FrancophonIA/ELRC3.0 huggingface dataset:
English: The symptoms you might experience and the instruction what to do in such cases are described in section 4 of this leaflet.
Icelandic: Í kafla 4 í þessum fylgiseðli er að finna lýsingu á einkennunum sem þú gætir fundið fyrir og því hvaða ráðstafana skuli grípa til í slíkum tilvikum.
English: (Actual air bubble formation may vary)
Icelandic: (Loftbólur í sprautunni geta verið breytilegar)
English: Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections (see section 4.2).
Icelandic: Eftir pegaptanib inndælingu geta bráðar (samdægurs) og síðkomnar blæðingar í glerhlaupi augans átt sér stað (sjá kafla 4.2).
English: The medicine must be discarded if kept at room temperature for more than two weeks.
Icelandic: Farga skal lyfinu ef það hefur verið geymt við stofuhita lengur en í tvær vikur.
English: Endophtalmitis
Icelandic: Taugakerfi
English: A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the medicinal product (see Figure 1, below).
Icelandic: Við inndælingu lyfsins skal nota nál af stærðinni 27 eða 30 G x ½ tommu og festa við luer lock tengið (sjá Mynd 1 hér að neðan).
English: As expected with intravitreal injections, transient increases in intraocular pressure may be seen.
Icelandic: Eins og við er að búast eftir inndælingu í glerhlaup, getur komið fram tímabundin hækkun á augnþrýstingi innan augans.
English: Read all of this leaflet carefully before you start your treatment with this medicine because it contains important information for you.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en byrjað er að nota lyfið.
English: Κύπρος
Icelandic: Kύπρος
English: One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
Icelandic: Ein áfyllt sprauta gefur nægilegt magn til að gefa stakan 90 míkrólítra skammt sem inniheldur pegaptanib natríum sem samsvarar 0,3 mg af fríu sýruformi oligunúkleótíðsins.
English: • elevation of the liver enzymes, abrasion.
Icelandic: • hækkun lifrarensíma, skrámur.
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric (bromobutyl/synthetic isoprene) tip cap.
Icelandic: Sprautan er með áföstu pólýkarbónat luer lock tengi úr plasti og er fremsti hlutinn innsiglaður með teygjanlegri (elastomeric) (brómóbútýl/tilbúið ísópren) hlíf.
English: (vitreous detachment)
Icelandic: 0 (í stöfum)
English: What Macugen looks like and contents of the pack
Icelandic: Lýsing á útliti Macugen og pakkningastærðir
English: - The other ingredients are sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment) and water for injections.
Icelandic: - Önnur innihaldsefni eru: natríumklóríð, natríumfosfateinhýdrat, tvínatríum fosfatheptahýdrat, natríumhýdroxíð og saltsýra (til að stilla sýrustig) og vatn fyrir stungulyf.
English: In humans, the average ± standard deviation apparent plasma half-life of pegaptanib after a 3 mg (10-times the recommended dose) monocular dose is 10 ± 4 days.
Icelandic: Eftir gjöf 3 mg (tífaldur ráðlagður skammtur) í annað augað hjá mönnum er meðaltal +/- staðalfrávik helmingunartíma pegaptanibs í plasma 10 +/- 4 dagar.
English: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Icelandic: Greint hefur verið frá altækum aukaverkunum, þar á meðal blæðingum sem ekki tengdust augum og segareki í slagæðum, í kjölfar inndælingar VEGF-hemla í glerhlaup og það er fræðileg hætta á að þær kunni að tengjast VEGF hömlun.
English: • displacement or tear of a layer in the back of the eye (retina)
Icelandic: • los eða rifnun laga í afturhólfi augans (sjónu)
English: No special considerations are needed in patients with creatinine clearance above 20 ml/min who are treated with the recommended dose of pegaptanib sodium 0.3 mg.
Icelandic: Ekki er þörf á að breyta ráðlögðum 0,3 mg pegabtanib natríum skammti hjá sjúklingum með kreatínín úthreinsun meiri en 20 ml/mín
English: Macugen should be inspected visually for particulate matter and discoloration prior to administration (see section 6.6).
Icelandic: Áður en Macugen er gefið skal ganga úr skugga um að lausnin innihaldi ekki agnir eða sé mislit (sjá kafla 6.6).
