FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase I/II trial including 21 patients, a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core was detected: higher doses of 5-ALA enhanced the fluorescence quality and the fluorescence extent of the tumour core compared to demarcation of the tumour core under standard white illumination in a monotone, non-falling fashion.
Icelandic: 21 sjúklings komu fram skammta-verkunartengsl milli skammtastærða og umfangs og gæða fljúrljómunar í æxliskjarnanum: stærri skammtar af 5-ALA juku bæði gæði og umfang flúrljómunar æxliskjarnans samanborið við afmörkun æxliskjarnans undir hefðbundinni hvítri lýsingu á einhalla, ófallandi máta (in a monotone, non-falling fashion).
English: The administration volume needed to achieve the intended dose for the individual patient can be calculated according to the equation below:
Icelandic: Hægt er að reikna út magnið sem gefa þarf til að ná tilætluðum skammti fyrir hvern sjúkling með jöfnunni hér fyrir neðan:
English: 5-ALA as drinking solution is rapidly and completely absorbed and peak plasma levels of 5-ALA are reached 0.5-2 hours after oral administration of 20 mg/kg body weight.
Icelandic: 5-ALA í formi mixtúru frásogast hratt og fullkomlega og plasmagildi 5-ALA ná hámarki 0,5-2 klst.
English: Further frequently observed side effects are vomiting, nausea and increase of blood bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and blood amylase.
Icelandic: Auk þess eru tíðar aukaverkanir uppköst, ógleði og aukinn gallrauði, alanínamínótransferasi, aspartatamínótransferasi, gammaglútamýltransferasi og amýlasi í blóði.
English: One bottle of Gliolan 30 mg/ml powder for oral solution reconstituted in 50 ml of drinking water corresponds to a total dose of 1500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Icelandic: Eitt glas af Gliolan 30 mg/ml mixtúrudufti, lausn sem blandað er í 50 ml af drykkjarvatni samsvarar heildarskammti sem er 1.500 mg af 5-amínólevúlínsýru-hýdróklóríði (5-ALA HCl).
English: Peak values occurred between 7 and 14 days after administration.
Icelandic: Gildin náðu hámarki 7 til 14 dögum eftir lyfjagjöf.
English: Systemic administration of 5-ALA results in an overload of the cellular porphyrin metabolism and accumulation of PPIX in various epithelia and cancer tissues.
Icelandic: Þegar 5-ALA berst almennt um líkamann veldur það ýktum porfýrínumbrotum í frumunum og uppsöfnun á PPIX í ýmsum þekju- og krabbameinsvefjum.
English: What Gliolan looks like and contents of the pack
Icelandic: Lýsing á útliti Gliolan og pakkningastærðir
English: Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Icelandic: Frekari aukaverkanir sem oft sjást eru uppköst, velgja (ógleði) og lítilsháttar aukning sumra ensíma (transamínasa, γ-GT, amýlasa) eða gallrauða (galllitarefni sem framleitt er í lifrinni með niðurbroti á rauðu litarefni) í blóði.
English: Explanations for higher 5-ALA uptake include a disrupted blood-brain barrier, increased neo-vascularisation, and the overexpression of membrane transporters in glioma tissue.
Icelandic: Skýringar á meiri upptöku 5-ALA eru m.a. truflun á blóð-heila þröskuldinum, aukin æðanýmyndun og yfirtjáning á himnuflutningsefnum í tróðæxlisvef.
English: This medicine is a powder for oral solution.
Icelandic: Lyfið er afgreitt sem mixtúruduft, lausn.
English: The recommended dose is 20 mg 5-ALA HCl per kilogram body weight.
Icelandic: Ráðlagður skammtur er 20 mg af 5-ALA HCl á hvert kg líkamsþyngdar.
English: One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Icelandic: Einn ml af blandaðri lausn inniheldur 23,4 mg af 5-amínólevúlínsýru, sem samsvarar 30 mg af 5-amínólevúlínsýru-hýdróklóríði (5-ALA HCl).
English: neurological disorders (e.g.
Icelandic: Líkamsþyngd sjúklings (kg)
English: Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.
Icelandic: Gliolan er notað til þess að gera sýnileg tiltekin heilaæxli (sem nefnast illkynja tróðæxli) meðan þau eru numin brott í skurðaðgerð.
English: Procedure-related side effects
Icelandic: Aukaverkanir sem tengjast aðgerðinni í heild
English: This medicinal product shows good solubility in aqueous solutions.
Icelandic: Lyfið hefur reynst leysast vel upp í vatnslausnum.
English: Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits.
