRecormon má aldrei aftur hefja meðferð með lyfjum sem örva rauðkornamyndun (ESA-lyfjum) hjá þeim sjúklingi.
English: · People donating their own blood before surgery Injections are given into a vein over 2 minutes, or under the skin.
Icelandic: Innspýtingar eru gefnar í bláæð á 2 mínútum eða undir húð.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 50,000 IU epoetin beta.
Icelandic: VIRK(T) EFNI 1 hettuglas inniheldur 50.000 IU epóetín beta.
English: NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: Each pre-filled syringe contains 0.3 ml solution.
Icelandic: NeoRecormon 500 a.e., 2000 a.e., 3000 a.e., 4000 a.e., 5000 a.e. og 6000 a.e.:
English: Female patients
Icelandic: Konur
English: Additional side effects in adults receiving chemotherapy for cancer · Increase in blood pressure and headache may occasionally occur.
Icelandic: Blóðþrýstingshækkun og höfuðverkur geta einstöku sinnum átt sér stað.
English: You can press a dry sterile pad over the injection site.
Icelandic: Hægt er að þrýsta þurri, dauðhreinsaðri grisju á stungustaðinn.
English: Do not use the syringe if you have dropped the syringe or if any part of the syringe appears to be damaged.
Icelandic: Ekki nota sprautuna ef hún hefur dottið eða ef einhver hluti hennar virðist skemmdur.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Icelandic: B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN Ávísun lyfsins er háð sérstökum takmörkunum (sjá viðauka 1:
English: In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Icelandic: Hjartadrep eða heilablæðing í mánuðinum fyrir meðferð, hvikul hjartaöng, aukin hætta á segamyndun í djúplægri bláæð, til dæmis saga um segarek í bláæðum.
English: White lyophilisate and clear, colourless solvent.
Icelandic: Hvítt frostþurrkað duft og tær, litlaus lausn.
English: The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w.
Icelandic: Gjöf undir húð með skammti sem nemur 3 x 250 a.e./kg líkamsþunga á viku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta.
Icelandic: VIRK(T) EFNI 1 áfyllt sprauta inniheldur 3000 IU epóetín beta.
English: Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Icelandic: Dragið nálina hratt út og þrýstið samtímis sprittþurrku yfir stungustað.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe
Icelandic: LÁGMARKS UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI UMBÚÐIR 3000 IU áfyllt sprauta
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.
Icelandic: Hægt er að gefa NeoRecormon á tvo vegu og læknirinn mun ákveða hvor þeirra hentar þér:
English: 6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
Icelandic: 6 áfylltar sprautur (0,6 ml) og 6 nálar (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 500 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: · in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative
Icelandic: • er í hættu á blóðtappa í bláæðum (segamyndun í djúplægri bláæð), t.d. ef áður hefur verið um blóðtappa að ræða hjá ungabörnum eða ungum börnum að þriggja ára aldri, þar sem margnota NeoRecormon leysir inniheldur benzýl alkóhól sem rotvarnarefni.
English: Take hold of the stem and snap off away from you.
Icelandic: Tekið er um hálsinn og brotið í áttina frá þér.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 20.000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: Chronic renal failure
Icelandic: Langvinn nýrnabilun
English: NeoRecormon is a solution in a pre-filled syringe for injection The solution is colourless, clear to slightly opalescent.
Icelandic: NeoRecormon margnota er frostþurrkað stungulyf og leysir, lausn.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection Epoetin beta
Icelandic: NeoRecormon margnota 50.000 IU frostþurrkað stungulyf og leysir, lausn epóetín beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/032
English: Hypertension Hypertensive crisis
Icelandic: Lífshættulegur háþrýstingur
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 5000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Icelandic: Epóetín eru vaxtarþættir sem örva aðallega myndun rauðra blóðkorna.
English: Blood and the lymphatic system disorders
Icelandic: Einkennabundið blóðleysi af völdum langvinns nýrnasjúkdóms
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta.
Icelandic: VIRK(T) EFNI 1 áfyllt sprauta inniheldur 10.000 IU epóetín beta.