English: • small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye,
Icelandic: smá útfellingar í auga eða á yfirborði augans (glæru), útfellingar í afturhólfi augans
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Icelandic: Natríumfosfateinhýdrat, Dinatríum fosfatheptahýdrat, Natríumhýdroxíð (til aðlögunar pH), Saltsýra (til aðlögunar pH), Vatn fyrir stungulyf
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fyrir hjá allt að 1af hverjum 10 einstaklingum)
English: • swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva)
Icelandic: • bólga á augnloki, bólga á innanverðu augnloki eða yfirborði augans (augnslímu)
English: The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Icelandic: Skammtar Áður en inndælingin í glerhlaup hefst á að meta nákvæmlega ofnæmissögu sjúklingsins (sjá kafla 4.4).
English: Respiratory, thoracic and mediastinal disorders Common rhinorrhea
Icelandic: Öndunarfæri, brjósthol og miðmæti Algengar nefrennsli
English: What you need to know before you are given Macugen
Icelandic: Áður en byrjað er að gefa þér Macugen
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Icelandic: Inndælingarferlið skal fara fram við smitgát sem felur í sér sótthreinsun handa eins og um skurðaðgerð sé að ræða, notkun sæfðra hanska, sæfðs dúks og sæfðra augnlokaglennu (eða sambærilegt) og að sæfð ástunguáhöld séu tiltæk (ef nauðsynlegt).
English: • Physician safety brochure
Icelandic: Öryggisbækling fyrir lækna
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Icelandic: Lyfið inniheldur innan við 1 mmól af natríum (23 mg) í hverjum skammti, þ.e.a.s. er nær natríumfrítt.
English: Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
Icelandic: Macugen eingöngu og samtímis ljóshrifameðferð (PDT photodynamic therapy) leiddu ekki í ljós neinn mun á lyfjahvörfum pegaptanibs í plasma.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI
English: The physician safety brochure should contain the following key elements: a) The intravitreal procedure as it was performed in the pivotal clinical studies, along with any technical improvements b) Use of povidone iodine c) Performing lid scrubs d) Use of anaesthetic to ensure patient comfort e) Sterile techniques to minimize the risk of infection f) Use of antibiotics g) Techniques for the intravitreal injection h) Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis,
Icelandic: Notkun sótthreinsiefna (joðs) c) Framkvæmd sótthreinsunar á augnloki d) Notkun róandi lyfja til að tryggja ró sjúklings e) Inndælingu við smitgát, til að lágmarka líkur á sýkingu f) Notkun sýklalyfja g)
English: In advanced disease the initiation and continuation of Macugen therapy should consider the potential for useful vision in the eye.
Icelandic: Hjá sjúklingum með langt genginn sjúkdóm á að hafa líkur á að viðhalda gagnlegri sjón í huga við mat á upphafs- og áframhaldandi Macugen meðferð
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Macugen treatment.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum áður en lyfið er notað.
English: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition.
Icelandic: Segarek í slagæðum er aukaverkun sem hugsanlega tengist altækri VEGF-hömlun.
English: • eversion of the eyelid, eye movement disorder, eyelid irritation
Icelandic: • úthverfing augnloks, truflun í augnhreyfingum, erting í augnlokum
English: Less frequently reported serious ocular adverse reactions included endophthalmitis, retinal haemorrhage, vitreous haemorrhage and retinal detachment.
Icelandic: Meðal alvarlegra aukaverkana sem greint var sjaldnar frá í auga var innri augnknattarbólga (endophthalmitis), blæðing í sjónu, blæðing í glerhlaupi augans og sjónulos.
English: There are no reproductive toxicity studies in rabbits.
Icelandic: Ekki hafa verið gerðar rannsóknir til að meta skaðleg áhrif á frjósemi hjá kanínum.
English: • bloodshot eye (conjunctival haemorrhage)
Icelandic: • blóðhlaupið auga (blæðing í táru)
English: In the clinical trial, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in intravitreal VEGF inhibitor-treated patients.
Icelandic: Í klínísku rannsókninni kom fram smávægileg aukning á heildartíðni blæðinga, sem ekki tengdust augum, sem er aukaverkun sem hugsanlega tengist altækri hömlun á VEGF (æðaþelsvaxtarþætti), hjá sjúklingum sem fengu inndælingu með VEGF-hemlum í glerhlaup.
