FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine if you notice the pre-filled syringe contents are cloudy or there are particles in it.
Icelandic: Ekki skal nota lyfið ef innihald áfylltu sprautunnar er skýjað eða ef í því eru agnir.
English: Syringe safety guard
Icelandic: Yfirlit yfir öryggi
English: After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
Icelandic: Hverju sinni sem skammti eða skömmtunaráætlun er breytt á að mæla blóðrauða á einnar eða tveggja vikna fresti.
English: Aranesp may be administered subcutaneously by the patient or a carer after being trained by a doctor, nurse or pharmacist.
Icelandic: Aranesp undir húð eftir að hafa fengið þjálfun hjá lækni, hjúkrunarfræðingi eða lyfjafræðingi.
English: In patients with a poor haemoglobin response to Aranesp, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Icelandic: Íhuga skal aðrar skýringar á lélegri svörun hjá sjúklingum með lélega blóðrauðasvörun við Aranesp (sjá kafla 4.4. og 5.1)
English: Solution for injection (injection) in vial.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
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.
Icelandic: Greint hefur verið frá alvarlegum aukaverkunum á húð í tengslum við meðferð með epóetíni, sem geta verið lífshættulegar eða banvænar, þ.m.t. Stevens-Johnson-heilkenni og eitrunardrep í húðþekju (toxic epidermal necrolysis).
English: Serum potassium levels should be monitored regularly during Aranesp therapy.
Icelandic: Fylgjast á reglulega með magni kalíums í sermi þann tíma sem Aranesp meðferð varir.
English: Uncommon1
Icelandic: Sjaldgæfar1
English: Put the used pre-filled pen in the sharps disposal container immediately after use.
Icelandic: Setjið áfyllta pennann í nálabox strax að notkun lokinni.
English: INFORMATION IN BRAILLE Aranesp 20 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 20 sprauta
English: INFORMATION IN BRAILLE Aranesp 10 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 10 sprauta
English: Aranesp is available in packs of 1 or 4 vials.
Icelandic: Aranesp er fáanlegt í pakkningum með 1 eða 4 hettuglösum.
English: The pre-filled pen contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
Icelandic: Áfyllti penninn inniheldur 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 eða 500 míkrógrömm af darbepoetin alfa.
English: INFORMATION IN BRAILLE Aranesp 130 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 130 sprauta
English: In a clinical study in 124 paediatric patients with chronic kidney disease receiving or not receiving dialysis aged 1 to 18, patients that were stable on epoetin alfa were randomised to receive either darbepoetin alfa administered once weekly (subcutaneously or intravenously) using a dose conversion ratio of 238:1 or to continue with epoetin alfa therapy at the current dose, schedule, and route of administration.
Icelandic: Í klínískri rannsókn hjá 124 börnum á aldrinum 1 til 18 ára með langvinnan nýrnasjúkdóm sem voru eða voru ekki í blóðskilun, var sjúklingum sem voru í jafnvægi á epóetín alfa slembiraðað til að fá annaðhvort darbepoetin alfa einu sinni í viku (s.c. eða i.v.) með skammtaaðlögunarhlutfallinu
English: You should contact your doctor, nurse or pharmacist if this does happen.
Icelandic: Í slíkum tilvikum skal hafa samband við lækninn, hjúkrunarfræðing eða lyfjafræðing.
English: If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by approximately 25%.
Icelandic: Ef blóðrauði eykst um meira en 2 g/dl (1,25 mmól/l) á 4 vikum skal minnka skammtinn um 25 til
English: Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood.
Icelandic: Fjöldi rauðra blóðkorna í blóðinu getur haft áhrif á verkun lyfjanna ciklosporin og tacrolimus (lyf sem bæla ónæmiskerfið).
English: Aranesp is a clear, colourless or slightly pearly solution for injection in vial.
Icelandic: Aranesp er tær, litlaus eða lítillega perluhvít lausn fyrir stungulyf í hettuglasi.
