FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Icelandic: Ibandronic acid Accord 2 mg innrennslisþykkni, lausn Hvert hettuglas inniheldur 2 ml af þykkni.
English: Lumbar spine L2-L4 BMD
Icelandic: Steinefnaþéttni í lendarhrygg L2-L4
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Icelandic: LYFJAFORM Innrennslisþykkni, lausn (sæft þykkni).
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post marketing setting in patients receiving ibandronic acid for osteoporosis (see section 4.8).
Icelandic: Örsjaldan hefur verið tilkynnt um beindrep í kjálka eftir markaðssetningu hjá sjúklingum sem fá íbandrónsýru við krabbameini (sjá kafla 4.8).
English: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
Icelandic: þú ert með einhver vandamál tengd munni eða tönnum, svo sem slæma tannumhirðu,
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Icelandic: Beindrep í hlust (aukaverkun af völdum bisfosfonata)†
English: Mutagenicity/Carcinogenicity
Icelandic: Stökkbreytingarvaldar/Krabbameinsvaldar
English: Up to now there is no experience of acute poisoning with Ibandronic acid Accord concentrate for solution for infusion.
Icelandic: Enn sem komið er, er engin reynsla af bráðri eitrun af völdum Ibandronic acid Accord innrennslisþykknis, lausnar.
English: For total hip BMD, 82.3 % of patients receiving 3 mg injection every 3 months were responders at one year, compared with 75.1 % of patients receiving 2.5 mg daily orally (p=0.02).
Icelandic: 3 mg stungulyf á þriggja mánaða fresti svörun eftir eitt ár, borið saman við 75,1% sjúklinga sem fengu 2,5 mg daglega til inntöku (p=0,02).
English: Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis.
Icelandic: Eftir að meðferð er hætt verður afturhvarf til þeirra meinafræðilegu gilda fyrir meðferð á aukið niðurbrot beina tengdu beinþynningu eftir tíðahvörf.
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Icelandic: Eitt hettuglas með 6 ml af innrennslisþykkni, lausn inniheldur 6 mg íbandrónsýru (sem 6,75 mg íbandrónat natríummónóhýdrat)
English: Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Posology
Icelandic: Sjúklingum sem fá meðferð með íbandrónsýru skal afhenda fylgiseðil og áminningarkort sjúklings.
English: Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Icelandic: Aðrar aukaverkanir íbandrónsýru í rannsóknum á eituráhrifum á æxlun í rottum voru þær sömu og eiga við bisfosfónöt almennt.
English: Only clear solutions without particles should be used.
Icelandic: Einungis skal nota tæra lausnir án agna.
English: Each vial contains 6 mg of ibandronic acid (as sodium monohydrate).
Icelandic: Hvert hettuglas inniheldur 6 mg af íbandrónsýru (sem natríum mónóhýdrat).
English: Intravenous use, for infusion after dilution.
Icelandic: Til notkunar í bláæð, innrennsli eftir þynningu.
English: Care must be taken not to administer ibandronic acid concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Icelandic: Gæta skal þess að Ibandronic acid Accord innrennslisþykkni, lausn sé ekki gefið í slagæð eða utan bláæðar, þar sem það getur valdið vefjaskemmdum.
English: Ibandronic acid, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Icelandic: Íbandrónsýra getur líkt og önnur bisfosfónöt gefin í bláæð valdið tímabundinni lækkun kalsíumgilda í sermi.
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Icelandic: Maga- og garnabólga, magabólga, munnsár, kyngingartregða, varabólga
English: EXP 9.
Icelandic: Tafla 3:
English: Gender
Icelandic: Kynþættir
English: The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 1530 seconds, every three months.
Icelandic: Ráðlagður skammtur af íbandrónsýru er 3 mg, gefið sem inndæling í bláæð á 15 - 30 sekúndum, á þriggja mánaða fresti.
English: • You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord.
Icelandic: Taka á kalk og D-vítamín uppbót á meðan á meðferð með Ibandronic acid Accord stendur.
English: Excipients with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free.
Icelandic: Hjálparefni með þekkta verkun Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverju hettuglasi, þ.e.a.s. er nær natríumlaust.
