FrancophonIA/ELRC3.0 huggingface dataset:
English: Any remaining suspension must be discarded by your doctor or nurse according to local regulations.
Icelandic: Læknirinn eða hjúkrunarfræðingurinn skulu farga afgangsdreifu í samræmi við gildandi reglur.
English: Macimorelin induced GH release was lower in patients with higher BMI.
Icelandic: Losun vaxtarhormóns sem framkölluð var af masimorelíni var minni hjá sjúklingum með hærri líkamsþyngdarstuðul (BMI).
English: Tell your doctor if you are taking medicines that may impact the accuracy of the diagnostic test. Avoid concomitant use with medicines:
Icelandic: Láttu lækninn vita ef þú tekur lyf sem geta haft áhrif á nákvæmni greiningarprófsins.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
Icelandic: T-bylgja og lenging á QT-bili (sjá einnig kafla 4.4).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before this medicine is given to you.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum eða hjúkrunarfræðingnum áður en lyfið er notað.
English: • infections (antibiotics such as rifabutin, rifampicin)
Icelandic: • sýkingar (sýklalyf eins og rífabútín, rífampisín)
English: A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Icelandic: Ekki er hægt að útiloka möguleika á auknu aðgengi eftir inntöku og aukinni plasmaþéttni masimorelíns við notkun öflugra CYP3A4/P-gp-hemla.
English: There are no data for the use of macimorelin in pregnant women.
Icelandic: Engar upplýsingar liggja fyrir um notkun masimorelíns á meðgöngu.
English: Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin.
Icelandic: Ráðleggja skal sjúklingum sem eru á uppbótarmeðferð með vaxtarhormóni (GH, sómatótrópíni) eða lyfjum sem hafa bein áhrif á seytingu sómatótrópíns úr heiladingli (t.d. sómatóstatín hliðstæðum, klónidíni, levópóda og dópamínörvum) að hætta slíkri meðferð a.m.k. 1 mánuði áður en þeir fá tilraunaskammt af masimorelíni.
English: The suspension must be used within 30 minutes after preparation.
Icelandic: Dreifuna þarf að nota innan 30 mínútna frá blöndun.
English: Step 6
Icelandic: Skref 6
English: Step 6 Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Icelandic: Skref 6 Takið blóðsýni úr bláæð til mælinga á vaxtarhormóni 45, 60 og 90 mínútum eftir gjöf.
English: The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
Icelandic: Ráðlagður stakur skammtur af blönduðu dreifunni er 500 míkrógrömm af masimorelíni á hvert kg líkamsþyngdar.
English: Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended.
Icelandic: Mælt er með nægilega löngu útskolunartímabili (fimm helmingunartímum brotthvarfs) lyfja fyrir gjöf masimorelíns.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Icelandic: Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverjum skammtapoka, þ.e.a.s. er sem næst natríumlaust.
English: Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL.
Icelandic: Hámarkslosun vaxtarhormóns hefur komið fram við plasmaþéttni masimorelíns sem nam ≥ 7 ng/ml.
English: Macimorelin Aeterna Zentaris is not recommended during pregnancy.
Icelandic: Macimorelin Aeterna Zentaris er ekki ætlað til notkunar á meðgöngu.
English: In dose finding studies in healthy subjects, maximum stimulation of GH secretion was achieved following single dose administration of 0.5 mg/kg macimorelin.
Icelandic: Í skammtarannsókn hjá heilbrigðum einstaklingum náðist hámarksörvun á seytingu vaxtarhormóns eftir stakan 0,5 mg/kg skammt af masimorelíni.
English: • The active substance is macimorelin.
Icelandic: Virka innihaldsefnið er masimorelín.
English: Step 3
Icelandic: Skref 3
English: The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.
Icelandic: Losun vaxtarhormónsins er metin með þremur blóðprufum sem teknar eru 45, 60 og 90 mínútum eftir gjöf lyfsins.
English: • Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
Icelandic: Lyfjum sem geta aukið blóðþéttni vaxtarhormóns tímabundið (eins og klónidín, levódópa og insúlín).
English: Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin.
Icelandic: 45 til 60 mínútum eftir gjöf masimorelíns.