English: Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled pen.
Icelandic: Aranesp er tær, litlaus eða lítillega perluhvít lausn í áfylltum penna.
English: b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in evolution.
Icelandic: b Heilablóðfall nær til kjörheitanna blæðingarslag, blóðþurrðarslag, heilablóðfall og yfirstandandi slag.
English: If the increase in haemoglobin is inadequate (less than 1 g/dL (0.6 mmol/L) in four weeks) increase the dose by approximately 25%.
Icelandic: Ef ekki næst nægilega mikil aukning á blóðrauða (minna en 1 g/dl (0,6 mmól/l) á fjórum vikum) skal auka skammtinn um því sem næst 25%.
English: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Icelandic: Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 míkrógrömm stungulyf, lausn í áfylltri sprautu
English: Disposing of used syringes
Icelandic: Aranesp með áfylltu sprautunni
English: INFORMATION IN BRAILLE Aranesp 30 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 30 sprauta
English: INFORMATION IN BRAILLE Aranesp 50 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 50 sprauta
English: • Blood clots (thrombosis)
Icelandic: Förgunarlát fyrir nálar (nálabox)
English: Before administration the Aranesp solution should be inspected for visible particles.
Icelandic: Áður en Aranesp lausnin er notuð verður að skyggna hana með tilliti til sýnilegra agna.
English: In order to correct your anaemia, your initial dose will be
Icelandic: Til að vinna bug á blóðleysinu er upphafsskammtur Aranesp:
English: HR 1.05, 95% CI (0.94, 1.17)), or all-cause mortality or end stage renal disease (ESRD) (darbepoetin alfa vs placebo; HR 1.06, 95% CI (0.95, 1.19)).
Icelandic: Rannsóknin náði hvorugu aðalmarkmiðinu sem var annars vegar að sýna fram á fækkun dauðsfalla af hvaða orsök sem er, fækkun sjúkdómstilvika sem tengjast hjarta og æðum (darebepoetin alfa samanborið við lyfleysu, áhættuhlutfall 1,05, 95% öryggisbil (0,94; 1,17)) og hins vegar fækkun dauðsfalla af hvaða orsök sem er eða nýrnasjúkdómi á lokastigi (darbepoetin alfa samanborið við lyfleysu; áhættuhlutfall 1,06, 95% öryggisbil (0,95; 1,19)).
English: Aranesp is available in packs of 1 or 4 pre-filled syringes.
Icelandic: Aranesp er fáanlegt í pakkningum með 1 eða 4 áfylltum sprautum.
English: INFORMATION IN BRAILLE Aranesp 80 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 80 penni
English: In controlled clinical studies, use of Aranesp and other ESAs have shown:
Icelandic: Notkun Aranesp og annarra rauðkornavaka í klínískum samanburðarrannsóknum hafa sýnt:
English: Injection site paine
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
Icelandic: Helmingunartími var einnig svipaður hjá fullorðnum og börnum með langvarandi nýrnabilun bæði eftir gjöf í bláæð og undir húð.
English: INFORMATION IN BRAILLE Aranesp 100 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 100 sprauta
English: EU/1/01/185/111 4 Pack
Icelandic: EU/1/01/185/111 4 hettuglös
English: INFORMATION IN BRAILLE Aranesp 60 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 60 penni
English: INFORMATION IN BRAILLE Aranesp 500 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 500 penni
English: • Cotton ball or gauze pad
Icelandic: Bómullarhnoðra eða grisju
English: This has been predominantly reported in patients with CRF treated subcutaneously.
Icelandic: Aðallega hefur verið greint frá þessu hjá sjúklingum með langvarandi nýrnabilun sem fá meðferð með lyfjagjöf undir húð.
English: INFORMATION IN BRAILLE Aranesp 130 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 130 penni
English: INFORMATION IN BRAILLE Aranesp 80 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 80 sprauta
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Icelandic: Geymið áfyllta pennann í ytri umbúðum til varnar gegn ljósi.