English: • not enough calcium and vitamin D in the diet
Icelandic: skortur á kalki og D-vítamíni í fæðu
English: Injection site reactions, Asthenia
Icelandic: Viðbrögð á stungustað, þróttleysi
English: Please see the summary of product characteristics for more information.
Icelandic: Vinsamlega lesið samantekt á eiginleikum lyfs fyrir nánari upplýsingar.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as 2.25 mg ibandronate sodium monohydrate).
Icelandic: Eitt hettuglas með 2 ml af innrennslisþykkni, lausn inniheldur 2 mg íbandrónsýru (sem 2,25 mg íbandrónat natríummónóhýdrat)
English: Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones.
Icelandic: Ibandronic acid Accord verkar með því að draga úr kalktapi úr beinum.
English: Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia.
Icelandic: Á grundvelli þekkingar á þessum flokki efnasambanda getur ofskömmtun stungulyfs valdið blóðkalsíumlækkun, blóðfosfatlækkun og blóðmagnesíumlækkun.
English: Blood alkaline phosphatase increase, weight decrease
Icelandic: Hækkun á niðurstöður gammaGT, aukið kreatínín alkalískum fosfatasa í blóði, þyngdartap
English: A statistically significant improvement in bone pain score was shown for intravenous ibandronic acid 6 mg compared to placebo.
Icelandic: Tölfræðilega marktækur bati á beinverkjakvarða kom fram fyrir íbandrónsýru 6 mg í bláæð samanborið við lyfleysu.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with pink flip-off cap.
Icelandic: 6 ml hettuglas úr gleri (af gerð I) með etýlen tetraflúoróetýlen gúmmítappa og álinnsigli með bleiku smelluloki.
English: If you use more Ibandronic acid Accord than you should You may develop low levels of calcium, phosphorus or magnesium in the blood.
Icelandic: Ef notaður er stærri skammtur en mælt er fyrir um Lág gildi kalks, fosfats eða magnesíums í blóði geta komið fram.
English: The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Icelandic: Lyfjahvörf íbandrónsýru voru aðeins metin hjá fáum sjúklingum með nýrnasjúkdóm á lokastigi sem meðhöndlaður var með blóðskilun, því eru lyfjahvörf íbandrónsýru hjá sjúklingum sem ekki fara í blóðskilun ekki þekkt.
English: Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Icelandic: Natríumklóríð, natríumasetat tríhýdrat, ísedik og vatn fyrir stungulyf.
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints.
Icelandic: flensulík einkenni, þar með talin hiti, titringur og skjálfti, vanlíðan, þreyta, beinverkir og verkir í vöðvum og liðum.
English: In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50% of the circulating dose.
Icelandic: 90 l og það magn skammts sem kemst í bein er áætlað 40-50% af skammti í blóðrás.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Icelandic: Ibandronic acid Accord 2 mg innrennslisþykkni, lausn Ibandronic acid Accord 6 mg innrennslisþykkni, lausn íbandrónsýra
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Icelandic: Tilkynnt hefur verið um bráðaofnæmisviðbrögð/lost, þar með talin dauðsföll, hjá sjúklingum sem fengu íbandrónsýru í bláæð.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 2 mg sterile concentrate ibandronic acid
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Ibandronic acid Accord 2 mg sæft þykkni íbandrónsýra i.v. notkun
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ibandronic acid Accord 6 mg sterile concentrate ibandronic acid
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Ibandronic acid Accord 6 mg sæft þykkni íbandrónsýra i.v. notkun
English: dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
Icelandic: á daglegri skömmtun í bláæð voru engar vísbendingar um bein eituráhrif á fóstur eða vansköpunaráhrif hjá rottum og kanínum sem fengu íbandrónsýru.
English: Rare (may affect up to 1 in 1000 people): • hives
Icelandic: Mjög sjaldgæfar (geta haft áhrif á allt að 1 af hverjum 1.000 einstaklingum): • ofsakláði
English: • Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours.