Icelandic: Brottnám með leiðsögn flúrljómunar hjá sjúklingum af því tagi hefur reynst valda aukinni hættu á grafalvarlegum taugrænum fötlunum.
English: Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.
Icelandic: Mæður með barn á brjósti ættu að gera hlé á brjóstagjöf í 24 klst.
English: In combination with anaesthesia and tumour resection further side effects may occur:
Icelandic: Þegar við bætist svæfing og brottnám æxlisins getur orðið vart frekari aukaverkana:
English: Mild alterations of blood cell counts (red and white cells, platelets), and slight increase of some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.
Icelandic: Vægar breytingar á blóðfrumufjölda (rauðum og hvítum blóðkornum, blóðflögum) og örlítil hækkun á tilteknum ensímum (transamínösum, γ-GT, amýlasa) eða gallrauða (litarefni í galli sem lifrin framleiðir með því að brjóta niður blóðrauða sem er rautt litarefni) í blóðinu.
English: 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism.
Icelandic: Efnasmíði 5-ALA temprast af magni af óbundnu hemi inni í frumunum með neikvæðu afturvirkniferli.
English: Therefore, Gliolan should not be used during pregnancy.
Icelandic: Því ætti ekki má nota Gliolan á meðgöngu.
English: The Member States shall agree with the Marketing Authorisation Holder, prior to launch, measures for the implementation of the following:
Icelandic: Áður en lyfið er sett á markað ber aðildarlöndunum að komast að samkomulagi við markaðsleyfishafa um aðgerðir til að koma eftirfarandi á fót:
English: In patients with pre-existing cardiovascular disease, this medicinal product should be used with caution since literature reports have shown decreased systolic and diastolic blood pressure, pulmonary artery systolic and diastolic pressure as well as pulmonary vascular resistance.
Icelandic: Nota ber lyfið með varúð fyrir sjúklinga sem þegar eru haldnir hjarta- eða æðasjúkdómi því að í fræðigreinum hefur verið greint frá lækkun á blóðþrýstingi, bæði í slagbili og þanbili, þrýstingi í lungnaslagæð, bæði í slagbili og þanbili, og jafnframt æðaviðnámi í lungum.
English: Uncommon side effects (may affect up to 1 in 100 people):
Icelandic: Sjaldgæfar aukaverkanir (geta haft áhrif á allt að 1 af hverjum 100 einstaklingum):
English: Respiratory insufficiency and erythema completely resolved.
Icelandic: Hin skerta öndunarstarfsemi og hörundsroðinn gengu fullkomlega tilbaka.
English: photosensitivity reaction, photodermatosis
Icelandic: PPIX-myndun fyrir tilstilli
English: After administration of this medicinal product, exposure of eyes and skin to strong light sources (e.g. operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours.
Icelandic: eftir að lyfið er gefið ber að forðast að láta sterka ljósgeisla skína í augun eða á húðina (t.d. skurðstofuljós, beint sólarljós eða skæra og skarpa innanhússlýsingu).
English: However, 5-ALA induced PPIX formation is significantly higher in malignant tissue than in normal brain.
Icelandic: 5-ALA er þó marktækt meiri í illkynja vef en í eðlilegum heilavef.
English: Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the following two categories:
Icelandic: Aukaverkanir sem sést hafa eftir notkun á lyfinu til þess að nema brott tróðæxli með leiðsögn flúrljómunar skiptast í eftirfarandi tvo flokka:
English: You should not drink or eat for at least 6 hours before anaesthesia.
Icelandic: á mat og drykk í að minnsta kosti 6 klst.
English: nausea
Icelandic: Skammtar
English: Package leaflet: Information for the user Gliolan 30 mg/ml powder for oral solution
Icelandic: Upplýsingar fyrir notanda lyfsins Gliolan 30 mg/ml mixtúruduft, lausn
English: Four hours after oral administration of 20 mg/kg body weight 5-ALA HCl, the maximum PPIX plasma level is reached.
Icelandic: 20 mg/kg líkamsþyngdar af 5-ALA HCl nær PPIX hámarksgildi sínu í plasma.
English: Minimum requirements for a qualified trainer are: - Board-certification as neurosurgeon according to local, national requirements; - Previous successful participation at a training course, or equivalent course during the phase III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
Icelandic: - Að hann hafi tilskilin réttindi til þess að starfa sem taugaskurðlæknir samkvæmt gildandi reglum innanlands; - Að hann hafi sjálfur, með góðum árangri, tekið þátt í afstöðnu þjálfunarnámskeiði eða samsvarandi námskeiði við III.
English: and IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Icelandic: stigs skv. skala WHO); - Nauðsynleg tækni til taugalífeðlisfræðilegs eftirlits við skurðaðgerðir á svæðum sem sjá um mikilvæga heilastarfsemi.
