FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Icelandic: Sjúklingar sem fengu lyfleysu skv. slembiröðun, fengu lyfleysu í viku 0 og viku 4 en fengu síðan ustekinumab (annaðhvort 45 mg eða 90 mg) í viku 12 og viku
English: Recommended Dose
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF
English: In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
Icelandic: 52 hjá 47% eftir 45 mg og hjá 48% eftir 90 mg.
English: • Do not shake Stelara vials.
Icelandic: Ekki hrista Stelara hettuglös.
English: Each vial contains 45 mg of ustekinumab in 0.5 mL.
Icelandic: Hvert hettuglas inniheldur 45 mg af ustekinumabi í 0,5 ml.
English: Table 2 List of adverse reactions System Organ Class
Icelandic: Tafla 2 Listi yfir aukaverkanir
English: A beneficial effect was also observed in induction in patients who failed at least one prior TNFα antagonist therapy and vedolizumab, however the number of patients in this subgroup was too small to draw definitive conclusions about the beneficial effect in this group during maintenance.
Icelandic: Fjöldi sjúklinga í þessum undirhópi var þó of lítill til þess að draga ákveðna ályktun um jákvæð áhrif hjá þeim hópi meðan á viðhaldsmeðferð stóð.
English: Patients randomised PGA
Icelandic: Slembiraðaðir sjúklingar
English: Each vial contains 90 mg of ustekinumab in 1 mL.
Icelandic: Hvert hettuglas inniheldur 90 mg af ustekinumabi í 1 ml.
English: Combined Symptomatic Remission and Mucosal Healing
Icelandic: Samantekið hlé á einkennum og slímhimnugræðing
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 10).
Icelandic: Klínísk svörun og sjúkdómshlé viðhélst hjá marktækt stærra hlutfalli sjúklinga í ustekinumab hópunum miðað við í lyfleysu hópnum í viku 44 (sjá töflu 10).
English: Any unused product remaining in the syringe should be thrown away.
Icelandic: Öllum lyfjaleifum í sprautunni á að farga.
English: PASI 75 response N (%) Number of patients > 100 kg
Icelandic: N (%) PGA án einkenna eða með lágmarks einkenni N (%) Fjöldi sjúklinga ≤ 100 kg PASI 75 svörun
English: Improvements in enthesitis score and dactylitis score were maintained through weeks 52 and 100.
Icelandic: Svörun samkvæmt viðmiðun svörunar við meðferð psoriasis liðagigtar hélst út viku 52 og viku 100.
English: b 60 (28.7%) 116 (55.5%) Clinical Response (100 point), week 8 50 (20.2%) 94 (37.8%)
Icelandic: b 60 (28,7%) 116 (55,5%)
English: The solution should be visually inspected for particulate matter or discoloration prior to subcutaneous administration.
Icelandic: Lausnina skal skoða sjónrænt með tilliti til agna eða mislitunar fyrir gjöf undir húð.
English: Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising.
Icelandic: Mótefni, að mestu hlutleysandi, gegn ustekinumabi geta myndast meðan á meðferð með ustekinumabi stendur.
English: • burning when passing water
Icelandic: • sviði við þvaglát
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 4).
Icelandic: Klínísk svörun og sjúkdómshlé viðhélst hjá marktækt stærra hlutfalli sjúklinga í ustekinumab hópunum miðað við í lyfleysu hópnum í viku 44 (sjá töflu 4).
English: Common: Upper respiratory tract infection, nasopharyngitis, sinusitis
Icelandic: Ofnæmislungnablöðrubólga, eósínófíl lungnabólga
English: • Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
Icelandic: Haltu um bol áfylltu sprautunnar og láttu nálina með nálarhettunni vísa upp.
English: Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Icelandic: Fylgjast skal vel með ummerkjum og einkennum virkrar berklasýkingar hjá sjúklingum á STELARA meðan á meðferð stendur og eftir að meðferð lýkur.
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Icelandic: Forðast skal að velja stungustað á húð þar sem einkenni eru um psoriasis ef hægt er.
English: The proportion of patients achieving a modified PsA response criteria (PsARC) response was also significantly greater in the ustekinumab groups compared to placebo at week 24.
Icelandic: Hlutfall sjúklinga sem hafði svarað meðferð í 24. viku, samkvæmt aðlöguðum viðmiðunum svörunar við meðferð psoriasis liðagigtar (PsARC), var einnig marktækt stærra í hópunum sem fengu meðferð með ustekinumabi samanborið við lyfleysu.
English: STELARA concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.