English: Psychiatric disorders Uncommon nightmare, depression
Icelandic: Sjaldgæfar martraðir, þunglyndi
English: Uncommonly, an infection in the internal portion of the eye can occur after two weeks following Macugen treatment.
Icelandic: Í sjaldgæfum tilfellum getur sýking í framhólfi augans komið fram á fyrstu tveimur vikum eftir gjöf Macugen.
English: • eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil
Icelandic: • bólga í auga, táraflóð, tárubólga, þurrkur, útferð í auga, erting í auga, kláði í auga, roði í auga eða stækkun ljósops.
English: After intravitreal and intravenous administrations of radiolabeled pegaptanib to rabbits, the highest concentrations of radioactivity (excluding the eye for the intravitreal dose) were obtained in the kidney.
Icelandic: Eftir inndælingu geislamerkts pegaptanib í glerhlaup og bláæð kanína, mældist mesta þéttni (fyrir utan augu eftir gjöf í glerhlaup) í nýrum.
English: Before expelling air bubble and excess drug
Icelandic: Mynd 1. Áður en loftbólum og umframrúmmáli lyfsins er dælt út
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection
Icelandic: HEITI LYFS Macugen 0,3 mg stungulyf, lausn.
English: Nervous system disorders Common
Icelandic: Hjarta Sjaldgæfar hjartsláttarónot
English: • irritation and inflammation of the skin, hair colour changes, rash, itching,
Icelandic: erting og bólga í húð, breyting í háralit, útbrot, kláði
English: • eye inflammation
Icelandic: • augnverkur
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Icelandic: Sprautan er með áföstu pólýkarbónat luer lock tengi úr plasti og er fremsti hlutinn innsiglaður með teygjanlegri hlíf.
English: Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.
Icelandic: Natríumklóríð, natríumfosfateinhýdrat, tvínatríum fosfatheptahýdrat, natríumhýdroxíð og saltsýra (til að stilla sýrustig), vatn fyrir stungulyf.
English: • drooping eyelid
Icelandic: • sigin augnlok
English: Eye disorders Very common anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis, vitreous floaters and
Icelandic: Augu Mjög algengar bólga í framhólfi augans, augnverkur, aukinn þrýstingur innan augans, bletta glærubólga, augngrugg og ógegnsætt
English: Not known angioedema*
Icelandic: Tíðni ekki þekkt ofsabjúgur*
English: In animal studies no effects on male or female fertility in mice were observed.
Icelandic: Engin áhrif komu fram á frjósemi karl- eða kvendýra í dýrarannsóknum á músum.
English: In rabbits, the component nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Icelandic: Í kanínum fannst núkleótíðþáttúrinn, 2'-flúoróúridín í plasma og þvagi eftir gjöf eins skammts af Macugen í bláæð og glerhlaup augans.
English: • decreased vision
Icelandic: • minnkaður augnþrýstingur
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose: 0.3 mg/90 µl
Icelandic: 0,3 mg/90 µl
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection pegaptanib
Icelandic: Macugen 0,3 mg stungulyf, lausn Pegaptanib
English: Therefore, the perfusion of the optic nerve head should be verified and elevation of intraocular pressure should be managed appropriately post injection.
Icelandic: Þess vegna á að sannreyna blóðflæði til sjóntaugar og veita viðunandi meðferð við hækkun augnþrýstings eftir inndælingu.
English: VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Icelandic: VEGF er seytiprótein sem kemur af stað æðanýmyndun, gegndræpi æða og bólgu, sem er talið stuðla að framvindu aldurstengdrar votarýrnunar í miðgróf sjónu.
English: The patient information should contain the following key elements: m) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume n) When to seek urgent attention from the health care provider
Icelandic: Upplýsingar fyrir sjúklinga eiga að innihalda eftirtalin lykilatriði: m) Lykileinkenni alvarlegra aukaverkana tengd inndælingu í glerhlaup, þ.m.t. innri augnknattarbólgu,
English: OTHER SPECIAL WARNING(S), IF NECESSARY CAUTION: Expel excess volume before injecting.
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF VARÚÐ:
English: The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure.
Icelandic: Samantekt á öryggi Meirihluti tilkynntra aukaverkana eftir gjöf á Macugen tengjast inndælingunni í glerhlaup.
English: Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Icelandic: Gefa skal fullnægjandi deyfingu og breiðvirkt örveirudrepandi lyf til staðbundinnar notkunar fyrir inndælinguna.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Icelandic: Leitaðu til læknisins eða lyfjafræðings ef þörf er á frekari upplýsingum um notkun lyfsins.