English: During surgery he developed respiratory insufficiency, which was managed by adaptation of ventilation.
Icelandic: á öndunarstarfsemi sjúklingsins, sem meðhöndluð var með því að aðlaga loftun (ventilation).
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.
Icelandic: Eitt glas inniheldur 1,17 g af 5-amínólevúlínsýru (5-ALA), sem samsvarar 1,5 g af 5-ALA HCl.
English: After ingestion, 5-ALA itself is not fluorescent but is taken up by tumour tissue (see section 5.1) and is intracellularily metabolised to fluorescent porphyrins, predominantly PPIX.
Icelandic: Það er hins vegar tekið upp í æxlisvef (sjá kafla 5.1) og umbrotnar inni í frumunum í flúrljómuð porfýrín, einkum PPIX.
English: Decrease of blood pressure (hypotension), brain swelling (brain oedema).
Icelandic: Lækkun á blóðþrýstingi (lágþrýstingur), þroti í heila (heilabjúgur).
English: Decrease of your sense of touch (hypaesthesia), and loose or watery stools (diarrhoea).
Icelandic: Minnkað snertiskyn (minnkað húðskyn) og lausar eða vatnskenndar hægðir (niðurgangur).
English: If you take more Gliolan than you should
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um
English: Therefore this medicine is not recommended in this age group.
Icelandic: Því er ekki mælt með að nota lyfið fyrir þann aldurshóp.
English: The phenomenon of PPIX accumulation in WHO grade III and IV malignant gliomas may be explained by higher 5-ALA uptake into the tumour tissue or an altered pattern of expression or activity of enzymes (e.g. ferrochelatase) involved in haemoglobin biosynthesis in tumour cells.
Icelandic: WHO-skala gæti skýrst af meiri upptöku 5-ALA í æxlisvef eða breyttu tjáningar- eða virknismynstri ensíma (t.d. ferróchelatasa) sem eiga þátt í tillífun blóðrauða í æxlisfrumum.
English: hemiparesis, aphasia, convulsions, hemianopsia)
Icelandic: Taugakvillar (t.d. helftarlömun, málstol, umbrotakrampar, helftarblinda)
English: No trials have been performed in patients with clinically relevant hepatic or renal impairment.
Icelandic: Engar prófanir hafa verið gerðar á sjúklingum með það skerta lifrar- eða nýrnastarfsemi að máli skipti í klínísku tilliti.
English: After surgery the patient also displayed facial erythema.
Icelandic: Eftir aðgerðina kom einnig fram hörundsroði í andliti hjá sjúklingnum.
English: brain oedema
Icelandic: B. FYLGISEÐILL
English: a) Theory and core principles of Gliolan-fluorescence-guided surgery and malignant glioma resection, including methods of eloquent sites identification; b) On-site instructions on the use of the fluorescence-microscope, including pitfalls and recognition of problems; c) Differentiation of fluorescence intensity, maintaining safety distances from eloquent areas; d) The practice of Gliolan-fluorescence-guided surgery (including participation in at least one case using Gliolan-fluorescence-guided surgery in the operating room with on-site instructions on the use of the microscope or demonstration of a fluorescence-guided resection by video); e) The current understanding of the benefits and risks of cytoreductive surgery in the management of patients with malignant gliomas; f) The theoretical base for porphyrin accumulation in malignant gliomas; g) The technical principles behind fluorescence-guided resections using Gliolan; h) How to identify suitable candidates for fluorescence-guided resections using Gliolan; i) How to apply Gliolan in the correct dose and timing regimen, and to understand the importance of concurrent corticosteroids; j) How to identify patients at risk for neurological deficits using fluorescence-guided resections with Gliolan with special focus on aphasias and other critical focal deficits; k) Techniques for intraoperative risk reduction (microsurgical technique, neurophysiological monitoring, choice of approach) and how to implement them; l) How to identify fluorescence for resection through using the operating microscope in a hands-on setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan.
Icelandic: Tæknileg atriði varðandi vefjabrottnám með leiðsögn Gliolan-flúrljómunar; h) Leiðir til að finna þá sjúklinga sem haft gætu gagn af vefjabrottnámi með leiðsögn Gliolan-flúrljómunar; i) Leiðbeiningar um réttar skammtastærðir af Gliolan og tímamörk lyfjagjafar og útskýringar á mikilvægi samhliða notkunar á barksterum; j) Leiðir til að finna þá sjúklinga sem er hætt við að fatlast vegna taugakerfissköddunar í kjölfar vefjabrottnáms með leiðsögn Gliolan-flúrljómunar, með sérstakri áherslu á málstol og aðrar grafalvarlegar staðbundnar fatlanir; k)
English: Most serious side effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism.