Icelandic: Meðferð við blóðkalsíumhækkun vegna æxla - bætt út í 500 ml af ísótónískri natríumklóríðlausn eða 500 ml af 5% dextrósalausn og gefið sem innrennsli á 2 klukkustundum
English: • hair loss
Icelandic: • húðútbrot
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Icelandic: Í forklínískum rannsóknum komu eiturverkanir einungis fram við skömmtun sem talin er vera það langt yfir hámarksskömmtun fyrir menn að litlu skipti fyrir klíníska notkun.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
Icelandic: Hjá flestum sjúklingum með alvarlega blóðkalsíumhækkun (albúmín-leiðrétt kalsíum í sermi* > 3 mmól/l eða > 12 mg/dl) eru 4 mg hæfileg í einn skammt.
English: Ibandronic acid Accord contains sodium
Icelandic: Ibandronic acid Accord inniheldur natríum
English: Ibandronic acid is only for use in postmenopausal women and must not be taken by women of child bearing potential.
Icelandic: Íbandrónsýra er aðeins ætluð til notkunar hjá konum eftir tíðahvörf og konur á barneignaraldri mega ekki nota lyfið.
English: Very rare (may affect up to 1 in 10000 people):
Icelandic: Mjög sjaldgæfar (geta haft áhrif á allt að 1 af hverjum 1.000 einstaklingum):
English: It is not known whether ibandronic acid is excreted in human milk.
Icelandic: Ekki er þekkt hvort íbandrónsýra skilst út í brjóstamjólk.
English: For this purpose the contents of the vial are to be used as follows: - Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least 15 minutes.
Icelandic: Til varnar gegn beinkvillum hjá sjúklingum með brjóstakrabbamein og meinvörp í beinumsetja í 100 ml af ísótónískri natríumklóríðlausn eða 100 ml af 5% dextrósalausn og gefa það sem innrennsli á a.m.k. 15 mínútum.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Icelandic: Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum um notkun lyfsins.
English: Do not use Ibandronic acid Accord
Icelandic: Ekki má nota Ibandronic acid Accord:
English: • fluid build up and swelling (‘“lymphoedema”')
Icelandic: • vökvasöfnun og þroti (sogæðabjúgur)
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy
Icelandic: Styrkur lyfs sem hamlar niðurbroti beina (aukin hætta með mjög öflugum efnasamböndum), íkomuleið (aukin hætta við lyfjagjöf í æð) og uppsafnaður skammtur af meðferð við niðurbroti beina
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at the lumbar spine of -2 to -5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Icelandic: 5 árum eftir tíðahvörf þeirra, sem höfðu steinefnaþéttni (BMD) í lendarhrygg sem var -2 til -5 staðalfrávikum undir meðaltali fyrir konur fyrir tíðahvörf (T-stig) í a.m.k.
English: • walking or other weight-bearing exercise
Icelandic: • liðverkir, liðbólga eða aðrir kvillar í liðum
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Icelandic: Hjá sjúklingum með miðlungi mikla skerðingu á nýrnastarfsemi (CLcr ≥30 og <50 ml/mín.) eða alvarlega skerðingu á nýrnastarfsemi (CLcr <30 ml/mín.)
English: Ibandronic acid solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Icelandic: Íbandrónsýru stungulyf, lausn, má ekki blanda með lausnum sem innihalda kalsíum eða öðrum lyfjum til lyfjagjafar í bláæð.
English: Treatment of tumour-induced hypercalcaemia with or without metastases.
Icelandic: Meðferðar á blóðkalsíumhækkun af völdum æxlis, með eða án meinvarpa 4.2 Skammtar og lyfjagjöf
English: Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder
Icelandic: Niðurgangur, uppköst, meltingartruflanir, sársauki í meltingarvegi, tannkvillar
English: One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
Icelandic: Eitt hettuglas með 6 ml af innrennslisþykkni, lausn inniheldur 6 mg af íbandrónsýru (sem natríummónóhýdrat).
English: What Ibandronic acid Accord contains
Icelandic: Ibandronic acid Accord inniheldur
English: Pharmacokinetics of ibandronic acid are similar in men and women.
Icelandic: Lyfjahvörf íbandrónsýru eru svipuð hjá körlum og konum.
English: Ibandronic acid Accord 2 mg and 6 mg concentrate for solution for infusion (for oncology indications)
Icelandic: Ibandronic acid Accord 2 mg og 6 mg innrennslisþykkni, lausn (vegna ábendinga fyrir æxli) Ávísun lyfsins er háð sérstökum takmörkunum (sjá viðauka I:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
Icelandic: Hvert hettuglas inniheldur 2 mg af íbandrónsýru (sem natríum mónóhýdrat).