English: INFORMATION IN BRAILLE Aranesp 20 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 20 penni
English: - Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Icelandic: - Gæta skal sérstakrar varúðar við notkun annarra lyfja sem örva myndun rauðra blóðkorna:
English: 1 single use pre-filled syringe.
Icelandic: 1 einnota áfyllt sprauta.
English: IV/SC 0.375 ml
Icelandic: 0,375 ml
English: The initial weekly paediatric dose of Aranesp (mcg/week) can be determined by dividing the total weekly dose of r-HuEPO (IU/week) by 240.
Icelandic: Upphafsskammt Aranesp fyrir börn sem gefinn er vikulega (μg/viku) má ákvarða með því að deila með 240 í heildar vikuskammt r-HuEPO (a.e./viku).
English: In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
Icelandic: Hjá krabbameinssjúklingum sem fá krabbameinslyfjameðferð eru orsakir blóðleysis margþættar.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON WITHOUT TRAY
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ ÁFYLLTRI SPRAUTU ÁN BAKKA
English: The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Icelandic: Í slembaðri, tvíblindri, fjölþjóðlegri rannsókn var lagt mat á öryggi og verkun þess að gefa Aranesp á þriggja vikna fresti til að draga úr þörf á að gefa sjúklingum í krabbameinslyfjameðferð rauð blóðkorn.
English: INFORMATION IN BRAILLE Aranesp 50 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 50 penni
English: Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and
Icelandic: M.a. slembiraðaðar, tvíblindar rannsóknir með virkum samanburði (970200, 970235, 980117, 980202 og 980211) nema fyrir aukaverkunina heilablóðfall sem litið var á sem aukaverkun í TREAT rannsókninni (rannsókn 20010184).
English: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dL (8.7 mmol/L), ESAs are not indicated for use in this patient population.
Icelandic: á ný hjá sjúklingum með langt gengið krabbamein í höfði eða hálsi, sem voru í geislameðferð, þegar leitast var við að ná blóðrauðagildi sem hærra en 14 g/dl (8,7 mmól/l).
English: INFORMATION IN BRAILLE Aranesp 60 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 60 sprauta
English: Aranesp 40 micrograms solution for injection vial EU/1/01/185/102 1 Pack
Icelandic: Aranesp 40 míkrógrömm stungulyf, lausn í hettuglasi EU/1/01/185/102 1 hettuglas
English: Treatment of symptomatic chemotherapy-induced anaemia in cancer patients
Icelandic: Meðferð við blóðleysi með einkennum eftir lyfjameðferð, hjá krabbameinssjúklingum
English: The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
Icelandic: Áfyllta sprautan inniheldur 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 eða 500 míkrógrömm af darbepoetin alfa.
English: INFORMATION IN BRAILLE Aranesp 30 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 30 penni
English: Do not remove the grey cap from the pre-filled pen until you are ready to inject.
Icelandic: Ekki taka gráu nálarhlífina af áfyllta pennanum fyrr en allt er tilbúið til inndælingar.
English: INFORMATION IN BRAILLE Aranesp 15 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 15 sprauta
English: INFORMATION IN BRAILLE Aranesp 150 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 150 sprauta
English: For paediatric patients ≥ 1 year of age, in the maintenance phase, Aranesp may continue to be administered as a single injection once weekly or once every two weeks.
Icelandic: Fyrir börn ≥ 1 árs, má í viðhaldsfasa halda áfram að gefa Aranesp með einni inndælingu vikulega eða á tveggja vikna fresti.
English: INFORMATION IN BRAILLE Aranesp 40 syringe
Icelandic: MEÐ BLINDRALETRI Aranesp 40 sprauta
English: INFORMATION IN BRAILLE Aranesp 300 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 300 penni
English: Do not use this medicine if you notice the pre-filled pen contents are cloudy or there are particles in it.
Icelandic: Ekki skal nota lyfið ef innihald pennans er skýjað eða ef í því eru agnir.
English: The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 240.
Icelandic: Hægt er að ákvarða upphafsskammt Aranesp sem gefinn er aðra hverja viku (μg/aðra hverja viku) með því að deila með 240 í heildarskammt af r-HuEPO sem gefinn er á tveggja vikna tímabili.
English: Pack size of 1 or 4 vials.
Icelandic: Pakkningar með einu eða fjórum hettuglösum.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 80 µg injection
Icelandic: Aranesp 80 µg stungulyf
English: If the rise in haemoglobin is greater than 2 g/dL (1.25 mmol/L) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
Icelandic: Ef blóðrauði eykst um meira en 2 g/dl (1,25 mmól/l) á fjórum vikum skal minnka skammtinn um u.þ.b. 25%, háð því hve hröð aukningin er.
English: INFORMATION IN BRAILLE Aranesp 100 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 100 penni
English: Stretch method
Icelandic: Notaður stimpill
English: INFORMATION IN BRAILLE Aranesp 40 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 40 penni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 15 µg injection
Icelandic: Aranesp 15 µg stungulyf
English: Do not use the pre-filled pen if the expiry date printed after EXP on the label has passed.
Icelandic: Notið ekki áfyllta pennann ef komið er fram yfir fyrningardagsetningu á merkimiða.
English: When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Icelandic: Þegar hettuglasið hefur verið tekið úr kæli og staðið við stofuhita í um það bil 30 mínútur fyrir notkun, verður annaðhvort að nota það innan 7 daga eða farga því.
English: Pharmacotherapeutic group: Anti-anaemic preparations, other anti-anaemic preparations, ATC Code: B03XA02.
Icelandic: Blóðleysislyf, önnur blóðleysislyf, ATC flokkur:
English: Aranesp 25 micrograms solution for injection in vial Each vial contains 25 micrograms of darbepoetin alfa in 1 mL (25 mcg/mL).
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi Hvert hettuglas inniheldur 25 míkrógrömm darbepoetin alfa í 1 ml (25 μg/ml).
English: b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues.
Icelandic: c Aukaverkunin útbrot nær til kjörheitanna útbrot, kláðaútbrot, útbreidd útbrot, dröfnuútbrot, roðaþot, flagnandi útbrot, dröfnuörðuútbrot, vessablöðruútbrot svo og graftarbóluútbrot undir líffæraflokknum Sýkingar af völdum sýkla og sníkjudýra.
English: Do not use any Aranesp that is left in the syringe.
Icelandic: Aranesp sem kann að verða eftir í sprautunni má ekki nota síðar.
English: When your pen has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Icelandic: Þegar búið er að taka Aranesp pennann úr kæli og hann hefur staðið við stofuhita í um það bil 30 mínútur fyrir notkun, verður annaðhvort að nota hann innan 7 daga eða farga honum.
English: Do not remove the cap from the syringe until you are ready to inject.
Icelandic: Fjarlægið ekki hlífina af sprautunni fyrr en komið er að inndælingu.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 300 µg injection
Icelandic: Aranesp 300 µg stungulyf
English: NAME OF THE MEDICINAL PRODUCT Aranesp 100 µg injection
Icelandic: Aranesp 100 µg stungulyf
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
Icelandic: Greint hefur verið frá rauðkornskímfrumnafæð (pure red cell aplasia) af völdum hlutleysandi and-erýtrópóetín mótefna, í tengslum við rauðkornavaka, þ.m.t. Aranesp.
English: Allow the container to reach room temperature before injecting.
Icelandic: Leyfið lyfinu að ná stofuhita fyrir dælingu.
English: INFORMATION IN BRAILLE Aranesp 10 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 10 penni
English: Stroke was reported as common in CRF patients in TREAT (see section 5.1).
Icelandic: Greint var frá heilablóðfalli sem algengri aukaverkun hjá sjúklingum með langvinna nýrnabilun í TREAT (sjá kafla 5.1).