Icelandic: Alvarlegustu aukaverkanir eru m.a. blóðleysi, blóðflagnafæð, hvítfrumnafjölgun, taugakvillar og segarek.
English: In a single-arm trial including 21 healthy male volunteers, erythema of the skin could be provoked by direct exposure to UVA light up to 24 hours after oral application of 20 mg/kg body weight 5-ALA HCl.
Icelandic: 21 heilbrigðs karlkyns sjálfboðaliða var unnt að framkalla hörundsroða með því að láta UVA-ljós skína beint á húðina í allt að 24 klst.
English: • in case of known or suspected pregnancy.
Icelandic: ef vitað er um eða grunur leikur á þungun.
English: a) Theory and core principles of Gliolan-fluorescence-guided surgery and malignant glioma resection, including methods of eloquent sites identification; b) On-site instructions on the use of the fluorescence-microscope, including pitfalls and recognition of problems; c) Differentiation of fluorescence intensity, maintaining safety distances from eloquent areas; d) The practice of Gliolan-fluorescence-guided surgery (including participation in at least one case using Gliolan-fluorescence-guided surgery in the operating room with on-site instructions on the use of the microscope or demonstration of a fluorescence-guided resection by video); e) The current understanding of the benefits and risks of cytoreductive surgery in the management of patients with malignant gliomas; f) The theoretical base for porphyrin accumulation in malignant gliomas; g) The technical principles behind fluorescence-guided resections using Gliolan; h) How to identify suitable candidates for fluorescence-guided resections using Gliolan; i) How to apply Gliolan in the correct dose and timing regimen, and to understand the importance of concurrent corticosteroids; j) How to identify patients at risk for neurological deficits using fluorescence-guided resections with Gliolan with special focus on aphasias and other critical focal deficits; k) Techniques for intraoperative risk reduction (microsurgical technique, neurophysiological monitoring, choice of approach) and how to implement them; l) How to identify fluorescence for resection through using the operating microscope in a handson setting in the operating room; m) The benefits and risks of fluorescence-guided resections using Gliolan.
Icelandic: d) Framkvæmd skurðaðgerða með leiðsögn Gliolan-flúrljómunar (þ.m.t. þátttaka á skurðstofu í að minnsta kosti einni skurðaðgerð með leiðsögn Gliolan-flúrljómunar þar sem gefnar eru leiðbeiningar á staðnum í notkun á smásjánni eða sýnikennsla á myndmiðli um vefjabrottnám með leiðsögn flúrljómunar); e) Ríkjandi skoðanir á ávinningi og áhættu frumubrottnáms í skurðaðgerð til meðferðar sjúklinga með illkynja tróðæxli; f) Fræðilegur grunnur porfýrínuppsöfnunar í illkynja tróðæxlum; g)
English: Brain metastases revealed inconsistent or no fluorescence.
Icelandic: Flúrljómun reyndist vera hvikul eða engin í meinvörpum í heila.
English: One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Icelandic: Eitt glas inniheldur 1,17 g af 5-amínólevúlínsýru (5-ALA), sem samsvarar 1,5 g af 5-amínólevúlínsýru-hýdróklóríði (5-ALA HCl).
English: • in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
Icelandic: ef vitað er um eða grunur leikur á bráðri eða langvinnri gerð af porfýríu (þ.e. arfgengri eða áunninni truflun á tilteknum hvötum í myndunarferli blóðrauða sem er rautt litarefni í blóði).
English: Batch
Icelandic: Segarek
English: The resulting fluorescence was used as an intraoperative marker for malignant glioma tissue with the aim of improving the surgical resection of these tumours.
Icelandic: Flúrljómunin sem af hlaust var notuð sem leiðarmerki til þess að aðgreina illkynja tróðæxlisvef meðan á skurðaðgerð stóð með það fyrir augum að betur tækist að nema æxlin brott.
English: diarrhoea
Icelandic: Taugakerfi
English: thromboembolism
Icelandic: 13. LOTUNÚMER
English: Destruction of sebaceous cells, focal epidermal necrosis with a transient acute inflammation and diffuse reactive changes in the keratinocytes as well as transient secondary oedema and inflammation of dermis are observed.
Icelandic: Sem fylgikvilla hefur orðið vart við eyðileggingu á fitukirtlum, staðbundið drep í húðþekju með bráðri en skammvinnri bólgu og útbreiddum viðbragðsbreytingum í hyrnisfrumum og jafnframt skammvinnan bjúg og bólgu í leðurhúð.
