FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexdor should be administered by healthcare professionals skilled in the management of patients requiring intensive care.
Icelandic: Gjöf Dexdor á að vera í höndum heilbrigðisstarfsfólks sem hefur fengið þjálfun í meðferð gjörgæslusjúklinga.
English: In isolated cases bradycardia has progressed to periods of asystole in patients with pre-existing bradycardia.
Icelandic: Einstaka tilvik hægsláttar hafa þróast í rafleysu (asystole) hjá sjúklingum sem voru fyrir með hægslátt.
English: Dexdor must be administered only as a diluted intravenous infusion using a controlled infusion device.
Icelandic: Dexdor má aðeins gefa eftir þynningu með innrennsli í bláæð með vottuðum innrennslisbúnaði.
English: Plasma pharmacokinetics of dexmedetomidine is similar in the ICU population following infusion >24 h. The estimated pharmacokinetic parameters are: t1/2 approximately 1.5 hours, Vss approximately 93 litres and Cl approximately 43 l/h.
Icelandic: Áætluð gildi fyrir lyfjahvörf dexmedetomidíns eru: t1/2 u.þ.b. 1,5 klst., Vss u.þ.b. 93 lítrar og Cl u.þ.b. 43 l/klst.
English: Maintenance of Procedural Sedation:
Icelandic: - Viðhald slævingar við aðgerð:
English: Sedation of adult ICU (Intensive Care Unit) patients
Icelandic: Slæving fullorðinna sjúklinga á gjörgæslu
English: The oxygen saturation should be monitored by pulse oximetry.
Icelandic: Viðbótarsúrefni skal vera til staðar og gefið ef við á. Fylgjast skal með súrefnismettun með púlssúrefnismæli.
English: The risk difference in proportion of subjects randomised to dexmedetomidine not requiring rescue midazolam was 43% (95% CI: 23 % - 57%) compared placebo.
Icelandic: Áhættumunur hjá þeim sem var slembiraðað og fengu dexmedetomidín en þurftu ekki á midazolam neyðarlyfi að halda var 43% (95% CI:
English: Withdrawal syndrome, hyperthermia Uncommon: Drug ineffective, thirst
Icelandic: Fráhvarfseinkenni, ofurhiti (hyperthermia)
English: The observed exposure levels in the rat are below the clinical exposure range.
Icelandic: Mörk útsetningar hjá rottunum eru lægri en klínísk mörk útsetningar.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
Icelandic: Hvert 10 ml hettuglas inniheldur 1.000 míkrógrömm dexmedetomidín.
English: Dexmedetomidine exhibits a two-compartment disposition model.
Icelandic: Dexmedetomidín fylgir tveggja hólfa líkani.
English: Duration
Icelandic: Óróleiki
English: Hrvatska Malta România Orion Oyj
Icelandic: Orion Oyj
English: Your doctor will decide on a suitable dose for you.
Icelandic: Læknirinn ákveður hentugan skammt.
English: What Dexdor looks like and contents of the pack
Icelandic: Dexdor og pakkningastærðir
English: A decision must be made whether to discontinue breastfeeding or to discontinue dexmedetomidine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta meðferð með dexmedetomidíni.
English: - Hypotension (55 % in dexmedetomidine-group vs. 30 % in placebo-group receiving rescue midazolam and fentanyl) - Respiratory depression ( 38 % in dexmedetomidine-group vs. 35 % in placebo-group receiving rescue midazolam and fentanyl) - Bradycardia (14 % in dexmedetomidine-group vs. 4 % in placebo-group receiving rescue midazolam and fentanyl)
Icelandic: - Lágþrýstingur (55% í hópnum sem fékk dexmedetomidín samanborið við 30% í lyfleysuhópnum sem fékk neyðarlyfin midazolam og fentanyl)
English: Polyuria
Icelandic: Hrvatska
English: Care should be taken in severe hepatic impairment as excessive dosing may increase the risk of adverse reactions, over-sedation or prolonged effect as a result of reduced dexmedetomidine clearance.