English: Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
Icelandic: Laktósaeinhýdrat Vatnsfrí kísilkvoða Krospóvídón gerð A Sakkarínnatríum tvíhýdrat Natríumstearýl fúmarat
English: The suspension must be taken within 30 minutes after preparation.
Icelandic: Dreifuna þarf að taka innan 30 mínútna frá blöndun.
English: Reconstituted suspension:
Icelandic: Blönduð dreifa:
English: How Macimorelin Aeterna Zentaris is stored 6.
Icelandic: 5. Hvernig geyma á Macimorelin Aeterna Zentaris 6.
English: The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Icelandic: Ekki hefur verið sýnt fram á lokapunktinn[SH2] fyrir masimorelín á umskiptatímanum frá lokaskeiði kynþroska og þar til fullorðinsþroska er náð.
English: Long-term use
Icelandic: Langtímanotkun
English: The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Icelandic: Magn dreifu í ml sem þarf fyrir ráðlagðan skammt af masimorelíni sem er 0,5 mg/kg, jafngildir líkamsþyngd sjúklingsins í kg.
English: Residual suspension must be discarded according to local regulations.
Icelandic: Farga skal afgangsdreifu í samræmi við gildandi reglur.
English: The test was considered positive (i.e., growth hormone deficiency (GHD) diagnosed) if the maximum serum GH level observed after stimulation was less than the pre-specified cut-off point of 2.8 ng/mL for the MAC test or 5.1 ng/mL for the ITT.
Icelandic: Prófið var talið jákvætt (þ.e. vaxtarhormónaskortur greindur) ef hámarksgildi vaxtarhormóns í sermi sem kom fram eftir örvun var lægra en fyrirfram tilgreind viðmiðunarmörk[SH3] (cut-off point) sem námu
English: Growth hormone medicinal products should be discontinued at least 1 month before administering macimorelin.
Icelandic: Hætta skal notkun vaxtarhormónalyfja a.m.k. 1 mánuði fyrir gjöf masimorelíns.
English: The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Icelandic: Til dæmis þarf 70 kg sjúklingur 70 ml af masimorelín dreifunni.
English: Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin.
Icelandic: Masimorelín er peptíðeftirlíking til inntöku með seytingarörvandi virkni á vaxtarhormón (GH) sem er sambærileg við grelín.
English: Step 2
Icelandic: Skref 2
English: Step 4
Icelandic: Skref 4
English: • that could have a direct influence on growth hormone secretion by the pituitary gland: such as somatostatin, insulin, glucocorticoids, acetylsalicylic acid,
Icelandic: sem gætu haft bein áhrif á seytingu vaxtarhormóns frá heiladingli: eins og sómatóstatín, insúlín,
English: Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
Icelandic: Ráðleggja skal sjúklingum sem eru á uppbótarmeðferð með vaxtarhormóni (GH, sómatótrópíni) eða lyfjum sem hafa bein áhrif á seytingu sómatótrópíns úr heiladingli (t.d. sómatóstatín hliðstæðum, klónidíni, levópóda og dópamínörvum) að hætta slíkri meðferð a.m.k. 1 mánuði áður en þeir fá masimorelín.
English: Excipient(s) with known effect
Icelandic: VIRK(T) EFNI
English: Assessment of fasted condition and lack of prior strenuous physical exercise
Icelandic: Mat á föstuástandi og fyrri líkamsþjálfun
English: QTc prolongation
Icelandic: Lenging á QTc-bili
English: The following medicinal products may impact the accuracy of the diagnostic test. Concomitant use is to be avoided with (see also section 4.2 and section 4.4):
Icelandic: Forðast skal samhliða notkun með (sjá einnig kafla 4.2 og kafla 4.4):
English: The suspension must be prepared and administered by a healthcare professional.
Icelandic: Heilbrigðisstarfsmaður þarf að blanda og gefa dreifuna.
English: Growth hormone secretion normally decreases with age.
Icelandic: Venjulega dregur úr seytingu vaxtarhormóns með aldrinum.
English: This study showed a mean baseline- and placebo-adjusted change (upper single-sided 95% confidence interval) in QTcF of 9.6 ms (11.4 ms) at 4 h post-dose (see also section 4.4), which occurred after the mean maximum macimorelin plasma concentration (0.5 h).
Icelandic: á QTcF-bili, aðlöguð fyrir upphafs- og lyfleysugildi, (efri einhliða 95% öryggisbil) sem nam að meðaltali 9,6 ms (11,4 ms) 4 klst.
English: Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Icelandic: Engar upplýsingar liggja fyrir um öryggi og áhrif masimorelíns við langtíma notkun.
English: Positive agreement is the proportion of subjects with a positive ITT (i.e., those who have GHD per the ITT) who also have a positive macimorelin test. With a high level of positive agreement, the MAC test will not wrongly diagnose an individual with GHD per the ITT as not having GHD.
Icelandic: Samræmdar jákvæðar niðurstöður er hlutfall einstaklinga með jákvætt ITT (þ.e. sem eru með vaxtarhormónaskort á ITT) sem einnig eru með jákvætt masimorelín próf.
English: You must not be given Macimorelin Aeterna Zentaris • if you are allergic to macimorelin or any of the other ingredients of this medicine (listed in section 6).
Icelandic: ef um er að ræða ofnæmi fyrir masimorelíni eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: Macimorelin is moderately bound to plasma proteins.
Icelandic: Masimorelín er miðlungsmikið bundið plasmapróteinum.
English: What Macimorelin Aeterna Zentaris looks like and contents of the pack
Icelandic: Lýsing á útliti Macimorelin Aeterna Zentaris og pakkningastærðir
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Icelandic: VIÐAUKI II A. FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN C. AÐRAR FORSENDUR OG SKILYRÐI MARKAÐSLEYFIS D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: Dysgeusia (bitter/metallic taste)
Icelandic: Bragðtruflun (beiskt/málmbragð)
English: ECG QT prolonged
Icelandic: Verkunarmátinn fyrir lengingu
English: Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Icelandic: Takið blóðsýni úr bláæð til mælinga á vaxtarhormóni 45, 60 og 90 mínútum eftir gjöf.
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension macimorelin
Icelandic: Macimorelin Aeterna Zentaris 60 mg mixtúrukyrni, dreifa masimorelín
English: What Macimorelin Aeterna Zentaris contains
Icelandic: Macimorelin Aeterna Zentaris inniheldur
English: Driving and using machines Dizziness can occur with Macimorelin Aeterna Zentaris.
Icelandic: Sundl getur komið fram við notkun Macimorelin Aeterna Zentaris.
English: Nervous system disorders
Icelandic: Óeðlileg T-bylgja á hjartarafriti
English: • palpitations
Icelandic: • kuldatilfinning
English: Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Icelandic: Macimorelin Aeterna Zentaris 60 mg mixtúrukyrni, dreifa í skammtapoka masimorelín
English: • that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
Icelandic: sem gætu dregið úr svörun vaxtarhormóns við masimorelíni eins og: atrópín, própýlþíóúrasíl,
English: Macimorelin was absorbed rapidly and the maximum plasma macimorelin concentrations (Cmax) were observed approximately 30 minutes to 1 hour and 10 minutes after oral administration of 0.5 mg/kg macimorelin after fasting for at least 8 hours.
Icelandic: 30 mínútum til 1 klst. og 10 mínútum eftir inntöku á 0,5 mg/kg af masimorelíni eftir föstu sem stóð yfir í a.m.k. 8 klst.
English: All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes.
Icelandic: QT rannsókninni, sem bendir til þess að skammtaháðar breytingar séu ekki til staðar.
English: In patients with known congenital or acquired long QT syndrome and in patients with a history of torsades de pointes, the use of macimorelin may only be considered in a cardiovascular clinical unit.
Icelandic: Masimorelín má eingöngu nota á klínískum hjartadeildum hjá sjúklingum með þekkt meðfætt eða áunnið QT-lengingar heilkenni og hjá sjúklingum með sögu um torsades de pointes.
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1).
Icelandic: 11 ms með óþekktum verkunarmáta (sjá einnig kafla 5.1).
English: The suspension must be administered within 30 minutes after preparation.
Icelandic: Dreifuna þarf að gefa innan 30 mínútna frá blöndun.
English: Fluid intake of no more than 100 mL of non-carbonated water is allowed each within 1 hour pre-dose, as well as within 1 hour post-dose (see section 4.4).
Icelandic: Vökvainntaka sem er að hámarki 100 ml af ókolsýrðu vatni er leyfileg innan 1 klst.
English: What you need to know before Macimorelin Aeterna Zentaris is given
Icelandic: Áður en byrjað er að nota Macimorelin Aeterna Zentaris
English: STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Icelandic: Inniheldur 60 mg af masimorelíni (sem asetat) Eftir blöndun:
English: How Macimorelin Aeterna Zentaris is given
Icelandic: Hvernig nota á Macimorelin Aeterna Zentaris
English: White to off-white granules.
Icelandic: Hvítt eða beinhvítt kyrni.
English: Fertility
Icelandic: vaxtarhormónalyf
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Icelandic: HEITI LYFS Macimorelin Aeterna Zentaris 60 mg mixtúrukyrni, dreifa í skammtapoka
English: ECG T wave abnormal
Icelandic: Örvun vaxtarhormóns
English: • lower than normal heart rate (sinus bradycardia)
Icelandic: hægari hjartsláttur en venjulega (skútahægsláttur)
English: How Macimorelin Aeterna Zentaris is stored
Icelandic: Macimorelin Aeterna Zentaris inniheldur laktósa
English: A decision must be made whether to discontinue breast-feeding or to abstain from macimorelin, taking into account the benefit of breast-feeding for the child and the benefit of the test 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/stöðva tímabundið meðferð með masimorelíni.
English: Unopened sachet
Icelandic: Blönduð dreifa
English: • medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
Icelandic: lyf til að leiðrétta hjartsláttartruflanir (lyf gegn hjartsláttartruflunum eins og amíódarón,
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: Abdominal pain
Icelandic: Órofinn skammtapoki
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
Icelandic: T-bylgja og lenging á QT-bili.
English: PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Icelandic: MEÐ BLINDRALETRI Fallist hefur verið á rök fyrir undanþágu frá kröfu um blindraletur.
English: Sinus bradycardia
Icelandic: B. FYLGISEÐILL
English: Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
Icelandic: Xofigo 1100 kBq/ml
English: 6.0 mL
Icelandic: Til notkunar í bláæð Hettuglas (gler) 6,0 ml
English: Name Strength
Icelandic: Styrkleiki
English: Vial (glass)
Icelandic: Heiti
English: Strength Pharmaceutical Form Route of Administration
Icelandic: Evrópskt markaðsleyfisnúm er
English: It is not known how commonly they occur.
Icelandic: Ekki er vitað hversu algengar þær eru.
English: Your doctor can advise you what would be best.
Icelandic: Læknirinn getur ráðlagt þér hvað best er að gera.
English: Most patients (91%) were <65 years of age.
Icelandic: Flestir sjúklingar (91%) voru <65 ára.
English: 9/L, then treatment must be stopped immediately.
Icelandic: 9/l verður tafarlaust að hætta meðferð.
English: How many tablets to take during the day Number of tablets per day
Icelandic: Hversu margar töflur á að taka yfir daginn
English: Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Icelandic: Börn og unglingar undir 18 ára aldri mega ekki taka lyfið þar sem það hefur ekki verið rannsakað hjá þessum aldurshópi.
English: Two-sided 99.24% CI
Icelandic: Tvíhliða 99,24% CI
English: One-sided 97.5% repeated CI (lower limit)
Icelandic: Einhliða 97,5% endurtekin CI (neðri mörk)
English: You may not need the maximum dose of 720 mg per day.
Icelandic: Ekki er víst að þú þurfir hámarksskammtinn 720 mg á dag.
English: Take your tablets during or immediately after a meal.
Icelandic: Taktu töflurnar með eða strax eftir máltíð.
English: White blood cells help your body to fight infections.
Icelandic: Hvít blóðkorn hjálpa líkamanum að verjast sýkingum.
English: Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets).
Icelandic: Læknirinn mun hefja meðferðina með lágum skammti (með því að nota 30 mg Skilarence-töflur).
English: Date of first authorisation: 23 june 2017
Icelandic: 23. júní 2017
English: Skilarence may cause problems with your blood, liver or kidneys.
Icelandic: Skilarence getur valdið vandamálum með blóðið, lifrina eða nýrun.
English: A risk to newborns or infants cannot be excluded.
Icelandic: Ekki er hægt að útiloka hættu fyrir nýbura eða börn sem eru á brjósti .
English: Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people.
Icelandic: Roði í andliti eða líkama er mjög algeng aukaverkun sem getur komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum.
English: 9/L but is ≥0.7 x10
Icelandic: 9/l en er ≥0,7x10
English: Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby.
Icelandic: Ekki taka Skilarence ef þú ert þunguð eða ert að reyna að verða þunguð, þar sem Skilarence getur skaðað barnið.
English: Most adverse reactions were considered mild and did not lead to discontinuation of study treatment.
Icelandic: Flestar aukaverkanirnar voru vægar og leiddu ekki til þess að rannsóknarmeðferðinni væri hætt.
English: Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years.
Icelandic: Af 699 sjúklingum voru flestir hvítir (99%) og karlar (65%) og meðalaldurinn var 44 ár.
English: Skilarence may reduce the number of your white blood cells.
Icelandic: Skilarence getur dregið úr fjölda hvítra blóðkorna.
English: Brain infection called PML
Icelandic: Sýking í heila sem kallast PML
English: Talk to your doctor if you think you may have an infection.
Icelandic: Ræddu við lækninn ef þú heldur að þú gætir verið með sýkingu.
English: You may feel dizzy or tired after taking Skilarence.
Icelandic: Þú getur fundið fyrir svima eða þreytu eftir töku Skilarence.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnupakkningunni á eftir „EXP“.
English: In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy.
Icelandic: Sérstaklega ef þú ert að taka getnaðarvarnarlyf (pilluna), áhrif geta minnkað og þú gætir þurft að nota aðrar hindrunaraðferðir til að koma í veg fyrir þungun.
English: E-08740 Sant Andreu de la Barca, Barcelona Spain
Icelandic: E-08740 Sant Andreu de la Barca, Barcelona Spánn
English: The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
Icelandic: Einu aukaverkanirnar sem leiddu til þess að hætta þurfti meðferð hjá >5% sjúklinga voru viðbrögð frá meltingarvegi.
English: The tablets are packed in PVC/PVDC-aluminium blisters.
Icelandic: Töflunum er pakkað í PVC/PVDC-álþynnur.
English: 9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Icelandic: 9/l hjá 1/29 (3,5%) sjúklingi eftir 6 mánuði og 0/28 (0%) 12 mánuðum eftir að meðferð var hætt.
English: From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening.
Icelandic: Frá fjórðu vikunni er meðferðinni breytt þannig að eingöngu er tekin 1 tafla af Skilarence 120 mg að kvöldi.
English: Action is needed in the following circumstances:
Icelandic: Grípa þarf til ráðstafana við eftirfarandi aðstæður:
English: Summary of clinical efficacy after 16 weeks treatment in Study 1102 Assessment
Icelandic: Samantekt á klínískri verkun eftir 16 vikna meðferð í rannsókn 1102
English: A modified or weakened immune system as well as genetic or environmental factors can also constitute risk factors.
Icelandic: Breytt eða veiklað ónæmiskerfi sem og erfða- eða umhverfisþættir geta einnig talist áhættuþættir.
English: If you forget to take Skilarence
Icelandic: Ef gleymist að taka Skilarence
English: No specific antidote is known.
Icelandic: Ekkert sérstakt mótlyf er þekkt.
English: Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach.
Icelandic: Ekki mylja, brjóta, leysa upp eða tyggja töflurnar, því þær hafa sérstaka húð sem hjálpar til við að hindra ertingu í maga.
English: The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Skilarence hjá börnum yngri en 18 ára.
English: Check with your doctor or pharmacist if you are not sure.
Icelandic: Leitaðu til læknisins eða lyfjafræðings ef þú ert ekki viss.
English: 9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10
Icelandic: 9/l verður að endurtaka blóðprufuna og ef staðfest hefur verið að gildin séu undir 0,7x10
English: Allergic or hypersensitivity reactions are rare but may be very serious.
Icelandic: Ofnæmi eða ofnæmisviðbrögð eru mjög sjaldgæf en geta verið mjög alvarleg.
English: PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
Icelandic: PML er tækifærissýking af völdum John-Cunningham veiru (JCV) sem getur verið banvæn eða valdið alvarlegri fötlun.
English: Skilarence with alcohol
Icelandic: Notkun Skilarence með áfengi