English: Not known: frequency cannot be estimated from available data • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Icelandic: Rauðkornskímfrumnafæð - (blóðleysi, óvenjuleg þreyta, þróttleysi)
English: Injection site pain
Icelandic: Merkimiði á sprautu
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 mL vial contains 60 micrograms darbepoetin alfa.
Icelandic: VIRK(T) EFNI Hvert 1 ml hettuglas inniheldur 60 míkrógrömm darbepoetin alfa.
English: Please tell your doctor if you are suffering or have suffered from: - high blood pressure which is being controlled with medicines prescribed by your doctor; - sickle cell anaemia; - epileptic fits (seizures); - convulsions (fits or seizures); - liver disease; - significant lack of response to medicines used to treat anaemia; - an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or - hepatitis C.
Icelandic: - háan blóðþrýsting sem náðst hefur stjórn á með öðrum lyfjum sem læknirinn hefur ávísað, - sigðkornablóðleysi, - flogaköst, - krampa, - lifrarsjúkdóm, - ófullnægjandi svörun við lyfjum sem notuð eru við blóðleysi, - ofnæmi fyrir latexi (nálarhlífin á áfyllta pennanum inniheldur latexafleiðu) eða - lifrarbólgu C.
English: Aranesp should be used with caution in patients with epilepsy.
Icelandic: Gæta skal varúðar við notkun Aranesp hjá sjúklingum með flogaveiki.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 0.375 mL pre-filled pen contains 15 micrograms darbepoetin alfa (40 micrograms/mL).
Icelandic: VIRK(T) EFNI Hver 0,375 ml áfylltur penni inniheldur 15 míkrógrömm darbepoetin alfa (40 míkrógrömm/ml).
English: The median TTP based on IRCdetermined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI: 0.924, 1.156).
Icelandic: Miðgildi tímalengdar fram að versnun sjúkdóms (TTP) byggt á skilgreiningu rannsóknaraðila á framgangi sjúkdóms (PD) var 8,0 mánuðir í hópnum sem fékk epoetin alfa ásamt hefðbundinni meðferð og 8,3 mánuðir í hópnum sem fékk hefðbundna meðferð (HR 1,033; 95% CI:
English: EU/1/01/185/107 4 pack
Icelandic: EU/1/01/185/107 4 hettuglös
English: Hypertension
Icelandic: Ofnæmia
English: The initial every other week dose of Aranesp (mcg/every other week) can be determined by dividing the total cumulative dose of r-HuEPO administered over a two-week period by 200.
Icelandic: Aranesp sem gefinn er aðra hverja viku (μg/aðra hverja viku) má ákvarða með því að deila með 200 í þann heildarskammt r-HuEPO sem gefinn er á tveimur vikum.
English: In CRF patients on haemodialysis, events of vascular access thrombosis (such as vascular access complication, arteriovenous fistula thrombosis, graft thrombosis, shunt thrombosis, arteriovenous fistula site complication, etc.) have been reported in post-marketing data.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun sem eru í blóðskilun hefur verið tilkynnt um tilvik blóðtappamyndunar við æðaaðgengi (eins og fylgikvillar við æðaaðgengi, fistilsegarek í slag- eða bláæð, græðlingssegarek, samveitusegarek, fylgikvillar æðafistils, o.s.frv.) eftir markaðssetningu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/071
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/071
English: Aranesp 130 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 130 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 130 micrograms solution for injection in pre-filled pen Darbepoetin alfa
Icelandic: Aranesp 130 míkrógrömm stungulyf, lausn í áfylltum penna Darbepoetin alfa
English: NAME OF THE MEDICINAL PRODUCT Aranesp 150 µg injection
Icelandic: Aranesp 150 µg stungulyf
English: • Keep the pre-filled pen in the outer carton in order to protect from light or physical damage.
Icelandic: Geymið áfyllta pennann í ytri umbúðum til varnar gegn ljósi og skemmdum.