English: Macugen therapy administered to both eyes concurrently has not been studied.
Icelandic: Magucen hefur ekki verið rannsakað þegar það hefur verið gefið í bæði augu samtímis.
English: General disorders and administration site conditions Uncommon fatigue, rigors, tenderness, chest pain, influenza like illness
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Sjaldgæfar þreyta, skjálfti, eymsli, brjóstverkur, flensulík einkenni
English: Pegaptanib does not accumulate in the plasma when administered intravitreally every 6 weeks.
Icelandic: Þegar pegaptanib er gefið í glerhlaup augans á sex vikna fresti á sér ekki stað uppsöfnun í plasma.
English: Dosing line 3rd Rib (top edge)
Icelandic: Skammtalína Þriðji kantur á stimplinum (efri brún)
English: Other common eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Icelandic: Aðrar algengar aukaverkanir frá augum sem greint var frá og eru hugsanlega af völdum lyfsins eða orsakaðar af inndælingunni sjálfri eru:
English: Warnings and precautions Talk to your doctor before you are given Macugen.
Icelandic: Leitið ráða hjá lækninum áður en Macugen er gefið.
English: Pharmacotherapeutic group: Ophthalmologicals, Ocular vascular disorder agents, ATC Code S01LA03.
Icelandic: Augnlyf, efni við æðakvillum í auga, ATC flokkur:
English: Overdose with Macugen has not been reported in clinical trials.
Icelandic: Ekki hefur verið greint frá ofskömmtum Macugen í klínískum rannsóknum.
English: Uncommon nasopharyngitis
Icelandic: bikarlaga sjóntaug
English: Uncommon contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
Icelandic: Húð og undirhúð Sjaldgæfar ofnæmisútbrot, exem, breyting á háralit, útbrot, kláði, nætursviti
English: PHARMACEUTICAL FORM Solution for injection (injection).
Icelandic: LYFJAFORM Stungulyf, lausn.
English: * Post-marketing experience; see “Description of selected adverse reactions”
Icelandic: Sjá „Lýsing á völdum aukaverkunum“
English: Reports from post-marketing experience are included in italics.
Icelandic: * Reynsla eftir markaðssetningu:
English: • disorder of the pupil, of the coloured part of the eye (iris)
Icelandic: • kvillar í sjáaldri, litaða hluta augans (litu)
English: Kypropharm Ltd. Τηλ: + 357 22 43 46 99
Icelandic: România Valeant Pharma S.R.L.Tel: +40 374 102 600
English: Whenever you'll experience vision disturbances, eye discomfort/pain, eye redness or nausea and vomiting, immediately refer to your doctor and tell about your symptoms.
Icelandic: aukinn þrýsting innan augans, skaða á sjónu, blæðingu innan augans, áverkadrer, ofnæmi og inndælingu umframrúmmáls n) Hvenær eigi samstundis að leita hjálpar heilbrigðisstarfsfólks.
English: • visual disturbance
Icelandic: • augnóþægindi
English: Align the third rib of the plunger stopper with the pre-printed black dosing line.
Icelandic: Látið efri brún þriðja kants á stimplinum bera við svörtu áprentuðu skammtalínuna.
English: Skin and subcutaneous tissue disorders
Icelandic: Aukaverkanir tengdar lyfjaflokki
English: • disorder of the surface of the eye (cornea)
Icelandic: • kvilli í yfirborði augans (glæru)
English: No data are available to evaluate male or female mating or fertility indices.
Icelandic: Ekki eru fyrirliggjandi upplýsingar til að meta áhrif á æxlun og frjósemi.
English: • inflammation of the higher respiratory tract, vomiting, indigestion
Icelandic: • hjartsláttarónot, hár blóðþrýstingur, útvíkkun ósæðar (meginæð)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Icelandic: Aukaverkanatilkynningar (áminning)
English: There is a theoretical risk of arterial thromboembolic including stroke and myocardial infarction events following intravitreal use of VEGF inhibitors.
Icelandic: Fræðileg hætta á segareki í slagæðum, þ.m.t. heilaslagi og hjartadrepi, er fyrir hendi í kjölfar notkunar VEGF-hemla í glerhlaup.