Icelandic: Gæta á varúðar þegar um verulega skerta lifrarstarfsemi er að ræða þar sem minni blóðhreinsun getur valdið því að skammtur lyfsins verði of stór en það eykur hættu á aukaverkunum, of mikilli slævingu eða langvarandi áhrifum.
English: Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
Icelandic: Hvert 10 ml hettuglas inniheldur 1.000 míkrógrömm dexmedetomidín (sem hýdróklóríð).
English: After dose adjustment, a new steady state sedation level may not be reached for up to one hour.
Icelandic: Eftir breytingu skammta getur það tekið allt að 1 klst.
English: Total volume of infusion
Icelandic: Heildarmagn innrennslislausnar
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Icelandic: Hvert 4 ml hettuglas inniheldur 400 míkrógrömm dexmedetomidín (sem hýdróklóríð).
English: Reduced fetal body weight was noted also in the rat fertility study at dose 18 µg/kg/day and was accompanied with delayed ossification at dose 54 µg/kg/day.
Icelandic: 18 míkrógrömm/kg/sólarhring og því fylgdi seinkuð beingerð í skömmtum 54 míkrógrömm/kg/sólarhring.
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Icelandic: Hvert 4 ml hettuglas inniheldur 400 míkrógrömm dexmedetomidín.
English: Table 1.
Icelandic: Hægsláttur1,2
English: After sedation/wake-up
Icelandic: Slæving við aðgerðir/vakandi slæving
English: Sedation of adult ICU (Intensive Care Unit) patients The most frequently reported adverse reactions with dexmedetomidine in ICU setting are hypotension, hypertension and bradycardia, occurring in approximately 25%, 15% and 13% of patients respectively.
Icelandic: Algengustu aukaverkanir dexmedetomidíns sem greint hefur verið frá eftir notkun innan gjörgæslu eru lágþrýstingur sem kemur fram hjá u.þ.b. 25% sjúklinga, háþrýstingur hjá u.þ.b.
English: Caution should be exercised when administering dexmedetomidine to patients with pre-existing bradycardia.
Icelandic: Gæta skal varúðar þegar dexmedetomidín er gefið sjúklingum með hægslátt.
English: Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexdor should be used cautiously:
Icelandic: Dexdor ef eitthvað af neðantöldu á við, áður en þú færð lyfið skaltu láta lækninn eða hjúkrunarfræðing vita:
English: Uncontrolled hypotension.
Icelandic: Lágþrýstingur sem ekki næst stjórn á.
English: Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Icelandic: Dextor á að skoða með tilliti til agna og mislitunar fyrir lyfjagjöf.
English: Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Icelandic: Hver ml af þykkni inniheldur dexmedetomidín hýdróklóríð sem jafngildir 100 míkrógrömmum af dexmedetomidíni
English: Adverse reactions Metabolism and nutrition disorders Common:
Icelandic: Tafla 1. Aukaverkanir Efnaskipti og næring Algengar:
English: It must be administered only as a diluted intravenous infusion using a controlled infusion device
Icelandic: Lyfið má aðeins gefa eftir þynningu með innrennsli í bláæð með vottuðum innrennslisbúnaði.
English: Studies from outside the ICU have confirmed that Dexdor can be administered safely to patients without endotracheal intubation provided adequate monitoring is in place.
Icelandic: Dexdor án barkaþræðingar á öruggan máta ef nægjanlegt eftirlit er tryggt.
English: In placebo controlled trials in a post-operative ICU population previously intubated and sedated with midazolam or propofol, Dexdor significantly reduced the requirement for both rescue sedative
Icelandic: Í samanburðarrannsóknum með lyfleysu hjá sjúklingum á gjörgæsludeild, sem höfðu gengist undir aðgerð, verið barkaþræddir og slævðir með midazolam eða propofoli, dró Dexdor marktækt úr þörf fyrir slævandi lyfi til viðbótar (midazolam eða propofoli) og ópíóíðum meðan á allt að 24 klst. slævingu stóð.
English: Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
Icelandic: Hver 2 ml lykja inniheldur 200 míkrógrömm dexmedetomidín (sem hýdróklóríð).
English: In approximately 50% of cases, positive dechallenges were reported.
Icelandic: Í um það bil 50% tilvikanna var greint frá því að aukaverkunin gekk til baka þegar meðferð var hætt.
English: IV
Icelandic: Lda
English: A single case of hypothermic bradycardia in a neonate has been reported in the literature.
Icelandic: Í gögnum hefur verið greint frá einu tilviki hægsláttar vegna lækkunar líkamshita hjá nýbura.
English: Respiratory, thoracic and mediastinal disorders Very common: Respiratory depression2,3
Icelandic: Öndunarfæri, brjósthol og miðmæti Mjög algengar:
English: Alertness/Sedation Scale ≤4) without need for rescue midazolam was 54% of the patients receiving dexmedetomidine 1 µg/kg and 40% of the patients receiving dexmedetomidine 0.5 µg/kg compared to 3% of patients receiving the placebo.The risk difference in proportion of subjects randomised to dexmedetomidine 1 μg/kg group and dexmedetomidine 0.5 μg/kg group not requiring rescue midazolam was 48% (95% CI: 37 % - 57%) and 40% (95% CI: 28 % - 48%), respectively compared placebo.
Icelandic: Hlutfall sjúklinga, sem náði markgildi slævingar (≤ 4 á kvarða vöku/slævingar að mati áhorfanda, Observer's Assessment of Alertness/Sedation), án þess að þyrfti að nota midazolam sem neyðarlyf, var 54% af sjúklingunum sem fengu dexmedetomidín 1 µg/kg og 40% af sjúklingunum sem fengu dexmedetomidín 0,5 µg/kg borið saman við 3% af sjúklingum sem fengu lyfleysu.
English: Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Icelandic: Hver 2 ml lykja inniheldur 200 míkrógrömm dexmedetomidín.
English: Volume of diluent
Icelandic: Magn þynningarlausnar
English: 5 x 2 ml ampoules 25 x 2 ml ampoules 5 x 2 ml vials 4 x 4 ml vials 4 x 10 ml vials
Icelandic: 5 x 2 ml hettuglös
English: Dose reduction or discontinuation should be considered in a patient developing signs of myocardial or cerebral ischaemia.
Icelandic: Hugsanlega þarf að minnka skammta eða hætta meðferð hjá sjúklingum sem fá blóðþurrðareinkenni í hjarta eða heila.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Dexdor 100 micrograms/ml sterile concentrate dexmedetomidine
Icelandic: Dexdor 100 míkrógrömm/ml sæft þykkni dexmedetomidín i.v.
English: and -2.7 mg (95% CI: -3.3 - -2.1), respectively favouring dexmedetomidine.The median time to first rescue dose was 114 minutes in the dexmedetomidine 1.0 µg/kg group, 40 minutes in the dexmedetomidine 0.5 µg/kg group, and 20 minutes in the placebo group.
Icelandic: 114 mínútur hjá hópnum sem fékk dexmedetomidín 1,0 µg/kg, 40 mínútur hjá hópnum sem fékk dexmedetomidín 0,5 µg/kg og 20 mínútur hjá hópnum sem fékk lyfleysu.
English: Dexdor 100 micrograms/ml concentrate for solution for infusion
Icelandic: Dexdor 100 míkrógrömm/ml innrennslisþykkni, lausn
English: t1/2 (h)
Icelandic: VIRK(T) EFNI
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Icelandic: Hvert 2 ml hettuglas inniheldur 200 míkrógrömm dexmedetomidín (sem hýdróklóríð).
English: Some patients receiving Dexdor have been observed to be arousable and alert when stimulated.
Icelandic: Komið hefur í ljós að suma sjúklinga er auðvelt að vekja og eru vakandi við örvun.
English: Pregnancy
Icelandic: Umbrotsefni
English: Psychiatric disorders Common:
Icelandic: Meltingarfæri Algengar:
English: Volume of Dexdor 100 micrograms/ml concentrate for solution for infusion
Icelandic: Magn Dexdor 100 míkrógrömm/ml innrennslisþykkni, lausn
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Icelandic: Hvert 2 ml hettuglas inniheldur 200 míkrógrömm dexmedetomidín.