English: Convulsions
Icelandic: Háþrýstingur
English: NAME OF THE MEDICINAL PRODUCT Aranesp 40 µg injection
Icelandic: Aranesp 40 µg stungulyf
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ PENNA
English: Aranesp in a pre-filled pen is only for subcutaneous administration.
Icelandic: Aranesp í áfylltum penna má aðeins gefa undir húð.
English: Instructions for use: Guide to parts
Icelandic: Leiðbeiningar um notkun:
English: Aranesp 500 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 500 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: INFORMATION IN BRAILLE Aranesp 150 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 150 penni
English: I When you are ready to inject, pressthe red start button.
Icelandic: I Ýtið á rauða starthnappinn þegar þú ert tilbúin(n) fyrir inndælingu.
English: • Shortness of breath (allergic bronchospasm)
Icelandic: Andþrengsli (ofnæmisberkjukrampi)
English: PHARMACEUTICAL FORM AND CONTENTS 1 single use vial
Icelandic: LYFJAFORM OG INNIHALD 1 einnota hettuglas
English: Oedemad
Icelandic: Geymsla
English: INFORMATION IN BRAILLE Aranesp 15 pen
Icelandic: MEÐ BLINDRALETRI Aranesp 15 penni
English: NAME OF THE MEDICINAL PRODUCT Aranesp 130 µg injection
Icelandic: Aranesp 130 µg stungulyf
English: Aranesp is supplied ready for use in a pre-filled syringe.
Icelandic: Aranesp er í áfylltum sprautum sem eru tilbúnar til notkunar.
English: NAME OF THE MEDICINAL PRODUCT Aranesp 20 µg injection
Icelandic: Aranesp 20 µg stungulyf
English: Aranesp 25 micrograms solution for injection in vial.
Icelandic: Aranesp 25 míkrógrömm stungulyf, lausn í hettuglasi.
English: EU/1/01/185/109 4 pack
Icelandic: EU/1/01/185/109 4 hettuglös
English: PRE-FILLED SYRINGE LABEL WHEN USED WITHOUT TRAY
Icelandic: MERKIMIÐI ÁFYLLTRAR SPRAUTU ÞEGAR
English: Step 3: Inject G Hold the stretch or pinch.
Icelandic: G Haldið áfram að teygja eða klípa.
English: Aranesp 80 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 80 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: EU/1/01/185/021 1 pack EU/1/01/185/022 4 pack EU/1/01/185/096 1 pack with needle guard EU/1/01/185/097 4 pack with needle guard
Icelandic: EU/1/01/185/021 1 sprauta í pakkningu EU/1/01/185/022 4 sprautur í pakkningu EU/1/01/185/096 1 sprauta í pakkningu með nálarvörn EU/1/01/185/097 4 sprautur í pakkningu með nálarvörn
English: Aranesp 150 micrograms solution for injection in pre-filled syringe.
Icelandic: Aranesp 150 míkrógrömm stungulyf, lausn í áfylltri sprautu.
English: EU/1/01/185/103 4 Pack
Icelandic: EU/1/01/185/103 4 hettuglös
English: • Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Icelandic: Greint hefur verið frá alvarlegum útbrotum í húð í tengslum við epóetínmeðferð, m.a. Stevens-Johnson-heilkenni og eitrunardrepi í húðþekju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/185/043
Icelandic: MARKAÐSLEYFISNÚMER EU/1/01/185/043
English: EU/1/01/185/009 1 pack EU/1/01/185/010 4 pack EU/1/01/185/082 1 pack with needle guard EU/1/01/185/083 4 pack with needle guard
Icelandic: EU/1/01/185/009 1 sprauta í pakkningu EU/1/01/185/010 4 sprautur í pakkningu EU/1/01/185/082 1 sprauta í pakkningu með nálarvörn EU/1/01/185/083 4 sprautur í pakkningu með nálarvörn