English: 1 vial contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
Icelandic: Þvagefni, natríumklóríð, pólýsorbat 20, natríumtvíhýdrógenfosfat, tvínatríumhýdrógenfosfat, kalsíumklóríð, glýsín, L-Leucín, L-Ísóleucín, L-Treónín, L-Glútamínsýru og L-Fenýlalanín.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 30.000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 4000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/046
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/043
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 2000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 2000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection.
Icelandic: LYFJAFORM OG INNIHALD Stungulyf, lausn
English: NeoRecormon 30,000 IU solution for injection in pre-filled syringe
Icelandic: NeoRecormon 30.000 a.e. stungulyf, lausn í áfylltri sprautu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/038
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.
Icelandic: Þvagefni, natríumklóríð, pólýsorbat 20, natríumtvíhýdrógenfosfattvíhýdrat, tvínatríumfosfatdódekahýdrat, kalsíumklóríðtvíhýdrat, glýsín, L-Leucín, L-Ísóleucín, L-Treónín, LGlútamínsýr, L-Fenýlalanín og vatn fyrir stungulyf.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 2000 IU injection epoetin beta
Icelandic: NeoRecormon 2000 IU stungulyf epóetín beta i.v./s.c. notkun
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/025
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/025
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 6000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: ·Do not fan or blow on the cleaned area.
Icelandic: Ekki beina lofti að hreinsaða svæðinu eða blása á það.
English: In the lyophilisate: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium chloride, glycine, L-Leucine, L-Isoleucine, LThreonine, L-Glutamic acid, and L-Phenylalanine.
Icelandic: Í frostþurrkaða efninu þvagefni, natríumklóríð, pólýsorbat 20, natríumtvíhýdrógenfosfat, tvínatríumhýdrógenfosfat, kalsíumklóríð, glýsín, L-Leucín, L-Ísóleucín, L-Treónín, LGlútamínsýra og L-Fenýlalanín.
English: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in CKD patients System organ class
Icelandic: Aukaverkanir sem taldar eru stafa af meðferð með NeoRecormon í klínískum samanburðarrannsóknum hjá sjúklingum með langvinnan nýrnasjúkdóm.
English: - Intravenous administration:
Icelandic: • innspýtingar í bláæðar:
English: · The other ingredients are: 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, and L-Phenylalanine and water for injections.
Icelandic: Önnur innihaldsefni eru þvagefni, natríumklóríð, pólýsorbat 20, natríumtvíhýdrógenfosfattvíhýdrat, tvínatríumfosfatdódekahýdrat, kalsíumklóríðtvíhýdrat, glýsín, L-Leucín, L-Ísóleucín, L-Treónín, L-Glútamínsýra, L-Fenýlalanín og vatn fyrir stungulyf.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/029
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/042
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/026
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/026
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/044
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/044
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/033
English: Additional side effects in people donating their own blood before surgery · A slight increase in the occurrence of blood clots has been observed.
Icelandic: Viðbótar aukaverkanir hjá fólki sem gefur eigið blóð fyrir skurðaðgerð •
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/037
English: · Adults with symptomatic anaemia receiving chemotherapy for cancer Injections are given under the skin.
Icelandic: • að meðhöndla blóðleysi ásamt tengdum einkennum hjá fullorðnum krabbameinssjúklingum sem fá krabbameinslyfjameðferð.
English: Inject NeoRecormon solution.
Icelandic: Við meðferð með NeoRecormon
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
Icelandic: NeoRecormon 500 a.e. NeoRecormon 2000 a.e. NeoRecormon 3000 a.e. NeoRecormon 4000 a.e. NeoRecormon 5000 a.e. NeoRecormon 6000 a.e. NeoRecormon 10.000 a.e. NeoRecormon 20.000 a.e. NeoRecormon 30.000 a.e. stungulyf, lausn í áfylltri sprautu
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS/AMPOULE
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/045
English: Depending on your individual situation a blood transfusion may be preferable.
Icelandic: Æskilegra getur verið að nota blóðgjöf en það er háð einstaklingsbundnu ástandi.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta
Icelandic: NeoRecormon 3000 IU stungulyf, lausn í áfylltri sprautu epóetín beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/031/035