Icelandic: Heilbrigðisstarfsmaður á að þynna og undirbúa Stelara innrennslisþykkni, lausn að viðhafðri smitgát.
English: • Infections of the chest are uncommon (may affect up to 1 in 100 people)
Icelandic: Sýkingar í neðri hluta öndunarfæra eru sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum).
English: Mucosal healing is defined as a Mayo endoscopic subscore of 0 or 1.
Icelandic: Slímhimnugræðing er skilgreind sem Mayo undirskor með holsjá sem nemur0eða1.
English: Common: Pruritus
Icelandic: 13. LOTUNÚMER
English: Each vial contains 90 mg ustekinumab in 1 mL.
Icelandic: Hvert hettuglas inniheldur 90 mg ustekinumab í 1 ml.
English: • the vial is not damaged and the seal is not broken
Icelandic: • hettuglasið sé óskemmt og innsigli órofið.
English: Malignancies
Icelandic: Natríuminnihald
English: It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial.
Icelandic: Lyfið kemur í öskju með 1 skammti í 30 ml glerhettuglasi.
English: The solution should be visually inspected for particulate matter or discoloration prior to administration.
Icelandic: Lausnina skal skoða sjónrænt með tilliti til agna eða mislitunar fyrir gjöf.
English: Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
Icelandic: Hver áfyllt sprauta inniheldur 90 mg af ustekinumabi í 1 ml.
English: • For instructions on how to inject Stelara, see ‘Instructions for administration' at the end of this leaflet.
Icelandic: Stelara inndælingu í „Leiðbeiningar um lyfjagjöf“ sem eru aftast í fylgiseðlinum.
English: Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 12).
Icelandic: Marktækt stærra hlutfall sjúklinga voruí klínísku sjúkdómshléi í báðumhópunum sem fengu meðferð með ustekinumabi, samanborið við lyfleysuhópinn í viku44 (sjá töflu12).
English: Each vial contains 45 mg ustekinumab in 0.5 mL.
Icelandic: Hvert hettuglas inniheldur 45 mg ustekinumab í 0,5 ml.
English: In the treatment regimen, the first dose of STELARA is administered intravenously.
Icelandic: Samkvæmt meðferðaráætlun á að gefa fyrsta skammtinn af STELARA í bláæð.
English: • the number of pre-filled syringes and strength is correct o If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
Icelandic: Ef skammturinn er 90 mg notar þú eina 90 mg áfyllta sprautu af Stelara.
English: VIAL CARTON TEXT (90 mg)
Icelandic: MERKIMIÐI HETTUGLASS (90 mg)
English: Tell your doctor or pharmacist:
Icelandic: Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
English: Each vial contains 90 mg ustekinumab in 1 mL of solution for injection.
Icelandic: Hvert hettuglas inniheldur 90 mg af ustekinumabi í 1 ml af stungulyfi, lausn.
English: Any unused product remaining in the vial and the syringe should be thrown away.
Icelandic: Öllum lyfjaleifum í hettuglasinu og sprautunni á að farga.
English: Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Icelandic: Hvert hettuglas inniheldur 45 mg af ustekinumabi í 0,5 ml af stungulyfi, lausn.
English: VIAL CARTON TEXT (45 mg)
Icelandic: MERKIMIÐI HETTUGLASS (45 mg)
English: • Do not hold by the plunger head, plunger, needle guard wings, or needle cover
Icelandic: Ekki halda um stimpilhausinn, stimpilinn, nálarhlífavængina eða nálarhettuna.
English: Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
Icelandic: Hver áfyllt sprauta inniheldur 45 mg ustekinumab í 0,5 ml.
English: Week 16 Responders to Ustekinumab Induction Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients).
Icelandic: 90 mg gjöf af ustekinumabi undir húð í viku 8 (36% sjúklinga).
English: There were no indications of an interaction with these concomitantly administered medicinal products.
Icelandic: Við samhliða gjöf voru engar vísbendingar um milliverkanir við þessi lyf.
English: Recommended dose
Icelandic: Leiðbeiningar um lyfjagjöf
English: Placebo
Icelandic: lyfleysa
English: STELARA 45 mg solution for injection in pre-filled syringe Ustekinumab
Icelandic: STELARA 45 mg stungulyf, lausn í áfylltri sprautu Ustekinumab
English: STELARA 45 mg solution for injection in pre-filled syringe ustekinumab
Icelandic: STELARA 45 mg stungulyf, lausn í áfylltri sprautu ustekinumab
English: STELARA 90 mg solution for injection in pre-filled syringe Ustekinumab
Icelandic: STELARA 90 mg stungulyf, lausn í áfylltri sprautu ustekinumab
English: Stelara contains the active substance ‘ustekinumab', a monoclonal antibody.
Icelandic: Stelara inniheldur virka efnið ustekinumab, sem er einstofna mótefni.
English: • Take the pre-filled syringe(s) out of the refrigerator.
Icelandic: Taktu áfylltu sprautuna (sprauturnar) úr kæli.
English: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL of solution for injection.
Icelandic: Hver áfyllt sprauta inniheldur 90 mg af ustekinumabi í 1 ml af stungulyfi, lausn.
English: Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
Icelandic: STELARA í klínískum rannsóknum fengu illkynja sjúkdóma í húð eða annars staðar í líkamanum (sjá kafla 4.8).
English: At week 12, placebo treated patients crossed over to receive ustekinumab.
Icelandic: Sjúklingar sem fengið höfðu lyfleysu fóru yfir á ustekinumab í viku
English: Table 1 Initial intravenous dosing of STELARA Body weight of patient at the time of dosing
Icelandic: STELARA í bláæð Þyngd sjúklings þegar skammturinn er gefinn
English: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Icelandic: Hver áfyllt sprauta inniheldur 45 mg af ustekinumabi í 0,5 ml af stungulyfi, lausn.
English: • Redness and pain where the injection is given
Icelandic: Líkamsþyngd þegar skammtur er gefinn
English: STELARA 130 mg concentrate for solution for infusion
Icelandic: STELARA 130 mg innrennslisþykkni, lausn
English: The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebocontrolled, multicenter studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2).
Icelandic: Öryggi og verkun ustekinumabs var metin í tveimur slembiröðuðum, tvíblindum, fjölsetra samanburðarrannsóknum með lyfleysu hjá fullorðnum sjúklingum með meðalvirka eða mjög virka sáraristilbólgu
English: It is supplied as a carton pack containing 1 single-dose, glass 2 mL vial.
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
Icelandic: Innrennsliskammtur ustekinumabs samkvæmt þyngdarháðri skammtaáætlun samkvæmt töflu
English: Common: Fatigue, injection site erythema, injection site pain Uncommon: Injection site reactions (including haemorrhage, haematoma, induration, swelling and pruritus), asthenia
Icelandic: Viðbrögð á stungustað (þar á meðal blæðing, margúll, hersli, bólga og kláði), þróttleysi
English: Patients originally randomised to ustekinumab who achieved Psoriasis Area and Severity Index 75 response (PASI improvement of at least 75% relative to baseline) at both Weeks 28 and 40 were re-randomised to receive ustekinumab every 12 weeks or to placebo (i.e., withdrawal of therapy).
Icelandic: Area and Severity Index - að minnsta kosti 75% bati miðað við grunngildi) bæði í viku
English: • Reduce the signs and symptoms of your disease.
Icelandic: draga úr einkennum sjúkdómsins.
English: Psoriatic arthritis Study 2
Icelandic: Psoriasis liðagigt, rannsókn
English: Systemic
Icelandic: Ónæmisaðgerðir
English: Strength Pharmaceutical Form
Icelandic: Styrkleiki Lyfjaform
English: * Antigenic mass ELISA units.
Icelandic: *Magn mótefnavaka, ELISA einingar.
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Icelandic: - Leptospira interrogans undirhópur Canicola afbrigði Portland-vere (stofn Ca-12-000)
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Icelandic: - Leptospira interrogans undirhópur Australis afbrigði Bratislava (stofn As-05-073)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Icelandic: - Leptospira kirschneri undirhópur Grippotyphosa afbrigði Dadas (stofn Gr-01-005)
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Icelandic: - Leptospira interrogans undirhópur Icterohaemorrhagiae afbrigði Copenhageni (stofn Ic
English: EMEA Number
Icelandic: ESB markaðsleyfisnúmer
English: Immediate Packaging Pack size
Icelandic: Pakkninga stærð
English: Ocular use vial (glass)
Icelandic: Til notkunar í auga hettuglas (gler)
English: EMA Number
Icelandic: Íkomuleið
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Icelandic: EMA-verkefnisnúmer (Sér) heiti
English: See situations in which this product should never be used in section 2.
Icelandic: Sjá aðstæður þar sem aldrei má nota lyfið í kafla 2.
English: OTHER SPECIAL WARNING(S):
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF:
English: [This statement below should be strongly emphasised (e.g. capitalized, bold letters or use of colours), the visual details of the warning on the outer and immediate packaging should be agreed with NCAs and be subject to a user test taking into account the "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use" within 1 month from the Commission Decision.]
Icelandic: [Leggja þarf mikla áherslu á yfirlýsinguna hér að neðan (t.d. með hástöfum, feitletruð eða í litum), yfirvöld aðildarlandanna þurfa að samþykkja útlit varnaðarorðanna á ytri og innri umbúðum og framkvæma skal notandapróf innan 1 mánaðar frá ákvörðun framkvæmdastjórnarinnar með tilliti til “Guideline on the Readability of the labelling and package leaflet on medicinal products for human use„]
English: LABELLING
Icelandic: Varnaðarorð
English: MAHs of HES solution for infusion should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Icelandic: Markaðsleyfishafar HES innrennslislausna skulu breyta lyfjaupplýsingunum (bæta við, skipta út eða eyða texta, eftir því sem við á) til að endurspegla orðalagið eins og kveðið er á um hér að neðan og í tengslum við vísindalegu niðurstöðurnar:
English: PACKAGE LEAFLET [This statement below should be added in a black box at the top of the package leaflet.]
Icelandic: FYLGISEÐILL [Bæta skal yfirlýsingunni hér að neðan við í svörtum kassa efst í fylgiseðilinn.]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Icelandic: Yfirvöld aðildarlandanna geta síðan uppfært lyfjaupplýsingarnar í samráði við viðmiðunarlandið, eftir því sem við á, í samræmi við ferlin sem mælt er fyrir um í 4. kafla í III.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Icelandic: Þessar breytingar á viðeigandi köflum í samantekt á eiginleikum lyfs og fylgiseðli eru niðurstaða málskotsferlisins.
English: Annex III Amendments to relevant sections of the Product Information
Icelandic: Viðauki III Breytingar á viðeigandi köflum í lyfjaupplýsingunum
English: SEE ALL CONTRAINDICATIONS IN THE SMPC.
Icelandic: SJÁ ALLAR FRÁBENDINGAR
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM
English: DO NOT USE IN SEPSIS, RENAL IMPAIRMENT, OR CRITICALLY ILL PATIENTS.
Icelandic: MÁ EKKI NOTA HJÁ SJÚKLINGUM MEÐ SÝKLASÓTT (SEPSIS), SKERTA NÝRNASTARFSEMI EÐA HJÁ ALVARLEGA VEIKUM SJÚKLINGUM.
English: Warning Do not use in sepsis (severe generalised infection), renal impairment, or critically ill patients.
Icelandic: Má ekki nota hjá sjúklingum með sýklasótt (alvarlega útbreidda sýkingu), skerta nýrnastarfsemi eða hjá alvarlega veikum sjúklingum.
English: Do not use in foals under the age of 6 months.
Icelandic: Ekki ætlað folöldum undir 6 mánaða aldri.
English: Otto Hahnweg 24 3542 AX Utrecht NETHERLANDS
Icelandic: VETCOOL B.V. Otto Hahnweg 24 3542 AX Utrecht HOLLAND
English: Appropriate precautions must be taken for such horses to ensure compliance with competition regulations.
Icelandic: Gera verður viðeigandi varúðarráðstafanir vegna slíkra hesta til þess að tryggja að keppnisreglum sé fylgt.
English: The terminal half-life following oral administration is 350-500 minutes and no accumulation occurs following repeated oral dosing.
Icelandic: Lokahelmingunartími eftir inntöku er 350-500 mínútur og engin uppsöfnun verður eftir endurtekna skammta til inntöku.
English: Twice daily administration.
Icelandic: Gefið tvisvar á dag.
English: Date of last renewal: 13 November 2007
Icelandic: 13 nóvember 2007
English: Horse.
Icelandic: Hestar
English: 130 mg For the full list of excipients, see section 6.1.
Icelandic: 130 mg Sjá lista yfir öll hjálparefni í kafla 6.1.
English: Bioavailability after oral administration is 80-90%, but is reduced significantly if medication is administered with food.
Icelandic: Aðgengi eftir gjöf til inntöku er 80-90% en minnkar marktækt ef lyfið er gefið með fóðri.
English: Kidney Liver Muscle Fat
Icelandic: Nýru Lifur Vöðvar Fita
English: EXPIRY DATE EXP: {Month/year}
Icelandic: FYRNINGARDAGSETNING EXP {mánuður /ár}
English: Treatment can be continued for a maximum of 14 consecutive days.
Icelandic: Meðferð má halda áfram í hámark 14 daga samfellt.
English: Both enantiomers are equipotent PGF2α antagonists.
Icelandic: Báðar handhverfurnar eru jafn virkar sem PGF2α hemlar.
English: Approximately 70% of an orally administered dose is excreted in the urine.
Icelandic: Um 70% af skammti til inntöku skilst út í þvagi.
English: Water (minimum purified grade), Propylene glycol, Hydroxyethylcellulose, Potassium hydroxide (E525), Hydrochloric acid, Chocolate flavour.
Icelandic: Vatn (lágmarks hreinsunarstig) própýlen glýkól, hýdroxýetýlcellulósi, kalíum hýdroxíð (E525), saltsýra,
English: Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate.
Icelandic: Í rannsóknum á hestum hefur verið sýnt fram á öfluga bælingu á nýmyndun prostaglandíns E2 (PG E2) í vilsu og á nýmyndun tromboxans B2 í sermi og vilsu.
English: In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
Icelandic: Ef um er að ræða fyrirbyggjandi meðferð er hámarkslengd meðhöndlunar 7 dagar samfellt nægileg.
English: The product is presented as a single syringe in a carton box or as a multipack of 3 syringes in a carton box.
Icelandic: Lyfið fæst sem ein dæla í pappaöskju eða 3 dælur í pappaöskju.
English: In case of doubt, it is advisable to test the urine.
Icelandic: Í vafatilvikum er ráðlegt að rannsaka þvag.
English: The active substance in Quadrisol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Icelandic: DÝRALYFJALEIFA Virka efnið í Quadrisol er leyft innihaldsefni samkvæmt lýsingu í töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010:
English: Vedaprofen:
Icelandic: Vedaprófen:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu(http://www.ema.europa.eu/).
English: A 30 ml adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white and natural).
Icelandic: 30 ml stillanleg margskammta dæla úr háþéttni pólýetýleni (hvítu) og lágþéttni pólýetýleni (hvítu og húðlituðu).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Icelandic: 2 mánuðir Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á umbúðunum á eftir EXP
English: No special precautions for storage.
Icelandic: Engar sérstakar varúðarreglur um geymslu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Icelandic: HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR Markaðsleyfishafi:
English: Both enantiomers contribute to therapeutic actions of the compound.
Icelandic: Báðar handhverfurnar stuðla að lækningalegri verkun efnasambandsins.
English: The advised dosage is an initial dose of 2 mg/kg (2.0 ml/100 kg) followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Icelandic: Ráðlagður skammtur er byrjunarskammtur sem nemur 2 mg/kg (2,0 ml/100 kg) og síðan viðhaldsskammtur sem nemur 1 mg/kg (1,0 ml/100 kg) gefinn á 12 klukkustunda fresti.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/)
Icelandic: 14. DAGSETNING SÍÐUSTU SAMÞYKKTAR FYLGISEÐILSINS Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
English: An initial dose of 2 mg/kg (2.0 ml/100 kg) is followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Icelandic: Eftir byrjunarskammt sem nemur 2 mg/kg (2,0 ml/100 kg) skal gefa viðhaldsskammt sem nemur 1 mg/kg (1,0 ml/100 kg) á 12 klukkustunda fresti.
English: Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects.
Icelandic: Önnur bólgueyðandi verkjalyf, þvagræsilyf og efnasambönd með mikla próteinbindingu geta keppt um bindingu og valdið eituráhrifum.
English: BATCH NUMBER Lot: {number}
Icelandic: LOTUNÚMER Lot {númer}
English: The most abundant metabolite is a monohydroxylated derivative.
Icelandic: Umbrotsefnið sem mest er af er mónóhýdroxýleruð afleiða.
English: Vedaprofen is highly bound to plasma proteins and extensively metabolised.
Icelandic: Vedaprófen er mjög bundið plasmapróteinum og umbrotnar í miklum mæli.
English: All metabolites of vedaprofen were shown to be less active than the parent compound as determined by a thromboxane B2 formation inhibition assay.
Icelandic: Öll umbrotsefni vedaprófens reyndust vera minna virk en móðurefnasambandið samkvæmt niðurstöðum úr prófun á bælingu tromboxan B2 myndunar.
English: Quadrisol must not be given with other NSAIDs or glucocorticosteroids.
Icelandic: Quadrisol má ekki gefa með öðrum bólgueyðandi verkjalyfjum eða sykursterum.
English: SPECIAL STORAGE CONDITIONS No special precautions for storage.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Engar sérstakar varúðarreglur um geymslu.
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Icelandic: 17. LOTUNÚMER FRAMLEIÐANDA Lot {númer}
English: Bodyweight and dosage must be accurately determined to avoid overdosing.
Icelandic: Líkamsþyngd og skammta þarf að ákvarða nákvæmlega til að forðast ofskömmtun.