FrancophonIA/ELRC3.0 huggingface dataset:
English: The product should be administered using a suitable measuring device with appropriate graduations (e.g. automatic pipette, disposable syringe) onto the bees sitting in seams.
Icelandic: Lyfið skal gefa með hentugu mælitæki með viðeigandi kvörðum (t.d. sjálfvirkri pípettu, einnota sprautu) á býflugur sem sitja í röndum.
English: 1 ml of mixed bee-hive dispersion contains:
Icelandic: 1 ml af blandaðri býbúsördreifu inniheldur:
English: Oxybee should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Icelandic: Oxybee má ekki berast í vötn, ár eða læki þar sem það kann að vera skaðlegt fiski eða öðrum vatnalífverum.
English: One sachet of 125 g of powder contains:
Icelandic: Einn skammtapoki með 125 g af dufti inniheldur:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (for powder and solution for bee-hive dispersion)
Icelandic: YTRI UMBÚÐUM Pappaaskja (fyrir duft og lausn fyrir býbúsördreifu fyrir hunangsbý)
English: The overdose did not significantly affect the development of the colonies in the long term, as shown by the development of the colonies in spring.
Icelandic: Ofskömmtunin hafði ekki veruleg áhrif á þróun býbúa til lengri tíma, eins og kom fram í þróun býbúanna að vori.
English: The final bee-hive dispersion should be a colourless, clear to slightly turbid dispersion.
Icelandic: Fullbúna býbúsördreifan ætti að vera litlaus, tær til svolítið gruggug dreifa.
English: No MRL required
Icelandic: Býflugur MRL (hámarksgildi lyfjaleifa) ekki krafist
English: Advice on correct administration:
Icelandic: Leiðbeiningar um rétta lyfjagjöf:
English: TARGET SPECIES Honey bees (Apis mellifera)
Icelandic: Hunangsbý (Apis mellifera)
English: One bottle of 750 g of solution contains:
Icelandic: Eitt glas með 750 g af lausn inniheldur:
English: Solution:
Icelandic: Lausn:
English: EU/2/17/216/002 (750 g g solution)
Icelandic: EU/2/17/216/002 (750 g lausn)
English: An overdose of 53% of the dispersion per treatment resulted in a temporary, short-term increase in bee mortality.
Icelandic: 53% ofskömmtun dreifunnar í hverri meðferð olli tímabundinni, skammvinnri aukningu í dánartíðni.
English: Oxalic acid dihydrate is externally distributed on the bees through body contact and/or social food exchange (trophallaxis).
Icelandic: Oxalsýrutvíhýdrat dreifist á yfirborði býflugna með líkamlegri snertingu og/eða við fæðuskipti (trophallaxis).
English: Personal protective equipment consisting of protective clothing, acid-proof gloves and safety glasses should be worn.
Icelandic: Nota skal hlífðarbúnað sem samanstendur af hlífðarfatnaði, sýruþolnum hönskum og öryggisgleraugum.
English: The full content of the sachet(s) should be poured into the bottle with the solution.
Icelandic: Öllu innihaldi pokans/pokanna skal hella ofan í glasið með lausninni.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One bottle of 375 g of solution contains:
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Eitt glas með 375 g af lausn inniheldur:
English: Shelf life after mixing according to directions: 1 year.
Icelandic: 2 ár Geymsluþol eftir blöndun samkvæmt leiðbeiningum:
English: The dispersion should be warm (30 - 35 °C) during application.
Icelandic: Dreifan skal vera volg (30-35°C) við notkun.
English: Pharmacotherapeutic group: Ectoparasiticides, insecticides and repellents; Ectoparasiticide for topical use, incl.
Icelandic: Lyf gegn útvortis sníkjudýrum, skordýraeitur og skordýrafælur; lyf gegn útvortis sníkjudýrum til útvortis notkunar, þ.m.t. skordýraeitur ATCvet flokkur:
English: SPECIAL STORAGE CONDITIONS Keep the bottle in the outer carton in order to protect from light.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið glasið í ytri öskjunni til varnar gegn ljósi.
English: The major contributor to the acaricidal effects is the low pH of the dispersion, as opposed to the volume of dispersion administered.
Icelandic: Aðalþáttur mítladrepandi áhrifanna er lágt pH dreifunnar, frekar en rúmmál dreifunnar sem notað er.
English: Keep the bottle and the sachet in the outer carton in order to protect from light.
Icelandic: Geymið glasið og skammtapokann í ytri öskjunni til varnar gegn ljósi.
English: High-density polyethylene (HDPE) bottle with an HDPE/ polypropylene (PP) child-proof screw cap containing 375 g or 750 g solution.
Icelandic: HDPE glas með HDPE/pólýprópýlen (PP) skrúfloki með barnaöryggi sem inniheldur 375 g eða 750 g af lausn.
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid)
Icelandic: Oxalsýrutvíhýdrat 39,4 mg (jafngildir 28,1 mg af oxalsýru)
English: The final bee-hive dispersion is to be trickled onto the bees in the seams.
Icelandic: Fullbúinni býbúsördreifu skal dreypa á býflugurnar í röndunum.
English: Sucrose 125 g
Icelandic: Súkrósi 125 g
English: SPECIAL STORAGE CONDITIONS Keep the bottle and the sachet in the outer carton in order to protect from light.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið glasið og skammtapokann í ytri öskjunni til varnar gegn ljósi.
English: Oxybee must only be applied only once in brood-free colonies.
Icelandic: Oxybee má aðeins nota einu sinni í búum án ungviðis.
English: Oxalic acid
Icelandic: Oxalsýra
English: A maximum dose of 5-6 ml of the final bee-hive dispersion should be administered once per seam occupied by bees.
Icelandic: Gefa skal að hámarki 5-6 ml skammt af fullbúinni býbúsördreifu einu sinni í hverja rönd (seam) af býflugum.
English: The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Icelandic: Dýralyfið má ekki berast í vötn, ár eða læki þar sem það kann að vera skaðlegt fiski eða öðrum vatnalífverum.
English: Four-layered foil (low-density polyethylene (LDPE)/ aluminium/ LDPE/ clay-coated paper) sealed sachets containing 125 g of flavoured sucrose.
Icelandic: Innsiglaðir skammtapokar úr fjögurra laga þynnu (LDPE/ál/LDPE/leirhúðaður pappír) sem innihalda 125 g af bragðbættum súkrósa.
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid) Colourless, clear to slightly turbid dispersion.
Icelandic: Oxalsýrutvíhýdrat 39,4 mg (jafngildir 28,1 mg af oxalsýru) Litlaus, tær til svolítið gruggug dreifa.
English: One bottle of 375 g solution contains:
Icelandic: Eitt glas með 375 g af lausn inniheldur:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001 (375 g g solution)
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/17/216/001 (375 g lausn)
English: Oxybee has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Icelandic: Oxybee er tærandi og getur haft áhrif á þá hluta búnaðs til býflugnaræktar sem viðkvæmir eru fyrir tæringu.
English: The veterinary medicinal product should be used as a treatment within an Integrated Varroa Management program with mite drop monitored regularly.
Icelandic: Dýralyfið skal nota sem þátt í heildrænni áætlun gegn varróaveiki ásamt reglulegu eftirliti með mítlafjölda í fallgildrum.
English: 17.5 g oxalic acid dihydrate (equivalent to 12.5 g of oxalic acid) (375 g solution) 35 g oxalic acid dihydrate (equivalent to 25.0 g of oxalic acid) (750 g solution)
Icelandic: 17,5 g oxalsýrutvíhýdrat (jafngildir 12,5 g af oxalsýru) (375 g lausn) 35 g oxalsýrutvíhýdrat (jafngildir 25 g af oxalsýru) (750 g lausn)
English: When possible, rotate the use of this product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Icelandic: Ef mögulegt er skal nota til skiptis þetta dýralyf og annan samþykktan varróaeyði með annan verkunarhátt til að minnka líkur á ónæmismyndun hjá varróamítlum.
English: After overdosing, increased bee mortality was very commonly observed.
Icelandic: Eftir ofskömmtun var mjög algengt að aukin dánartíðni kæmi fram hjá býflugum.
English: In-hive use.
Icelandic: Til notkunar í býbú.
English: Open the sachet(s) of the sucrose powder with a pair of scissors.
Icelandic: Opnið skammtapokann/pokana með súkrósaduftinu með skærum.
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid)
Icelandic: Oxalsýrutvíhýdrat 17,5 g (jafngildir 12,5 g af oxalsýru)
English: In clinical trials, increased bee mortality was very commonly observed.
Icelandic: Í klínískum rannsóknum var mjög algengt að aukin dánartíðni kæmi fram.
English: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid)
Icelandic: Oxalsýrutvíhýdrat 35,0 g (jafngildir 25,0 g af oxalsýru)
English: Powder and solution for bee-hive dispersion.
Icelandic: Duft og lausn fyrir býbúsördreifu.
English: insecticides
Icelandic: LYFJAFORM
English: After mixing the bee-hive dispersion: Store in a refrigerator (2 °C - 8 °C).
Icelandic: Geymið í kæli (2°C-8°C).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee solution for bee-hive dispersion oxalic acid dihydrate
Icelandic: HEITI DÝRALYFS Oxybee duft og lausn fyrir býbúsördreifu oxalsýrutvíhýdrat
English: PACKAGE LEAFLET:
Icelandic: Blöndun fullbúinnar dreifu:
English: Before use, the contents of the sachet(s) containing the flavoured sucrose powder should be added to the bottle containing the solution for bee-hive dispersion as follows:
Icelandic: Fyrir notkun skal bæta innihaldi skammtapokans/pokanna með bragðbætta súkrósaduftinu út í glasið sem inniheldur lausnina fyrir býbúsördreifuna á eftirfarandi hátt:
English: Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Icelandic: Oxybee duft og lausn fyrir 39,4 mg/ml býbúsördreifu fyrir hunangsbý
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid) Clear and colourless solution.
Icelandic: Oxalsýrutvíhýdrat 17,5 g (jafngildir 12,5 g af oxalsýru) Tær og litlaus lausn.
English: One cardboard box containing one 500 ml bottle (containing 375 g oxalic acid dihydrate solution) and one sachet (containing 125 g sucrose powder), providing 444 ml of the final bee-hive dispersion after mixing.
Icelandic: Ein pappaaskja sem inniheldur eitt 500 ml glas (sem inniheldur 375 g af oxalsýrutvíhýdratlausn) og einn skammtapoka (sem inniheldur 125 g af súkrósadufti), sem gefa 444 ml af fullbúinni býbúsördreifu.
English: One cardboard box containing one HDPE bottle (750 g) and two sachets (each containing 125 g) providing 888 ml final bee-hive dispersion after mixing.
Icelandic: Ein pappaaskja sem inniheldur eitt HDPE glas (750 g) og tvo skammtapoka (125 g hvor um sig), sem mynda 888 ml af fullbúinni býbúsördreifu eftir blöndun.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Icelandic: HEITI DÝRALYFS Oxybee duft og lausn fyrir 39,4 mg/ml býbúsördreifu fyrir hunangsbý
English: Solution for bee-hive dispersion (bottle containing the active substance): Clear and colourless solution.
Icelandic: Lausn fyrir býbúsördreifu (glas sem inniheldur virka efnið):
English: Avoid oral exposure, including hand-to-mouth contact.
Icelandic: Forðist inntöku, þ.m.t. að bera hönd að munni.
English: One cardboard box containing one HDPE bottle (375 g) and one sachet (125 g), providing 444 ml final bee-hive dispersion after mixing.
Icelandic: Ein pappaaskja sem inniheldur eitt HDPE glas (375 g) og einn skammtapoka (125 g), sem mynda 444 ml af fullbúinni býbúsördreifu eftir blöndun.
English: Apply only one treatment per hive.
Icelandic: Hvert býbú skal aðeins meðhöndla einu sinni.
English: 1 bottle with 375 g oxalic acid dihydrate solution and one sachet (125 g) of sucrose powder, to achieve 444 ml bee-hive dispersion after mixing with sucrose.
Icelandic: 1 glas með 375 g af oxalsýrutvíhýdratlausn og einn skammtapoki (125 g) af súkrósadufti til að útbúa 444 ml af býbúsördreifu eftir blöndun við súkrósa.
English: Preparation of the 888 ml final dispersion: Pour the content of the two sachets into the bottle containing 750 g of the oxalic acid oxalic dihydrate acid solution.
Icelandic: Hellið innihaldi tveggja skammtapoka ofan í glasið sem inniheldur 750 g af oxalsýrutvíhýdratlausninni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Icelandic: Oxybee duft og lausn fyrir 39,4 mg/ml býbúsördreifu oxalsýrutvíhýdrat
English: 1 bottle with 750 g oxalic acid dihydrate solution and two sachets (each containing 125 g) of sucrose powder to achieve 888 ml bee-hive dispersion after mixing with sucrose.
Icelandic: 1 glas með 750 g af oxalsýrutvíhýdratlausn og tveir skammtapokar (125 g hvor um sig) af súkrósadufti til að útbúa 888 ml af býbúsördreifu eftir blöndun við súkrósa.
English: No entry Antiinfectious agent
Icelandic: Engin færsla Sýklalyf
English: Preparation of the final bee-hive dispersion:
Icelandic: Fullbúin býbúsördreifa (eftir blöndun):
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/216/001-002
Icelandic: EU/2/17/216/001-002
English: Sachet:
Icelandic: Hunang:
English: Dose:
Icelandic: Förgun:
English: STATEMENT OF ACTIVE SUBSTANCES One bottle contains:
Icelandic: Eitt glas inniheldur:
English: 750 g oxalic acid dihydrate solution to achieve 888 ml bee-hive dispersion.
Icelandic: 375 g oxalsýrutvíhýdratlausn til að útbúa 444 ml af býbúsördreifu 750 g oxalsýrutvíhýdratlausn til að útbúa 888 ml af býbúsördreifu
English: Powder and solution for bee-hive dispersion
Icelandic: Oxybee duft og lausn fyrir býbúsördreifu súkrósi
English: CLINICAL PARTICULARS 4.1 Target species Honey bees (Apis mellifera)
Icelandic: DÝRATEGUND(IR) Hunangsbý (Apis mellifera)
English: Preparation of the 444 ml final bee-hive dispersion: Pour the content of one sachet into the bottle containing 375 g of the oxalic acid dihydrate acid solution.
Icelandic: Hellið innihaldi eins skammtapoka ofan í glasið sem inniheldur 375 g af oxalsýrutvíhýdratlausninni.
English: 125 g sucrose 250 g sucrose
Icelandic: 250 g súkrósi
English: WITHDRAWAL PERIOD(S) Honey: Zero days.
Icelandic: BIÐTÍMI FYRIR AFURÐANÝTINGU Hunang:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle
Icelandic: VIÐAUKI I SAMANTEKT Á EIGINLEIKUM LYFS
English: Citric acid monohydrate Glycerol (85%) Water, purified
Icelandic: Glýceról (85%)
English: Labelling
Icelandic: Merkingar
English: It is recommended not to drink alcohol while you're taking {product name}.
Icelandic: Mælt er með að drekka ekki áfengi meðan {heiti lyfs} er tekið.
English: Summary of Product Characteristics 4.4 Special warnings and precautions for use
Icelandic: 4.4 Sérstök varnaðarorð og varúðarreglur við notkun
English: Package Leaflet Section 2 - Before you take {product name}
Icelandic: Kafli 2 - Atriði sem huga þarf að áður en notkun á {heiti lyfs}hefst
English: Drinking alcohol whilst taking {product name} may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness.
Icelandic: Áfengisdrykkja meðan {heiti lyfs} er tekið getur aukið syfju eða magnað hættuna á alvarlegum aukaverkunum á borð við grunna öndun með hættu á öndunarstöðvun og meðvitundarleysi.
English: Applicable to all products except those containing a polymethacrylate-triethylcitrate coating as modified-release mechanism.
Icelandic: Á við um öll lyf nema þau er innihalda polýmetacrylat-tríetýlsítrat húðun fyrir breyttan losunarhraða.
English: For products not having warnings regarding the interaction with alcohol in the currently approved SPC and package leaflet, the below wording should be added.
Icelandic: Fyrir lyf sem ekki eru með viðvörun við notkun samtímis áfengisneyslu í núgildandi samþykkt SPD, skal bæta við eftirfarandi orðum.
English: For products having warnings regarding the interaction with alcohol, the existing wording in the SPC and package leaflet should be replaced by the wording below.
Icelandic: Fyrir lyf með viðvörunum við notkun samtímis áfengisneyslu, skal lýsingin hér á eftir koma í stað þeirrar lýsingar sem fyrir er í SPC og á fylgiseðlinum.
English: Concomitant use of alcohol and {product name} may increase the undesirable effects of {product name}; concomitant use should be avoided.
Icelandic: Samtímis notkun áfengis og {heiti lyfs} getur aukið aukaverkanir af völdum {heiti lyfs}; forðast skal samtímis notkun.
English: Alcohol may enhance the pharmacodynamic effects of {product name}; concomitant use should be avoided.
Icelandic: Áfengi getur aukið lyfhrif {heiti lyfs}; forðast skal samtímis notkun.
English: Any existing warnings on the interaction with alcohol should be deleted.
Icelandic: Eyða skal öllum fyrri viðvörunum við samtímis neyslu áfengis og notkun lyfja.
English: *number of divided doses dependant on advice from doctor.
Icelandic: *fjöldi skiptra skammta fer eftir ráðleggingum læknis.
English: The capsules can be taken with or without food.
Icelandic: Hylkin má taka með eða án matar.
English: Efficacy and safety was studied in two retrospective trials in two centres in Europe.
Icelandic: Verkun og öryggi var rannsakað í tveimur afturvirkum rannsóknum í tveimur setrum í Evrópu.
English: Liver function should also be monitored.
Icelandic: Einnig þarf að fylgjast með lifrarstarfsemi.
English: This medicine is for long-term use.
Icelandic: Lyfið er til langtímanotkunar.
English: Do not refrigerate or freeze.
Icelandic: Hana má ekki geyma í kæli eða láta frjósa.
English: Limited safety data are available (see section 4.8).
Icelandic: Takmarkaðar upplýsingar liggja fyrir um öryggi (sjá kafla 4.8).
English: Please speak to your doctor if you are taking any of these medicines.
Icelandic: Ræddu við lækninn þinn ef þú tekur eitthvert þessara lyfja.
English: Germany e-mail: info@leadiantbiosciences.com
Icelandic: Þýskaland netfang: info@leadiantbiosciences.com
English: Polígono Industrial Azque Alcalá de Henares Madrid 28806
Icelandic: Industrial Azque Alcalá de Henares Madrid 28806
English: The three adverse reactions were all nonserious.
Icelandic: Engin af aukaverkununum þremur var alvarleg.
English: If you stop taking this medicine your symptoms may worsen.
Icelandic: Ef þú hættir að nota lyfið geta einkenni þín versnað.
English: In babies and children the dose will be calculated from the child's weight.
Icelandic: Hjá ungbörnum og börnum er skammturinn reiknaður út frá þyngd barnsins.
English: Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps.
Icelandic: Gætið þess að skafa allt duft af hliðum skálarinnar ofan í blönduna og hrærið (í um 5 mínútur) til að ganga úr skugga um að engir kekkir séu í henni.
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Icelandic: Endurupptaka chenodeoxykólínsýru er breytileg (29-84%).
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnupakkningunni á eftir „EXP“.
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Icelandic: Læknirinn mun segja þér hve mörg hylki þú þarft að taka og hvenær þú átt að taka þau.
English: 80538 Munich
Icelandic: 80538 München
English: Side effects of unknown frequency (cannot be estimated from the available data)
Icelandic: Aukaverkanir með óþekkta tíðni (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture.
Icelandic: Læknirinn þinn eða lyfjafræðingur mun gefa þér leiðbeiningar um hversu oft barnið þarf að taka mixtúru og í hvaða magni.
English: Stir the mixture until all the powder is in suspension.
Icelandic: Hrærið blönduna þar til allt duftið er orðið að dreifu.
English: The mixture is ready when there are no visible lumps or powder.
Icelandic: Mixtúran er tilbúin þegar það eru engir sýnilegir kekkir eða duft.
English: Neonates less than one month of age
Icelandic: Nýburar yngri en eins mánaðar
English: The safety and efficacy in neonates less than one month of age has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun hjá börnum yngri en eins mánaðar.
English: Use in children (aged one month to 18 years)
Icelandic: Notkun hjá börnum (frá eins mánaða aldri til 18 ára)
English: Patients who are unable to swallow capsules
Icelandic: Sjúklingar sem ekki geta kyngt hylkjum
English: Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)
Icelandic: Hylkisskel: gelatín, títandíoxíð (E 171), kínólíngulur (E 104), erýtrósín (E 127)
English: The events were transitory and did not interfere with the therapy.
Icelandic: Um var að ræða skammvinna atburði sem trufluðu ekki meðferðina.
English: It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food.
Icelandic: Það er hluti af galli, vökva sem hjálpar líkamanum að melta fitu og vítamín úr mat.
English: The doctor will decide how many times and when your child should receive the dose(s) to make up the total dose for the day.
Icelandic: Læknirinn mun ákveða hversu oft og hvenær barnið á að fá skammtinn/skammtana til að ná upp í heildarskammtinn fyrir daginn.
English: The suspension is stable for up to 7 days.
Icelandic: Mixtúran er stöðug í allt að 7 daga.
English: Signs and symptoms of the disease remained stable in most of the patients.
Icelandic: Sjúkdómseinkenni voru stöðug hjá flestum sjúklingunum.
English: No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Icelandic: Engar formlegar forklínískar öryggisrannsóknir hafa verið gerðar en birt gögn benda ekki til neinnar sérstakrar hættu fyrir menn, á grundvelli hefðbundinna rannsókna á eiturverkunum eftir staka skammta, eiturverkunum eftir endurtekna skammta, eiturverkunum á erfðaefni, og krabbameinsvaldandi áhrifum.
English: 22 80538 Munich Germany
Icelandic: 22 80538 München Þýskaland
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Icelandic: Mjög algengar (≥1/10), algengar (≥1/100 til <1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: MedDRA System Organ Class Preferred term
Icelandic: MedDRA-flokkun eftir líffærum Viðeigandi heiti
English: 100 hard capsules
Icelandic: 100 hörð hylki
English: Your doctor may decide to increase your dose depending on how your body responds to treatment.
Icelandic: Læknirinn gæti ákveðið að auka skammtinn eftir því hvernig líkaminn bregst við meðferðinni.
English: The only infant enrolled presented with raised liver function tests within six weeks of treatment start.
Icelandic: Hjá eina ungbarninu sem tók þátt í rannsókninni komu í ljós hækkuð lifrarpróf innan sex vikna frá byrjun meðferðar.
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Icelandic: Flogaveiki hvarf hjá 100% (3/3 sjúklingum) og fjöltaugakvilli varð stöðugri eða minnkaði hjá 100% (11/11).
English: The doctor should provide information on the dose to be received according to the weight of the child.
Icelandic: Læknirinn skal veita upplýsingar um skammtastærð sem er ákveðin með hliðsjón af þyngd barnsins.
English: Do not stop taking Chenodeoxycholic acid Leadiant without first speaking with your doctor.
Icelandic: Ekki skal hætta notkun Chenodeoxycholic acid Leadiant án þess að tala fyrst við lækni.
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Icelandic: +49 (0) 89 55 066 75 25 Netfang: info@leadiantbiosciences.com
English: Constipation not known
Icelandic: Hægðatregða ekki þekkt
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Icelandic: Niðurgangur hvarf hjá 100% (23/23 sjúklingum) þeirra sjúklinga sem höfðu þau einkenni við upphafsgildi.