FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/570/029 90 film-coated tablets
Icelandic: EU/1/09/570/029 90 filmuhúðaðar töflur
English: EU/1/09/570/026 28 film-coated tablets
Icelandic: EU/1/09/570/026 28 filmuhúðaðar töflur
English: If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Icelandic: Ef skammt er um liðið frá því lyfið var tekið inn má íhuga að framkalla uppköst eða beita magaskolun.
English: EU/1/09/570/040 56 film-coated tablets
Icelandic: EU/1/09/570/040 56 filmuhúðaðar töflur
English: • spinning sensation
Icelandic: • breytt bragðskyn
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Imprida HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: EU/1/09/570/053 90 film-coated tablets
Icelandic: EU/1/09/570/053 90 filmuhúðaðar töflur
English: EU/1/09/570/005 90 film-coated tablets
Icelandic: EU/1/09/570/005 90 filmuhúðaðar töflur
English: • dizziness
Icelandic: • þróttleysi
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Imprida HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: Based on the pharmacological mechanism of action of hydrochlorothiazide, its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Icelandic: Á grundvelli lyfjafræðilegs verkunarháttar hýdróklórtíazíðs getur notkun þess á öðrum og síðasta þriðjungi meðgöngu haft áhrif á flæði milli fósturs og fylgju og getur m.a. valdið gulu, truflunum á saltajafnvægi og blóðflagnafæð hjá fóstri eða nýbura.
English: EU/1/09/570/003 30 film-coated tablets
Icelandic: EU/1/09/570/003 30 filmuhúðaðar töflur
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Imprida HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Icelandic: Imprida HCT, 32,0/19,7 mmHg hjá þeim sem fengu valsartan/hýdróklórtíazíð, 33,5/21,5 mmHg hjá þeim sem fengu amlodipin/valsartan og 31,5/19,5 mmHg hjá þeim sem fengu amlodipin/hýdróklórtíazíð.
English: Change of bowel habit
Icelandic: Breytingar á söltum í sermi
English: EU/1/09/570/037 14 film-coated tablets
Icelandic: EU/1/09/570/037 14 filmuhúðaðar töflur
English: EU/1/09/570/051 30 film-coated tablets
Icelandic: EU/1/09/570/051 30 filmuhúðaðar töflur
English: Yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VEL” on the other side.
Icelandic: Gular, sporöskjulaga töflur með sniðbrún og kúptar á báðum hliðum, auðkenndar með „NVR“ á annarri hliðinni og „VEL“ á hinni hliðinni.
English: • trembling
Icelandic: • bakverkur
English: • high level of uric acid in the blood
Icelandic: • mikið magn sykurs í blóði
English: In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
Icelandic: Hjá sjúklingum með sykursýki getur þurft að breyta skömmtum insúlíns eða sykursýkislyfja til inntöku.
English: This could result in sub-therapeutic effects of thiazide diuretics.
Icelandic: Þetta getur leitt til þess að meðferðaráhrif tíazíð þvagræsilyfja náist ekki.
English: EU/1/09/570/039 30 film-coated tablets
Icelandic: EU/1/09/570/039 30 filmuhúðaðar töflur
English: EU/1/09/570/014 28 film-coated tablets
Icelandic: EU/1/09/570/014 28 filmuhúðaðar töflur
English: Imprida HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Icelandic: HCT skal aðeins nota eftir að natríumskortur og/eða minnkað blóðrúmmál hefur verið leiðrétt.
English: Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Icelandic: barksterum, hægðalyfjum, amphotericini eða penicillini G
English: All of these substances help to control high blood pressure.
Icelandic: Öll þrjú efnin lækka blóðþrýsting.
English: • weakness
Icelandic: • mislitun
English: EU/1/09/570/028 56 film-coated tablets
Icelandic: EU/1/09/570/028 56 filmuhúðaðar töflur
English: • tiredness
Icelandic: • skjálfti
English: EU/1/09/570/002 28 film-coated tablets
Icelandic: EU/1/09/570/002 28 filmuhúðaðar töflur
English: EU/1/09/570/017 90 film-coated tablets
Icelandic: EU/1/09/570/017 90 filmuhúðaðar töflur
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Imprida HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: EU/1/09/570/015 30 film-coated tablets
Icelandic: EU/1/09/570/015 30 filmuhúðaðar töflur
English: • high level of sugar in the blood
Icelandic: • mikið magn af þvagsýru í blóði
English: EU/1/09/570/013 14 film-coated tablets
Icelandic: EU/1/09/570/013 14 filmuhúðaðar töflur
English: EU/1/09/570/044 56 x 1 film-coated tablet (unit dose) EU/1/09/570/045 98 x 1 film-coated tablet (unit dose) EU/1/09/570/046 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/570/044 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/045 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/046 280 x 1 filmuhúðuð tafla (stakskammtar)
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Imprida HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Icelandic: Hver tafla inniheldur amlodipin 10 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 25 mg.
English: • increase of lipids in the blood
Icelandic: • aukið magn af fitum í blóði
English: EU/1/09/570/032 56 x 1 film-coated tablet (unit dose) EU/1/09/570/033 98 x 1 film-coated tablet (unit dose) EU/1/09/570/034 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/570/032 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/033 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/034 280 x 1 filmuhúðuð tafla (stakskammtar)
English: Renal impairment
Icelandic: Aukning lípíða
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).
Icelandic: Önnur innihaldsefni eru örkristölluð sellulósa; crospovidon; vatnsfrí kísilkvoða; magnesíumsterat; hýprómellósa; macrogol 4000; talkúm; títantvíoxíð (E171).
English: • low level of potassium in the blood
Icelandic: • lítið af kalíum í blóði
English: EU/1/09/570/008 56 x 1 film-coated tablet (unit dose) EU/1/09/570/009 98 x 1 film-coated tablet (unit dose) EU/1/09/570/010 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/570/008 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/009 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/010 280 x 1 filmuhúðuð tafla (stakskammtar)
English: Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Icelandic: Samhliða notkun með þvagræsilyfjum af flokki tíazíða, þ.m.t. hýdróklórtíazíði, getur aukið tíðni ofnæmis fyrir allopurinoli.
English: EU/1/09/570/050 28 film-coated tablets
Icelandic: EU/1/09/570/050 28 filmuhúðaðar töflur
English: Reproductive studies in rats and mice have shown delayed date of delivery, prolonged duration of labour and decreased pup survival at dosages approximately 50 times greater than the maximum recommended dosage for humans based on mg/kg.
Icelandic: Í rannsóknum á æxlun hjá rottum og músum hefur orðið vart við seinkun gots, lengingu hríða og minni lifun unga við skammta u.þ.b.
English: Other anti-hypertensive drugs
Icelandic: Frumueyðandi lyf
English: EU/1/09/570/056 56 x 1 film-coated tablet (unit dose) EU/1/09/570/057 98 x 1 film-coated tablet (unit dose) EU/1/09/570/058 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/570/056 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/057 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/058 280 x 1 filmuhúðuð tafla (stakskammtar)
English: Sodium- and/or volume-depleted patients
Icelandic: Lækkun slagbils-/þanbilsþrýstings hjá þeim sem fengu
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver tafla inniheldur amlodipin 10 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 12,5 mg.
English: Leukopenia
Icelandic: Brisbólga
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VFL” on the other side.
Icelandic: Gulbrúnar, sporöskjulaga töflur með sniðbrún og kúptar á báðum hliðum, auðkenndar með „NVR“ á annarri hliðinni og „VFL“ á hinni hliðinni.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Icelandic: Hver tafla inniheldur amlodipin 5 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 25 mg.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).
Icelandic: Önnur innihaldsefni eru örkristölluð sellulósa; crospovidon; vatnsfrí kísilkvoða; magnesíumsterat; hýprómellósa; macrogol 4000; talkúm; gult járnoxíð (E172).
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Imprida HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Diarrhoea
Icelandic: Lifrarbólga
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Icelandic: Imprida HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur eru fölgular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VDL“ á hinni hliðinni.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Icelandic: Önnur innihaldsefni eru örkristölluð sellulósa; crospovidon; vatnsfrí kísilkvoða; magnesíumsterat; hýprómellósa; macrogol 4000; talkúm; títantvíoxíð (E171); gult járnoxíð (E172).
English: • nausea
Icelandic: • niðurgangur
English: Gynaecomastia
Icelandic: INNIHALDSLÝSING
English: NAME OF THE MEDICINAL PRODUCT
Icelandic: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
English: EU/1/09/570/020 56 x 1 film-coated tablet (unit dose) EU/1/09/570/021 98 x 1 film-coated tablet (unit dose) EU/1/09/570/022 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/570/020 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/021 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/570/022 280 x 1 filmuhúðuð tafla (stakskammtar)
English: EU/1/09/570/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Icelandic: EU/1/09/570/036 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/570/035 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Icelandic: Hver tafla inniheldur amlodipin 5 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 12,5 mg.
English: EU/1/09/570/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Icelandic: EU/1/09/570/048 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/570/047 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: Thus, only information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Icelandic: Engar formlegar rannsóknir á milliverkunum við önnur lyf hafa verið gerðar með Imprida HCT Þess vegna eru í þessum kafla einungis tilgreindar milliverkanir við önnur lyf sem þekktar eru fyrir hvert virku innihaldsefnanna fyrir sig.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Imprida HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: EU/1/09/570/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Icelandic: EU/1/09/570/060 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/570/059 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Icelandic: Imprida HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur eru gulbrúnar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VHL“ á hinni hliðinni.
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side.
Icelandic: Gulbrúnar, sporöskjulaga töflur með sniðbrún og kúptar á báðum hliðum, auðkenndar með „NVR“ á annarri hliðinni og „VHL“ á hinni hliðinni.
English: EU/1/09/570/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Icelandic: EU/1/09/570/012 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/570/011 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: Thiazide diuretics can precipitate new onset hyponatraemia and hypochloroaemic alkalosis or exacerbate pre-existing hyponatraemia.
Icelandic: Tíazíð þvagræsilyf geta leitt til blóðkalíumlækkunar eða aukið blóðkalíumlækkun sem þegar er til staðar.
English: All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium.
Icelandic: Hafa skal reglulegt eftirlit með jafnvægi blóðsalta, sérstaklega kalíums, natríums og magnesíums, hjá öllum sjúklingum sem fá tíazíð þvagræsilyf.
English: • stiffness
Icelandic: • brjóstverkur
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur amlodipin 10 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 25 mg.
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur amlodipin 10 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 12,5 mg.
English: EU/1/09/570/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Icelandic: EU/1/09/570/024 280 filmuhúðaðar töflur (fjölpakkning, 20 öskjur með 14 töflum) EU/1/09/570/023 280 filmuhúðaðar töflur (fjölpakkning, 4 öskjur með 70 töflum)
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur amlodipin 5 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 25 mg.
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur amlodipin 5 mg (sem amlodipinbesylat), valsartan 160 mg og hýdróklórtíazíð 12,5 mg.
English: Similar outcomes have been reported with valsartan.
Icelandic: Greint hefur verið frá svipuðum niðurstöðum vegna valsartans.
English: Abasia, gait disturbance
Icelandic: Truflun á þvaglátum
English: This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Imprida HCT is not recommended.
Icelandic: Það er sjúkdómur sem felur í sér að nýrnahetturnar framleiða of mikið af hormóninu aldósteróni.
English: • severely decreased urine output
Icelandic: • mikil minnkun á þvagmagni
English: Serum electrolyte changes
Icelandic: • dantroleni (innrennsli við verulegum breytingum á líkamshita)
English: • swelling
Icelandic: • nefrennsli
English: Ion exchange resins
Icelandic: Röskun á samhæfingu
English: Impotence
Icelandic: Þróttleysi
English: • low level of sodium in the blood
Icelandic: • lítið af natríum í blóði
English: • irregular heart beat
Icelandic: Brjóstverkur sem ekki tengist hjarta
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Icelandic: Upplýsingar á íslensku eru á http://www.serlyfjaskra.is
English: Pharmacovigilance system
Icelandic: Lyfjagátarkerfi
English: Tablet core
Icelandic: Vöðvakippir
English: Imprida HCT individual component
Icelandic: Imprida HCT
English: EXPIRY DATE
Icelandic: • tíð þvaglát
English: Dyspepsia
Icelandic: Skjálfti
English: • headache
Icelandic: • syfja
English: Sucralose (E955)
Icelandic: Súkralósi (E955)
English: The following side effects could be very serious:
Icelandic: Eftirfarandi aukaverkanir gætu verið mjög alvarlegar:
English: This will help protect the environment.
Icelandic: Markmiðið er að vernda umhverfið.
English: Each ml of solution contains:
Icelandic: Hver ml af lausn inniheldur:
English: If you have any solution left in the bottle more than 8 weeks after it was first opened, you should not use it.
Icelandic: Ef einhver lausn er eftir í glasinu meira en 8 vikum eftir að glasið var fyrst opnað ætti ekki að nota hana.
English: Contact your doctor or go to a hospital straight away.
Icelandic: Hafðu samband við lækninn eða farðu tafarlaust á sjúkrahús.
English: If your liver is not working properly, your treatment may need to be stopped.
Icelandic: Ef lifrin þín starfar ekki rétt þarf mögulega að stöðva meðferðina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/19/1389/001
English: The increase was reversible in healthy adults.
Icelandic: Aukningin gekk til baka hjá heilbrigðum fullorðnum einstaklingum.
English: Contact your doctor or go to a hospital straight away (See section 4).
Icelandic: Hafðu tafarlaust samband við lækninn eða farðu á sjúkrahús (sjá kafla 4).
English: Tell the doctor if you have any of the following:
Icelandic: Láttu lækninn vita ef eitthvað af eftirfarandi á við hjá þér:
English: In addition, monitoring of plasma concentrations should be considered.
Icelandic: Að auki skal íhuga eftirlit með plasmaþéttni.
English: No effect
Icelandic: Engin áhrif
English: Use within 8 weeks after first opening the bottle.
Icelandic: Notið innan 8 vikna eftir að glasið hefur verið opnað.
English: If you have these thoughts at any time, contact your doctor
Icelandic: Ef þú finnur fyrir slíkum hugsunum skaltu hafa samband við lækninn
English: Continue to use the medicine as normal.
Icelandic: Haltu áfram að nota lyfið eins og áður.
English: The Netherlands E-mail: info@gwpharm.com
Icelandic: Netfang: info@gwpharm.com
English: If the solution in the bottle has turned cloudy, this doesn't change how well it works.
Icelandic: Ef lausnin í glasinu verður skýjuð breytir það ekki virkni hennar.
English: Suicidal behaviour and ideation
Icelandic: Sjálfsvígshegðun og sjálfsvígshugsanir
English: One 100 ml bottle
Icelandic: Eitt 100 ml glas
English: Elderly (65 years of age and above) The safety and efficacy of cannabidiol in patients ≥ 65 years of age have not been established.
Icelandic: Aldraðir (65 ára og eldri) Ekki hefur verið sýnt fram á öryggi og verkun kannabídíóls hjá sjúklingum ≥ 65 ára.
English: Your doctor and pharmacist will tell you how much (number of ml) Epidyolex to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml).
Icelandic: Læknirinn og lyfjafræðingur mun segja þér hversu mikið af Epidyolex (hve marga millilítra) þú átt að taka á hverjum degi, hversu oft þú átt að taka lyfið yfir daginn og hvora sprautuna þú átt að nota til að mæla réttan skammt (1 ml eða 5 ml).
English: (See also section 3, How to take Epidyolex).
Icelandic: (Sjá einnig kafla 3, Hvernig nota á Epidyolex).
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Icelandic: a meðalaukning um 47% fyrir AUC og 73% fyrir Cmax b byggt á gildum Cmax og AUC
English: You may start on a low dose that your doctor gradually increases over time.
Icelandic: Þú gætir byrjað á lágum skömmtum sem læknirinn eykur smám saman með tímanum.
English: Increases in creatinine
Icelandic: Hækkun á kreatíníni
English: - If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
Icelandic: - Ef flogin koma oftar fyrir eða ef þú færð alvarlegt flog á meðan þú tekur Epidiolex.
English: If you miss many doses, please talk to your doctor about the correct dose to take.
Icelandic: Ef margir skammtar gleymast skal ræða við lækninn um hvaða skammt rétt er að taka.
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Icelandic: Ekki minnka skammtinn þinn eða hætta að taka lyfið nema læknirinn segi þér að gera það.
English: - you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself.
Icelandic: - þú tekur eftir óvenjulegum skapbreytingum eða færð sjálfsskaða- eða sjálfsvígshugsanir.
English: Take the next dose at your regular time.
Icelandic: Taka skal næsta skammt á venjulegum tíma.
English: Each ml of Epidyolex contains 79 mg of ethanol.
Icelandic: Hver ml af Epidyolex inniheldur 79 mg af etanóli.
English: The elevations typically occur in the first two months of treatment initiation; however, there were cases observed up to 18 months after initiation of treatment, particularly in patients taking concomitant valproate.
Icelandic: Hækkunin kemur venjulega fram á fyrstu tveimur mánuðum meðferðar; samt sem áður komu fram tilvik allt að 18 mánuðum eftir að meðferð var hafin, einkum hjá sjúklingum sem tóku valpróat samhliða.
English: Effect of age, weight, sex, race
Icelandic: Áhrif aldurs, þyngdar, kyns, kynþáttar
English: The apparent volume of distribution was high in healthy volunteers at 20,963 L to 42,849 L and greater than total body water, suggesting a wide distribution of cannabidiol.
Icelandic: Hjá heilbrigðum sjálfboðaliðum var dreifingarrúmmálið mikið, eða 20.963 l til 42.849 l og meira en heildarlíkamsvökvinn, sem bendir til mikillar dreifingar kannabídíóls.
English: Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Icelandic: Sjúklingum skal ráðlagt að aka ekki né stjórna vélum fyrr en nægileg reynsla er komin á notkun þeirra á lyfinu til að meta hvort það hefur áhrif á hæfni þeirra (sjá kafla 4.8).
English: Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products (dose change or additions) that are known to impact the liver, this monitoring schedule should be restarted.
Icelandic: Við breytingar á skömmtum kannabídíóls sem eru yfir 10 mg/kg/sólarhring eða breytinga á lyfjum (breyting eða aukning á skömmtum) sem vitað er að hafa áhrif á lifur skal hefja þessa eftirlitsáætlun aftur.
English: 736 mg refined sesame oil
Icelandic: 736 mg hreinsuð sesamolía
English: The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Icelandic: Ekki hefur enn verið sýnt fram á öryggi og verkun kannabídíóls hjá börnum á aldrinum 6 mánaða til 2 ára.
English: Do not start or stop other medicines without talking to your doctor or pharmacist.
Icelandic: Ekki byrja eða hætta að taka önnur lyf án þess að ræða fyrst við lækninn eða lyfjafræðing.
English: 3821AL Amersfoort, The Netherlands
Icelandic: 3821AL Amersfoort, Holland
English: In some cases, the decreased weight was reported as an adverse event (see the table above).
Icelandic: Í sumum tilvikum var þyngdartap tilgreint sem aukaverkun (sjá töflu hér að ofan).
English: It is important that you use the correct oral syringe to measure your dose.
Icelandic: Það er mikilvægt að þú notir rétta munngjafarsprautu til að mæla skammtinn.