English: Dexmedetomidine has analgesic and anaesthetic/analgesic-sparing effects.
Icelandic: Dexmedetomidín hefur verkjastillandi áhrif og dregur úr þörf fyrir notkun svefn- og verkjalyfja.
English: Dexdor should be administered only by health care professionals skilled in the anaesthetic management of patients in the operating room or during diagnostic procedures.
Icelandic: Aðeins heilbrigðisstarfsfólk sem er sérhæft í að hafa umsjón með deyfingu/svæfingu sjúklinga innan skurðstofunnar eða meðan á sjúkdómsgreiningaraðgerð stendur má gefa Dexdor.
English: The adverse drug reaction (ADR) of hyperthermia is already highlighted in the Summary of Product Characteristics (SmPCs) therefore is subject to routine pharmacovigilance and routine risk minimisation, however the current warning in section 4.4 of the SmPC does not mention the lack of effect of cooling through other measures.
Icelandic: Nú þegar hefur verið lögð áhersla á aukaverkunina ofurhita í samantekt á eiginleikum lyfsins (SmPC) og er því hluti venjubundinnar lyfjagátar og aðgerða til að lágmarka áhættu.
English: Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
Icelandic: Dexdor er þynnt og gefið með innrennsli (dreypi) í bláæð.
English: Batch
Icelandic: Dexdor
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Orion Corporation
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt
English: Containers
Icelandic: Pakkningastærðir
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 September 2011
Icelandic: Á yfirstandandi skýrslutímabili 16. mars 2017
English: Orionintie 1
Icelandic: Orionfin
English: This is called overgrowth.
Icelandic: Þetta er kallað yfirvöxtur.
English: Eesti filiaal
Icelandic: Eesti filial
English: - The treatment course usually lasts 5 to 14 days.
Icelandic: - Meðferðarlotan stendur yfirleitt í 5-14 daga.
English: Infusion time a, b
Icelandic: Innrennslistími a,b
English: The first two numbers indicate the month.
Icelandic: Fyrstu tveir stafirnir tákna mánuðinn.
English: The next four numbers indicate the year.
Icelandic: Næstu fjórir stafir tákna árið.
English: Date of first authorisation: 25 July 2008
Icelandic: 25. júlí 2008
English: 72 hours*
Icelandic: 72 klst.*
English: Elderly patients ( 65 years of age)
Icelandic: Aldraðir ( 65 ára)
English: Each dose is given over a period of one or four
Icelandic: Hver skammtur er gefinn á einni eða fjórum
English: Solution stored in a refrigerator (2C-8C)
Icelandic: Lausn geymd í kæli (2C-8C)
English: Your doctor will monitor you for overgrowth and treat you if necessary.
Icelandic: Læknirinn mun fylgjast með yfirvexti og veita meðferð ef þörf krefur.
English: Remove 55 ml of this solution from the infusion bag and discard.
Icelandic: Takið 55 ml af þessari lausn úr innrennslispokanum og fargið.
English: Target attainment (MIC)
Icelandic: Markmið (MIC)
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3.
Icelandic: Ekki má blanda þessu lyfi saman við önnur lyf en þau sem nefnd eru í kafla 6.3.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Icelandic: Viðmið lágmarksheftistyrks (MIC), sem eru ákvörðuð af „European Committee on Antimicrobial Susceptibility Testing“ (EUCAST), eru eftirfarandi:
English: Small amounts of this medicine may pass into breast milk and it may affect the baby.
Icelandic: Þetta lyf getur borist í litlu magni yfir í brjóstamjólk og það getur haft áhrif á barnið.
English: These changes were mainly attributed to age-related changes in renal function.
Icelandic: Breytingarnar voru aðallega tengdar aldursháðum breytingum á nýrnastarfsemi.
English: Patients should be carefully monitored during therapy.
Icelandic: Fylgjast skal vandlega með sjúklingum meðan á meðferð stendur.