English: BMD - mean change relative to baseline lumbar spine at year 3
Icelandic: Steinefnaþéttni í beinummeðalbreyting í hlutfalli við grunnlínu lendarhryggjarliða á 3. ári
English: METHOD OF ADMINISTRATION EXPIRY DATE
Icelandic: 3. FYRNINGARDAGSETNING EXP
English: EXP: Read the package leaflet for the shelf life after dilution.
Icelandic: Lesið fylgiseðilinn hvað varðar geymslutíma eftir þynningu.
English: Gastritis, Dyspepsia, Diarrhoea, Abdominal pain, Nausea, Constipation
Icelandic: Magabólga, meltingartruflanir, niðurgangur, kviðverkur, ógleði, hægðatregða
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease an adjustment in the dose is recommended (see section 4.2).
Icelandic: eða alvarlega skerðingu á nýrnastarfsemi (CLcr <30 ml/mín.) sem eru á forvarnarmeðferð við beinkvillum og eru með brjóstakrabbamein og meinvörp í beinum er skammtaaðlögun ráðlögð (sjá kafla 4.2).
English: No specific information is available on the treatment of overdosage with ibandronic acid injection.
Icelandic: Ekki eru fyrirliggjandi neinar sértækar upplýsingar varðandi meðferð við ofskömmtun vegna inndælingar íbandrónsýru.
English: Appropriate medical support and monitoring measures should be readily available when ibandronic acid intravenous injection is administered.
Icelandic: Viðeigandi læknisaðstoð og eftirlitsbúnaður á að vera tiltækur þegar íbandrónsýra er gefin í bláæð.
English: Ibandronic acid concentrate for solution for infusion should not be mixed with calcium containing solutions.
Icelandic: Íbandrónsýru innrennslisþykkni, lausn á ekki að blanda lausnum sem innihalda kalsíum.
English: • it is given as an infusion into your vein.
Icelandic: lyfið er gefið sem innrennsli í æð
English: • The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.
Icelandic: Önnur innihaldsefni eru natríumklóríð, ediksýra, natríumacetat þríhýdrat og vatn fyrir stungulyf.
English: Incidence of clinical vertebral fracture
Icelandic: Meðferð við blóðkalsíumhækkun af völdum æxlis
English: 2 mg 4 mg 6 mg For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Icelandic: Miðgildi tímans sem það tók að ná kalsíum í blóði niður í eðlileg gildi hjá þessum sjúklingum við þessa skammta var 4-7 dagar.
English: Ibandronic acid should not be used during breastfeeding.
Icelandic: Íbandrónsýru á ekki að nota meðan á brjóstagjöf stendur.
English: Ocular inflammatio
Icelandic: Ónæmiskerfi
English: * Note albumin-corrected serum calcium concentrations are calculated as follows: Albumin-corrected serum calcium (mmol/l)
Icelandic: Albúmín-leiðrétt kalsíum í sermi (mmól/l)
English: Biochemical markers of bone turn-over
Icelandic: Lífefnafræðileg merki umsetningar beina
English: Care must be taken not to administer ibandronic acid injection via intra-arterial or paravenous administration as this could lead to tissue damage.
Icelandic: Gæta verður þess að gefa ekki íbandrónsýru með inndælingu í slagæð eða utan æðar þar sem það getur leitt til vefjaskemmda.
English: Existing hypocalcaemia must be corrected before starting ibandronic acid injection therapy.
Icelandic: Rétta verður blóðkalsíumlækkun sem fyrir er áður en meðferð með inndælingu íbandrónsýru hefst.
English: It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Icelandic: Það fæst í hettuglösum úr gleri (af gerð I) með gúmmítappa og álinnsigli með smelluloki.
English: Cases of ONJ have been reported in the post marketing setting for ibandronic acid.
Icelandic: Einnig hefur verið tilkynnt um tilvik beindreps í kjálka eftir markaðssetningu íbandrónsýru.