English: One bottle contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl).
Icelandic: Eitt glas inniheldur 1,17 g af 5-amínólevúlínsýru, sem samsvarar 1,5 g af 5-amínólevúlínsýruhýdróklóríði (5-ALA HCl).
English: BATCH NUMBER
Icelandic: Fjöldi glasa =
English: Substance-specific side effects:
Icelandic: Geymsluþol blandaðrar lausnar er:
English: See section 4.
Icelandic: Í 24 klst.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Icelandic: Aðildarríkin skulu ganga úr skugga um að allar forsendur og takmarkanir er varða öryggi og verkun við notkun lyfsins, sem lýst er hér á eftir, séu uppfylltar.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Icelandic: Aukaverkanir sem tengjast virka efninu sérstaklega
English: hypesthesia
Icelandic: INNIHALDSLÝSING
English: Powder for oral solution
Icelandic: Blönduð lausn
English: There is dose proportionality between AUC0-inf. of 5-ALA values and different oral doses of this medicinal product.
Icelandic: 5-ALA-gilda og mismunandi mixtúruskammta af lyfinu.
English: This medicinal product should, therefore, not be administered to pregnant women.
Icelandic: Með þetta í huga skal ekki gefa konum á meðgöngu þetta lyf.
English: Nederland AST Farma B.V.
Icelandic: Nederland Farma B.V.
English: SACHETS (3, 9 and 18 gram)
Icelandic: SKAMMTAPOKAR (3, 9 og 18 grömm)
English: Treatment may be repeated at 24 hour intervals during 10 consecutive days.
Icelandic: Endurtaka má meðferð með 24 klst. millibili í 10 daga samfellt.
English: Excretion of prednisolone is complete within 3 days.
Icelandic: Útskilnaði prednisólons lýkur á innan við 3 dögum.
English: Sachets of different pack size can be combined to achieve the correct dose, as per the table below:
Icelandic: Skammtapoka af mismunandi pakkningastærðum má nota saman til þess að fá fram réttan skammt eins og kemur fram í töflunni hér á eftir:
English: The correct dose should be mixed into a small amount of food.
Icelandic: Blanda skal réttum skammti í lítið magn fóðurs.
English: 33.3 mg
Icelandic: prednisólon 33,3 mg
English: Each case should be assessed individually by the veterinarian and an appropriate treatment program determined.
Icelandic: Dýralæknir skal meta hvert tilfelli fyrir sig og ákveða viðeigandi meðferðaráætlun.
English: The active substance in Equisolon is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Icelandic: Virka efnið í Equisolon er leyft innihaldsefni samkvæmt lýsingu í töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010:
English: ATCvet code: QH02AB06
Icelandic: QH02AB06
English: Package (size)
Icelandic: Pakkning (stærð)
English: Bodyweight (kg) of horse
Icelandic: Líkamsþyngd (kg)hross
English: Keep the jar tightly closed.
Icelandic: Geymið krukkuna vel lokaða.
English: To ensure administration of the correct dose, body weight should be determined as accurately as possible to avoid under- or overdosing.
Icelandic: Til þess að tryggja að réttur skammtur sé gefinn skal ákvarða líkamsþyngd eins nákvæmlega og hægt er svo forðast megi van- eða ofskömmtun.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.emea.europa.eu/.
Icelandic: Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu/.
English: Because corticosteroids can reduce the immunoresponse to vaccination, prednisolone should not be used in combination with vaccines or within two weeks after vaccination.
Icelandic: Þar sem barksterar geta dregið úr ónæmissvörun við bólusetningu skal ekki nota prednisólon samhliða bóluefnum eða innan tveggja vikna eftir bólusetningu.
English: 8203 AA Lelystad
Icelandic: 42 8203 AA Lelystad Holland
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Icelandic: Hjálparefnin sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru ýmist leyfð innihaldsefni sem ekki þurfa gildi fyrir hámark lyfjaleifa samkvæmt töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010 eða talin falla utan reglugerðar (EB) nr. 470/2009 þegar þau eru notuð eins og í þessu dýralyfi.
English: Food mixed with the veterinary medicinal product should be replaced if not consumed within 24 hours.
Icelandic: Skipta skal um mat sem blandaður hefur verið dýralyfi ef hans er ekki neytt innan 24 klst.
English: Horgatun 2
Icelandic: Hörgatún 2
English: Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone.
Icelandic: Aðeins skal hefja meðferð með prednisóloni ef ekki hefur tekist að draga úr klínískum einkennum á fullnægjandi hátt eða ef ólíklegt er að það takist eingöngu með því að taka á umhverfisþáttum.