English: It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.
Icelandic: Það er mikilvægt að þú fáir meðferð með Doribax eins lengi og læknirinn telur þörf á.
English: In vitro studies have determined that doripenem does not inhibit or induce the activities of CYP isoforms 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 or 3A4.
Icelandic: Í in vitro rannsóknum hefur verið sýnt fram á að doripenem hemur hvorki né hvetur virkni CYP ísóensímanna 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 eða 3A4.
English: OTHER SPECIAL WARNING (S) IF NECESSARY
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF
English: This dosing regimen should also be considered in particularly severe
Icelandic: Þessa meðferð ætti einnig að íhuga gegn sérstaklega alvarlegum sýkingum.
English: In addition, the patients were allowed to receive specified adjunctive therapies.
Icelandic: Auk þess máttu sjúklingar þiggja sérhæfða viðbótarmeðferð.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Icelandic: Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu.
English: Doribax was discontinued because of adverse drug reactions in 0.1% of patients overall.
Icelandic: Gjöf Doribax var hætt vegna lyfjatengdra aukaverkana hjá 0,1% allra sjúklinga.
English: No reproductive toxicity was observed in studies performed in rats and rabbits.
Icelandic: Ekki komu fram neinar eiturverkanir á æxlun í rannsóknum á rottum og kanínum.
English: Doribax should not be given to children or adolescents (under 18 years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.
Icelandic: Doribax á ekki að nota handa börnum og unglingum (yngri en 18 ára) þar sem ekki liggja fyrir nægar upplýsingar um öryggi við notkun Doribax hjá þessum aldurshópum.
English: other than S. pneumoniae
Icelandic: S. pneumoniae
English: Therefore, no CYP450-related drug interactions are to be expected (see section 5.2).
Icelandic: Þess vegna er ekki búist við neinum lyfjamilliverkunum tengdum CYP450 (sjá kafla 5.2).
English: The clinical consequences of such an increase in exposure are unknown.
Icelandic: Klínískar afleiðingar slíkrar aukningar á útsetningu eru óþekktar.
English: Doribax is supplied in packs of 10 vials.
Icelandic: Doribax er fáanlegt í pakkningu með 10 hettuglösum.
English: Bacteroides fragilis Bacteroides caccae Bacteroides ovatus Bacteroides uniformis Bacteroides thetaiotaomicron Bacteroides vulgatus Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros Porphyromonas spp.
Icelandic: Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas-tegundir Prevotella-tegundir Sutterella wadsworthensis
English: The safety and efficacy of Doribax in children aged less than 18 years have not yet been established.
Icelandic: Ekki hefur enn verið sýnt fram á öryggi og verkun hjá börnum yngri en 18 ára.
English: Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established.
Icelandic: Doripenem var gefið í allt að 14 daga í klínískum rannsóknum og ekki hefur verið sýnt fram á öryggi lengri meðferðartímabila.
English: (see sections 4.2 and 5.1).
Icelandic: -1 (sjá kafla 4.4 og 5.2).
English: The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to doripenem or not.
Icelandic: Upplýsingarnar hér fyrir neðan eru aðeins leiðbeinandi varðandi líkur á því hvort örvera muni vera næm fyrir doripenemi eða ekki.
English: The impact of age on the pharmacokinetics of doripenem was evaluated in healthy elderly male and female subjects (66-84 years of age).
Icelandic: Áhrif aldurs á lyfjahvörf doripenems voru metin hjá heilbrigðum öldruðum körlum og konum (á aldrinum 66-84 ára).
English: filiāle Latvijā
Icelandic: Z.o.o. filiāle Latvijā
English: Do not take any medicine to treat diarrhoea without first checking with your doctor.
Icelandic: Þú skalt ekki taka nein lyf við niðurganginum án þess að ráðfæra þig fyrst við lækninn.
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
Icelandic: Þetta geta verið einkenni alvarlegra ofnæmisviðbragða (bráðaofnæmi) og geta verið lífshættuleg.
English: Doribax is reconstituted and then further diluted prior to infusion.
Icelandic: Doribax er leyst upp og síðan þynnt frekar fyrir inndælingu.
English: CRRT: continuous renal replacement therapy; CVVH: continuous venovenous haemofiltration; CVVHDF: continuous venovenous haemodiafiltration; MIC: minimum inhibitory concentration
Icelandic: CRRT: samfelld skilunarmeðferð (continuous renal replacement therapy); CVVH: samfelld bláæðar-bláæðar blóðskilun (continuous venovenous haemofiltration); CVVHDF: samfelld bláæðar-bláæðar blóðskilun ogsíun (continuous venovenous haemodiafiltration); MIC: lágmarksheftistyrkur
English: Name and address of the manufacturer(s) responsible for batch release Janssen Pharmaceutica NV
Icelandic: Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt Janssen Pharmaceutica NV
English: The rash resolved within 10 days after doripenem administration was discontinued.
Icelandic: Útbrotin hurfu innan 10 daga eftir að gjöf doripenems var hætt.
English: Before therapy with Doribax is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics.
Icelandic: Áður en meðferð með Doribax er hafin skal rannsaka vandlega fyrri sögu um ofnæmisviðbrögð við öðrum virkum efnum í þessum flokki eða beta-laktam sýklalyfjum.
English: Doripenem AUC increased 49% in elderly adults relative to young adults.
Icelandic: AUC doripenems jókst um 49% samanborið við hjá yngri fullorðnum.
English: Your doctor may need to lower your dose of Doribax.
Icelandic: Læknirinn gæti þurft að minnka skammtinn af Doribax. - niðurgang.
English: This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Icelandic: Lyfið er sýklalyf sem drepur ýmsar tegundir af bakteríum sem valda sýkingum í ýmsum hlutum líkamans.
English: Doripenem AUC was 13% higher in females compared to males.
Icelandic: AUC gildi doripenems var 13% hærra hjá konum en körlum.
English: The most common adverse reactions were headache (10%), diarrhoea (9%) and nausea (8%).
Icelandic: Algengustu aukaverkanirnar voru höfuðverkur (10%), niðurgangur (9%) og ógleði (8%).
English: While antibiotics including Doribax kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Icelandic: Þó svo að sýklalyf, þar með talið Doribax, drepi ákveðnar bakteríur geta aðrar bakteríur og sveppir náð að fjölga sér hraðar en venjulega.
English: This includes medicines you get without a prescription or herbal medicines.
Icelandic: Þetta á einnig við um lyf sem fengin eru án lyfseðils sem og náttúrulyf.
English: Additive activity or weak synergy with amikacin and levofloxacin has been seen for Pseudomonas aeruginosa and for gram-positive bacteria with daptomycin, linezolid, levofloxacin, and
Icelandic: Samlagningarvirkni eða væg samverkun með amikacini og levofloxacini hefur sést hjá Pseudomonas aeruginosa og hjá Gram-jákvæðum bakteríum með daptomycini, linezolidi, levofloxacini og
English: - Complicated infections of the area around your stomach (abdominal infections).
Icelandic: - Erfiðum sýkingum í svæðinu í kringum magann (sýkingum í kviðarholi).
English: Doripenem is a synthetic carbapenem antibacterial agent.
Icelandic: Doripenem er samtengt karbapenem sýklalyf.
English: Doripenem-M-1 had a slow elimination in the patient group and the half-life (and AUC) has not been satisfactorily determined.
Icelandic: -1 var hægt hjá sjúklingahópnum og helmingunartíminn (og AUC) hefur ekki verið ákvarðaður á fullnægjandi hátt.
English: What Doribax is and what it is used for
Icelandic: Upplýsingar um Doribax og við hverju það er notað
English: Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of 1 or 4 hours.
Icelandic: Leysa skal Doribax upp og síðan skal það þynnt (sjá kafla 6.6) áður en það er gefið með innrennsli í bláæð í 1 eða 4 klst.
English: sodium chloride 9 mg/ml (0.9%) solution for injection
Icelandic: natríumklóríðlausn 9 mg/ml (0,9%) til inndælingar