English: • eating a balanced diet rich in calcium and vitamin D
Icelandic: neyslu alhliða kalk- og D-vítamínríkrar fæðu
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonates, ATC code: M05BA06
Icelandic: Lyf við sjúkdómum í beinum, bisfosfónöt, ATC flokkur:
English: For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dose adjustment is necessary.
Icelandic: Ekki er þörf á skammtaaðlögun hjá sjúklingum með væga skerðingu á nýrnastarfsemi (CLcr ≥50 og <80 ml/mín.).
English: One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as sodium monohydrate).
Icelandic: Ein áfyllt sprauta með 3 ml af lausn inniheldur 3 mg af íbandrónsýru (sem natríum einhýdrat).
English: Ibandronic acid dose
Icelandic: á Ibandronic acid Accord
English: Prevention of skeletal events in patients with breast cancer and bone metastases
Icelandic: Til varnar beinkvillum hjá sjúklingum með brjóstakrabbamein og meinvörp í beinum
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Icelandic: Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hettuglasi, þ.e.a.s. er nær natríumlaust.
English: 6 ml, glass vial (type I) with ethylene tetrafluoroethylene rubber stopper and aluminium seals with lavender flip-off cap.
Icelandic: 6 ml hettuglas úr gleri (af gerð I) með etýlen tetraflúoróetýlen gúmmítappa og álinnsigli með fjólubláu smelluloki.
English: • a family history of osteoporosis
Icelandic: fjölskyldusaga um beinþynningu
English: Common (may affect upto 1 in 10 people)
Icelandic: Algengar (geta komið fram hjá allt að 1 af hverjum 10 einstaklingum)
English: Ibandronic acid should not be used during breast-feeding.
Icelandic: Íbandrónsýru á ekki að nota á meðan á brjóstagjöf stendur.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Icelandic: Ein áfyllt sprauta með 3 ml af lausn inniheldur 3 mg íbandrónsýru (sem natríum einhýdrat).
English: **See further information below †Identified in post-marketing experience.
Icelandic: *Sjá nánari upplýsingar fyrir neðan.
English: To avoid potential incompatibilities Ibandronic acid concentrate for solution for infusion should only be diluted with isotonic sodium chloride solution or 5% glucose solution.
Icelandic: Til þess að komast hjá hugsanlegum ósamrýmanleika á eingöngu að þynna íbandrónsýru innrennslisþykkni, lausn með ísótónískri natríumklóríðlausn eða 5% glúkósalausn.
English: PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless solution.
Icelandic: 3. LYFJAFORM Stungulyf, lausn (inndæling).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate).
Icelandic: Eitt hettuglas með 2 ml af innrennslisþykkni, lausn inniheldur 2 mg af íbandrónsýru (sem natríummónóhýdrat).
English: Daily oral treatment with ibandronic acid 2.5 mg tablets resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Icelandic: Dagleg meðferð með íbandrónsýru 2,5 mg töflum til inntöku olli stigvaxandi aukningu á beinasteinefnaþéttni hryggjarliða og annarra beina.
English: How to receive Ibandronic Acid Accord
Icelandic: 3. Hvernig nota á Ibandronic acid Accord
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Icelandic: Ibandronic acid Accord 6 mg innrennslisþykkni, lausn íbandrónsýra
English: The deterioration in Quality of Life was significantly less in ibandronic acid treated patients compared with placebo.
Icelandic: Minnkun á lífsgæðum var marktækt minni hjá sjúklingum sem fengu íbandrónsýru borið saman við lyfleysu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Virkniniðurstöður koma fram í töflu
English: Other disturbances of bone and mineral metabolism should also be effectively treated before starting ibandronic acid injection therapy.
Icelandic: Einnig þarf að ná árangri við meðhöndlun annarra truflana á umbroti beina og steinefna áður en meðferð með inndælingu íbandrónsýru hefst.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid
Icelandic: Ibandronic acid Accord 2 mg innrennslisþykkni, lausn íbandrónsýra
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.
Icelandic: Ibrandonic acid Accord innrennslisþykkni, lausn, á að gefa sem innrennsli í æð.
English: Ibandronic acid Accord 3 mg injection Ibandronic acid
Icelandic: Ibandronic acid Accord 3 mg stungulyf íbandrónsýra i.v. notkun