English: discontinued
Icelandic: ENDURNÝJUNAR
English: In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
Icelandic: Hjá kanínum skilst pegaptanib út óbreytt og sem umbrotsefni með þvagi.
English: The systemic exposure to pegaptanib is expected to be very low after ocular administration.
Icelandic: Almenn útsetning fyrir pegaptanibi eftir gjöf í auga er talin vera lítil.
English: Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhoea.
Icelandic: öndunarerfiðleikum eða sogkenndum andardrætti, bólgu í munni, andliti, á höndum eða fótum, kláða, yfirliðstilfinningu, hröðum hjartslætti, magakrömpum, ógleði, uppköstum eða niðurgangi.
English: • small lump on your eyelid due to inflammation (chalazion)
Icelandic: smáhnúður á augnloki vegna bólgu (augnaloksþrymill)
English: Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored.
Icelandic: Þess vegna þarf að fylgjast með augnþrýstingi innan augans og með blóðflæði til sjóntaugar.
English: Luxembourg/Luxemburg Bausch & Lomb Pharma nv/sa, Belgium Tél/Tel: + 32 (0)3 280 82 84
Icelandic: Pharma nv/sa, Belgium Tél/Tel:
English: A mean maximum plasma concentration of about 80 ng/ml occurs within 1 to 4 days after a 3 mg monocular dose in humans.
Icelandic: Eftir gjöf 3 mg skammts í annað augað hjá mönnum næst meðaltalshámarksplasmaþéttni, 80 ng/ml, á innan við 1 til 4 dögum.
English: Reductions in the growth of mean total lesion size, choroidal neovascularisation (CNV size), and fluorescein leak size, have been shown in patients with AMD treated with Macugen.
Icelandic: Macugen hefur sést að það dregur úr vexti meðaltalsstærð heildarskemmda, nýæðamyndunar í æðu (choroidal neovascularization) og leka flúrskímulausnar.
English: Uncommon eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Icelandic: Sjaldgæfar aukaverkanir frá augum sem greint hefur verið frá og eru hugsanlega af völdum lyfsins eða vegna inndælingarinnar eru:
English: België/Belgique/Belgien Bausch & Lomb Pharma nv/sa, Belgium Tél/Tel: + 32 (0)3 280 82 84
Icelandic: België/Belgique/Belgien Bausch & Lomb
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POUCH containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á INNRI UMBÚÐUM POKI utan um áfyllta sprautu, stimpilbremsu og áfastan stimpil.
English: • disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear
Icelandic: • kvilli í glerhlaupi augans eins og los eða rof (glerhlaupslos)
English: • increased sensitivity to light, appearance of flashing lights
Icelandic: • aukið ljósnæmi, blossasýn
English: In clinical trials the most frequently reported ocular adverse reactions following injection of Macugen are: anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis,
Icelandic: Algengustu aukaverkanirnar í augum sem voru tilkynntar í klínískum rannsóknum í kjölfar inndælingar með Macugen eru:
English: vitreous floaters and vitreous opacities.
Icelandic: Stoðkerfi og stoðvefur
English: Twenty-four hours after intravitreous administration of a radiolabeled dose of pegaptanib to both eyes of rabbits, radioactivity was mainly distributed in vitreous humour, retina and aqueous humour.
Icelandic: Geislamerkt pegabtanib fannst aðallega í glerhlaupi, sjónu og augnvökva tuttugu og fjórum klst.
English: increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract,
Icelandic: bólga í efri hluta öndunarvegs, uppköst, meltingartruflun
English: The solution to be injected should reach room temperature (below 25°C) before injecting.
Icelandic: á að ná stofuhita (undir 25°C) áður en henni er sprautað inn.
English: Dosing line and top edge of 3rd rib aligned
Icelandic: Efri brún þriðja kants á stimplinum ber við skammtalínuna
English: • itching of the eyelids
Icelandic: • kláði í augnlokum
English: MedDRA system organ class
Icelandic: MedDRA tíðniflokkun
English: Bausch & Lomb Nordic AB Tlf: 800 19 841
Icelandic: Nordic AB Tlf:
English: • inflammation of the eye (iritis)
Icelandic: • ský á auga (drer)
English: Uncommon non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Icelandic: Sjaldgæfar aukaverkanir ekki frá augum sem greint var frá og eru hugsanlega af völdum lyfsins eða vegna inndælingarinnar sjálfrar eru: