FrancophonIA/ELRC3.0 huggingface dataset:
English: Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Icelandic: Icandra 50 mg/1000 mg filmuhúðaðar töflur eru dökkgular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „FLO“ á hinni hliðinni.
English: If you stop taking Icandra
Icelandic: Ef hætt er að taka Icandra
English: Icandra may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Icelandic: 50 mg/850 mg eða 50 mg/1000 mg, tvisvar sinnum á sólarhring, ein tafla að morgni og önnur að kvöldi.
English: Icandra is indicated in the treatment of type 2 diabetes mellitus: - Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Icelandic: 2 - Icandra er ætlað til meðferðar hjá fullorðnum sjúklingum sem ekki ná fullnægjandi blóðsykurstjórnun með stærstu þolanlegu skömmtum af metformini til inntöku, einu sér eða sem eru í samhliða meðferð með vildagliptini og metformini í sitt hvorri töflunni.
English: Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Icandra therapy is recommended.
Icelandic: á AST eða ALT sem nemur þreföldum eðlilegum efri mörkum eða meira er viðvarandi, er mælt með því að hætta meðferð með Icandra.
English: During treatment with Icandra, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Icelandic: einu sinni á ári eða oftar ef þú ert í hópi aldraðra og/eða ef nýrnastarfsemi þín fer versnandi.
English: Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function, or cardiorespiratory illness or sepsis.
Icelandic: Mjólkursýrublóðsýring, sem kemur örsjaldan fyrir en er alvarlegur efnaskiptakvilli, kemur oftast fram við bráða versnandi nýrnastarfsemi eða hjarta- og öndunarfærasjúkdóma eða blóðsýkingu.
English: Other side effects Some patients have experienced the following side effects while taking Icandra:
Icelandic: Nokkrir sjúklingar hafa fengið eftirfarandi aukaverkanir við notkun Icandra:
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Icandra.
Icelandic: Eftirfarandi niðurstöður sýna lyfjahvörf hvors virka efnisins í Icandra fyrir sig.
English: Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Icandra should not be used during breast-feeding (see section 4.3).
Icelandic: á of lágum blóðsykri hjá nýburum í tengslum við notkun metformins og skorts á upplýsingum um notkun vildagliptins hjá mönnum, eiga konur sem hafa barn á brjósti ekki að nota Icandra (sjá kafla 4.3).
English: - For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin:
Icelandic: - Hjá sjúklingum sem ekki ná viðunandi stjórn á tveggja lyfja meðferð með insúlíni og hámarksskammti af metformini sem þolist:
English: The dose of Icandra should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Icelandic: Icandra skal gefa vildagliptin sem 50 mg tvisvar á sólarhring (100 mg heildar sólarhringsskammtur) ásamt þeim skammti af metformini sem þegar er verið að taka.
English: - Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
Icelandic: - Icandra er ætlað samhliða sulphonylurealyfi (þ.e. þríþætt meðferð) sem viðbót við mataræði og hreyfingu hjá fullorðnum sjúklingum sem ekki ná viðunandi blóðsykursstjórnun með metformini og sulphonylurealyfi.
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Icelandic: Ekki má nota Icandra hjá sjúklingum með skerta lifrarstarfsemi, þar með talið sjúklingum með þéttni ALT eða AST > 3x eðlileg efri mörk fyrir meðferð (sjá kafla 4.2, 4.3 og 4.8).
English: - Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Icelandic: - Icandra er ætlað til notkunar í þríþættri meðferð með insúlíni sem viðbót við mataræði og hreyfingu til að bæta blóðsykursstjórnun hjá fullorðnum sjúklingum þar sem insúlín í stöðugum skömmtum og metformin veita ekki viðunandi blóðsykursstjórnun.
English: How to store Icandra
Icelandic: Hvernig geyma á Icandra
English: A test to determine your liver function will be performed before the start of Icandra treatment, at three-month intervals for the first year and periodically thereafter.
Icelandic: Áður en meðferð með Icandra hefst eru gerð próf til að meta lifrarstarfsemina, þau eru gerð á þriggja mánaða fresti fyrsta árið og með reglulegu millibili eftir það.
English: What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Icelandic: Icandra 50 mg/850 mg filmuhúðaðar töflur eru gular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „SEH“ á hinni hliðinni.
English: Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
Icelandic: Lyfjagjöf joðskuggaefna í æð getur leitt til nýrakvilla af völdum skuggaefnis sem leiðir til metforminuppsöfnunar og aukinnar hættu á mjólkursýrublóðsýringu.
English: What Icandra contains - The active substances are vildagliptin and metformin hydrochloride.
Icelandic: - Virku innihaldsefnin eru vildagliptin og metformin hýdróklóríð.
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Icandra should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Icelandic: Skammtar blóðsykurslækkandi meðferðar með Icandra eiga að vera einstaklingsbundnir og byggjast á þeirri meðferðaráætlun sem gildir hjá sjúklingi, verkun og þolanleika, en eiga ekki að vera hærri en ráðlagður hámarksskammtur vildagliptins á sólarhring sem er 100 mg.
English: Icandra 50 mg/1000 mg film-coated tablets
Icelandic: Icandra 50 mg/1000 mg filmuhúðaðar töflur
English: Icandra 50 mg/850 mg film-coated tablets
Icelandic: Icandra 50 mg/850 mg filmuhúðaðar töflur
English: There are no adequate data from the use of Icandra in pregnant women.
Icelandic: Engar fullnægjandi upplýsingar liggja fyrir um notkun Icandra á meðgöngu.
English: If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Icelandic: Ef bráð brisbólga er staðfest skal ekki hefja meðferð með vildagliptini að nýju.
English: - Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Icelandic: - Hver Icandra 50 mg/1000 mg filmuhúðuð tafla inniheldur 50 mg vildagliptin og 1000 mg metformin hýdróklóríð (sem samsvarar 780 mg af metformini).
English: Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Icelandic: Ekki má nota Icandra hjá sjúklingum með skerta lifrarstarfsemi, þar með talið sjúklingum með þéttni alanin aminotransferasa (ALT) eða aspartat aminotransferasa (AST)
English: Icandra should not be used during pregnancy.
Icelandic: Ekki má nota Icandra á meðgöngu.
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
Icelandic: Icandra 50 mg/850 mg filmuhúðaðar töflur Icandra 50 mg/1000 mg filmuhúðaðar töflur
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Icandra may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Icelandic: Icandra getur valdið aukaverkun sem kemur örsjaldan fyrir, en er mjög alvarleg, og kallast mjólkursýrublóðsýring (sjá kaflann „Varnaðarorð og varúðarreglur“).
English: No data are available with regard to overdose of Icandra.
Icelandic: Engar upplýsingar liggja fyrir um ofskömmtun Icandra.
English: It is especially important to mention the following: - glucocorticoids generally used to treat inflammation - beta-2 agonists generally used to treat respiratory disorders - other medicines used to treat diabetes - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
Icelandic: - önnur lyf við sykursýki, - lyf sem auka þvagmyndun (þvagræsilyf) - lyf notuð til meðferðar við verkjum og bólgum (bólgueyðandi verkjalyf og COX-2-hemlar, svo sem íbúprófen og celekoxíb) - ákveðin lyf til meðferðar við háum blóðþrýstingi (ACE hemla og angíótensín II-viðtakablokkar) - ákveðin lyf sem hafa áhrif á skjaldkirtilinn, eða - ákveðin lyf sem hafa áhrif á taugakerfið.
English: Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Icelandic: Icandra 50 mg/1000 mg filmuhúðaðar töflur vildagliptin/metformin hýdróklóríð
English: Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Icelandic: Icandra 50 mg/850 mg filmuhúðaðar töflur vildagliptin/metformin hýdróklóríð
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Icelandic: Icandra 50 mg/850 mg filmuhúðaðar töflur Icandra 50 mg/1000 mg filmuhúðaðar töflur vildagliptin/metformin hýdróklóríð
English: • Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back as well as nausea and vomiting.
Icelandic: Einkennin eru m.a. slæmur og þrálátur kviðverkur (magasvæðið), sem gæti leitt yfir í bakið, sem og ógleði og uppköst.
English: Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Icelandic: Fáanlegt í pakkningum sem innihalda 10, 30, 60, 120, 180 eða 360 filmuhúðaðar töflur og fjölpakkningum sem innihalda 120 (2 öskjur með 60), 180 (3 öskjur með 60) og 360 (6 öskjur með 60) filmuhúðaðar töflur.
English: After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Icelandic: Eftir inntöku metformins, næst hámarks plasmaþéttni (Cmax) eftir um það bil 2,5 klst.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see sections 4.4 and 5.2).
Icelandic: Því skal hafa reglulegt eftirlit með nýrnastarfsemi hjá öldruðum sjúklingum í meðferð með Icandra (sjá kafla 4.4 og 5.2).
English: - For patients switching from co-administration of vildagliptin and metformin as separate tablets: Icandra should be initiated at the dose of vildagliptin and metformin already being taken.
Icelandic: - Hjá sjúklingum sem eru að skipta yfir af samhliða meðferð með vildagliptini og metformini í sitthvorri töflunni:
English: EU/1/08/484/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/036 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: 360 filmuhúðaðar töflur (PA/Ál/PVC/Ál) EU/1/08/484/034 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/035 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/036 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: EU/1/08/484/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/033 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: 360 filmuhúðaðar töflur (PA/Ál/PVC/Ál) EU/1/08/484/031 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/032 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/033 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: Icandra combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Icelandic: Icandra er blanda tveggja sykursýkilyfja með samleggjandi verkun til að bæta blóðsykursstjórn hjá sjúklingum með sykursýki af tegund 2.
English: EU/1/08/484/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/030 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: EU/1/08/484/025 10 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/026 30 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/027 60 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/028 120 filmuhúðaðar töflur (PCTFE/PVC/Ál))
English: In particular, if you are following a diabetic weight control diet, continue with this while you are taking Icandra.
Icelandic: Einkum ef þú ert á sérstöku mataræði til að hafa stjórn á líkamsþyngd í tengslum við sykursýki.
English: - For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Icandra should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Icelandic: Skammtur Icandra skal gefa vildagliptin sem 50 mg tvisvar á sólarhring (100 mg heildar sólarhringsskammtur) ásamt skammti af metformini sem er svipaður því sem þegar er verið að taka.
English: EU/1/08/484/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/024 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: EU/1/08/484/019 10 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/020 30 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/021 60 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/484/022 120 filmuhúðaðar töflur (PCTFE/PVC/Ál))
English: Do not broach more than 50 times.
Icelandic: Stingið ekki oftar en 50 sinnum í tappann.
English: Date of last renewal: 09/08/2016
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis: 09/08/2016
English: Ethanol 99.9%
Icelandic: Etanól 99,9%
English: Tel: +353 (0)1 4515011 Fax: +353 (0)1 4621859
Icelandic: Fax: +353 (0)1 4621859
English: The MAH must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Icelandic: Markaðsleyfishafi skal tryggja að kerfi fyrir lyfjagát, eins og lýst er í 1. hluta í markaðsleyfisumsókninni, hafi verið komið á fót og sé virkt áður en og á meðan lyfið er á markaði.
English: One ml contains:
Icelandic: INNIHALDSLÝSING Einn ml inniheldur:
English: EU/2/11/133/001 EU/2/11/133/002 EU/2/11/133/003
Icelandic: EU/2/11/133/002 EU/2/11/133/003
English: Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland.
Icelandic: Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Írland.
English: Excipient: Ethanol 99.9% 150 mg
Icelandic: Etanól 99,9% 150 mg
English: Marketing authorisation holder and manufacturer responsible for batch release: Bimeda Animal Health Limited,
Icelandic: Heiti og heimilisfang framleiðanda sem er ábyrgur fyrir lokasamþykkt Bimeda Animal Health Limited
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Icelandic: Natríumhýdroxíð (til pH stillingar) Saltsýra (til pH stillingar)
English: MANUFACTURER'S BATCH NUMBER LOT {number}
Icelandic: 17. LOTUNÚMER FRAMLEIÐANDA Lot {númer}
English: MARKETING AUTHORISATION NUMBERS EU/2/11/133/001-003
Icelandic: MARKAÐSLEYFISNÚMER EU/2/11/133/001-003
English: Vials contain 10 ml, 50 ml or 100 ml.
Icelandic: Hettuglös innihalda 10 ml, 50 ml eða 100 ml.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after “EXP”.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og hettuglasinu á eftir EXP.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal 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: Cattle: SC, IV
Icelandic: Nautgripir: s.c., i.v.
English: Pigs: IM
Icelandic: Svín: i.m.
English: The active substance in Recocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Icelandic: Virka efnið í Reocam 20 mg/ml stungulyfi, lausn handa nautgripum, svínum og hestum er leyft innihaldsefni samkvæmt lýsingu í töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No. 37/2010 indicates that no MRLs are required.
Icelandic: Hjálparefnin sem talin eru upp í kafla 6.1 í samantekt á eiginleikum lyfsins eru leyfð innihaldsefni sem ekki þurfa gildi fyrir hámark lyfjaleifa samkvæmt töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Icelandic: Meloxicam er bólgueyðandi verkjalyf (NSAID) af flokki oxicama sem verkar með því að hindra nýmyndun prostaglandína og hefur þar með bólgueyðandi, verkjastillandi, bjúghemjandi og hitalækkandi verkun.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC, IV
Icelandic: ÍKOMULEIÐ(IR) Nautgripir: s.c.,i.v.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING UNITS Glass vial label for 50 ml and 100 ml
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM Hettuglas úr gleri merkimiði fyrir 50 ml og 100ml
English: STATEMENT OF THE MRLS
Icelandic: Hámark lyfjaleifa (MRL)
English: Pack size of 1 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal.
Icelandic: Pakkning með 1 glæru hettuglasi úr gleri af gerð I með teflon húðuðum brómóbútýl gúmmítappa og innsiglað með afrífanlegu flipainnsigli úr áli.
English: Horses: meat and offal: 5 days.
Icelandic: Hestar: Kjöt og innmatur: 5 sólarhringar.
English: In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Icelandic: Örsjaldan geta komið fyrir bráðaofnæmislík viðbrögð sem kunna að reynast alvarleg (þ.m.t. banvæn) og skal meðhöndla einkenni þeirra.
English: LOT {number}
Icelandic: LOTUNÚMER Lot {númer}
English: For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, oral suspensions of meloxicam may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Icelandic: Nota má meloxicam mixtúru, dreifu til framhaldsmeðferðar á bólgum og verkjum vegna bráðra eða langvinnra kvilla í stoðkerfi, í skammtinum 0,6 mg meloxicam/kg líkamsþunga, 24 klst. eftir að lyfið var gefið með inndælingu
English: A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Icelandic: Eftir inndælingu undir húð sást óverulegur og tímabundinn þroti á stungustað hjá innan við 10% nautgripa sem fengu meðferð í klínískum rannsóknum.
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Icelandic: Eftir gjöf tveggja skammta af 0,4 mg meloxicam/kg í vöðva náðist Cmax 1,9 g/ml eftir 1 klst.
English: • Conditions or restrictions with regard to the safe and effective use of the medicinal product
Icelandic: Forsendur eða takmarkanir er varða öryggi og verkun við notkun lyfsins
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Icelandic: Ef sá sem annast lyfjagjöf sprautar sig með dýralyfinu fyrir slysni getur það valdið sársauka.
English: Shelf life after first opening the container: 28 days.
Icelandic: Geymsluþol eftir að umbúðir hafa verið rofnar: 28 sólarhringar.
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Icelandic: Ekki má gefa þetta lyf samtímis sykursterum, öðrum bólgueyðandi verkjalyfjum eða segavarnarlyfjum.
English: Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Icelandic: Einn skammtur, 0,6 mg meloxicam/kg líkamsþunga (þ.e. 3,0 ml/100 kg líkamsþunga), í æð.
English: Horses: IV
Icelandic: Hestar: i.v.
English: Recocam 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
Icelandic: Recocam 20 mg/ml stungulyf, lausn handa nautgripum, svínum og hestum Meloxicam
English: 6.5 Nature and composition of immediate packaging Pack size of 1 Type I clear glass vial with Teflon coated bromobutyl rubber stoppers and sealed with an aluminium flip-off tear-off seal.
Icelandic: Pakkning með 1 glæru hettuglasi úr gleri af gerð I með teflon húðuðum brómóbútýl gúmmítöppum og innsiglað með afrífanlegu flipainnsigli úr áli.
English: Anhydrous citric acid Poloxamer 188
Icelandic: Poloxamer 188
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial label for 10 ml
Icelandic: INNRI UMBÚÐUM Hettuglas úr gleri merkiðmiði fyrir 10 ml
English: EXP {month/year}
Icelandic: EXP: