FrancophonIA/ELRC3.0 huggingface dataset:
English: SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, of oval shape, and flat.
Icelandic: SIFROL 0,18 mg töflur og 0,35 mg töflur eru hvítar, sporöskjulaga og flatar.
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following: - Kidney disease.
Icelandic: Láttu lækninn vita ef þú ert með, hefur haft eða færð einhvern sjúkdómskvilla, eða einkenni, sérstaklega eitthvað af eftirtöldu: nýrnasjúkdóm.
English: When prescribing SIFROL in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Icelandic: Þegar SIFROL er ávísað handa Parkinsonssjúklingum með skerta nýrnastarfsemi er lagt til að litlir skammtar séu notaðir, samsvarandi þeim sem eru tilgreindir í kafla 4.2.
English: SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Icelandic: Tengsl hafa sést á milli notkunar SIFROL og syfju og þekkt eru tilfelli þar sem sjúklingur fellur skyndilega í svefn, sérstaklega sjúklingar með Parkinsonsveiki.
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg three times a day (equivalent to 0.264 mg daily):
Icelandic: Fyrstu vikuna er venjulegur skammtur ein SIFROL 0,088 mg tafla þrisvar sinnum á sólarhring (jafngildir 0,264 mg á sólarhring).
English: If you are switching from SIFROL (immediate release) tablets Your doctor will base your dose of SIFROL prolonged-release tablets on the dose of SIFROL (immediate release) tablets you were taking.
Icelandic: Læknirinn mun miða skammt þinn af SIFROL forðatöflum við þann skammt af SIFROL töflum sem þú hefur verið að nota.
English: The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma)
Icelandic: Meðal einkenna eru: hreyfingatregða (missir hreyfigetu) stífir vöðvar hiti óstöðugur blóðþrýstingur hraðtaktur (aukinn hjartsláttur) rugl minnkuð meðvitund (t.d. dá)
English: Rare may affect up to 1 in 1,000 people
Icelandic: geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum
English: What SIFROL contains
Icelandic: SIFROL inniheldur
English: However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected.
Icelandic: Hins vegar komu ekki fram klínískt mikilvæg áhrif líkamsþyngdar á meðferðarsvörun og þolanleika SIFROL forðataflna í fasa III rannsóknum hjá sjúklingum með Parkinsonsveiki.
English: SIFROL is used to treat the symptoms of primary Parkinson's disease in adults.
Icelandic: SIFROL er notað til meðhöndlunar á einkennum frumkominnar Parkinsonsveiki hjá fullorðnum.
English: Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
Icelandic: Ekki er mælt með notkun SIFROL fyrir börn og unglinga yngri en 18 ára.
English: SIFROL 0.26 mg prolonged-release tablets SIFROL 0.52 mg prolonged-release tablets SIFROL 1.05 mg prolonged-release tablets SIFROL 1.57 mg prolonged-release tablets SIFROL 2.1 mg prolonged-release tablets SIFROL 2.62 mg prolonged-release tablets SIFROL 3.15 mg prolonged-release tablets
Icelandic: SIFROL 0,26 mg forðatöflur SIFROL 0,52 mg forðatöflur SIFROL 1,05 mg forðatöflur SIFROL 1,57 mg forðatöflur SIFROL 2,1 mg forðatöflur SIFROL 2,62 mg forðatöflur SIFROL 3,15 mg forðatöflur pramipexól
English: 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg three times a day
Icelandic: 1 SIFROL 0,7 mg tafla og 1 SIFROL 0,35 mg tafla þrisvar sinnum á sólarhring
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.
Icelandic: Hjá þeim sem nota levódópa er ráðlagt að minnka levódópa skammt, við upphaf meðferðar með SIFROL.
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of SIFROL prolonged-release tablets given once daily and SIFROL tablets given three times a day were equivalent.
Icelandic: I rannsókn, þar sem metnar voru pramipexól töflur og forðatöflur á fastandi maga kom í ljós að lágmarksplasmaþéttni og hámarksplasmaþéttni (Cmin, Cmax) og útsetning (AUC) var jafngild við sömu sólarhringsskammta af SIFROL forðatöflum teknar einu sinni á sólarhring og SIFROL töflum teknar 3svar á sólarhring.
English: In the absence of human data, SIFROL should not be used during breast-feeding.
Icelandic: Þar sem upplýsingar vantar fyrir menn á ekki að nota SIFROL handa konum með barn á brjósti.
English: - treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Icelandic: meðhöndlunar á einkennum miðlungs til alvarlegrar frumkominnar fótaóeirðar hjá fullorðnum.
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your SIFROL treatment.
Icelandic: á borð við þunglyndi, sinnuleysi, kvíða, þreytu, svitamyndun eða verki eftir að þú hættir eða minnkar meðferð með SIFROL.
English: In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 0.088 mg a day.
Icelandic: Í tilvikum alvarlegs nýrnasjúkdóms er venjulegur upphafsskammtur aðeins ein SIFROL 0,088 mg tafla á sólarhring.
English: SIFROL is used to: - treat the symptoms of primary Parkinson's disease in adults.
Icelandic: SIFROL er notað til: meðhöndlunar á einkennum frumkominnar Parkinsonsveiki hjá fullorðnum.
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of SIFROL should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Icelandic: á í upphafi að gefa sólarhringsskammt af SIFROL í tveimur skömmtum og byrja með 0,088 mg (0,125 mg salts) tvisvar sinnum á sólarhring (0,176 mg/0,25 mg salts á sólarhring).
English: During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):
Icelandic: Í fyrstu viku meðferðar er venjulegur skammtur ein SIFROL 0,088 mg tafla einu sinni á sólarhring (jafngildir 0,088 mg á sólarhring).
English: How to take SIFROL
Icelandic: Hvernig nota á SIFROL
English: SIFROL 0.35 mg tablets
Icelandic: SIFROL 0,35 mg töflur
English: SIFROL 0.35 mg tablets EU/1/97/050/011-012
Icelandic: SIFROL 0,35 mg töflur EU/1/97/050/011-012
English: SIFROL 2.62 mg prolonged-release tablets EU/1/97/050/031-033
Icelandic: SIFROL 2,62 mg forðatöflur EU/1/97/050/031-033
English: If you have moderate kidney disease, the usual starting dose is 1 tablet SIFROL 0.088 mg twice a day.
Icelandic: Þegar um er að ræða í meðallagi alvarlegan nýrnasjúkdóm er venjulegur upphafsskammtur ein SIFROL 0,088 mg tafla tvisvar sinnum á sólarhring.
English: Ascending dose schedule of SIFROL Week
Icelandic: Tafla með skammtaaukningu fyrir SIFROL Vika
English: SIFROL 0.088 mg tablets EU/1/97/050/001-002
Icelandic: SIFROL 0,088 mg töflur EU/1/97/050/001-002
English: The once daily administration of SIFROL prolonged-release tablets causes less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.
Icelandic: SIFROL forðatöflur einu sinni á sólarhring valda minna flökti á plasmaþéttni pramipexóls yfir 24 klst. borið saman við pramipexól töflur 3svar á sólarhring.
English: If you stop taking SIFROL
Icelandic: Ef hætt er að nota SIFROL
English: SIFROL 0.7 mg tablets EU/1/97/050/005-006
Icelandic: SIFROL 0,7 mg töflur EU/1/97/050/005-006
English: One SIFROL 0.52 mg prolonged-release tablet, OR two SIFROL 0.26 mg prolonged-release tablets.
Icelandic: Ein SIFROL 0,52 mg forðatafla EÐA tvær SIFROL 0,26 mg forðatöflur.
English: SIFROL 0.18 mg tablets
Icelandic: SIFROL 0,18 mg töflur
English: SIFROL 0.52 mg prolonged-release tablets EU/1/97/050/016-018
Icelandic: SIFROL 0,52 mg forðatöflur EU/1/97/050/016-018
English: Patients with kidney disease If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
Icelandic: Ef þú ert með alvarlegan nýrnasjúkdóm er hugsanlegt að SIFROL henti þér ekki.
English: SIFROL 0.18 mg tablets EU/1/97/050/003-004
Icelandic: SIFROL 0,18 mg töflur EU/1/97/050/003-004
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Folding box
Icelandic: Lýsing á útliti SIFROL og pakkningastærðir
English: A lower maintenance dose of one SIFROL 0.26 mg prolonged-release tablet a day is also possible.
Icelandic: Minni viðhaldsskammtur með einni 0,26 mg forðatöflu á sólarhring er einnig hugsanlegur.
English: SIFROL 0.7 mg tablets
Icelandic: SIFROL 0,7 mg töflur
English: The safety and efficacy of SIFROL prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Icelandic: á Parkinsonsveiki var metin í fjölþjóða lyfjaþróunarverkefni sem samanstóð af þremur slembuðum samanburðarrannsóknum.
English: SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Icelandic: SIFROL forðatöflur eru lyfjaform af pramipexóli til inntöku einu sinni á sólarhring.
English: Pneumonia
Icelandic: Geðrofslyf
English: - Psychosis (e.g. comparable with symptoms of schizophrenia).
Icelandic: geðveiki (t.d. sambærileg einkenni og við geðklofa).
English: MARKETING AUTHORISATION NUMBER(S) SIFROL 0.26 mg prolonged-release tablets EU/1/97/050/013-015
Icelandic: MARKAÐSLEYFISNÚMER SIFROL 0,26 mg forðatöflur EU/1/97/050/013-015
English: 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg
Icelandic: 1 SIFROL 0,35 mg tafla og 1 SIFROL 0,18 mg tafla EÐA 3 SIFROL 0,18 mg töflur
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS/ENDURNÝJUNAR
English: In advanced Parkinson's disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Icelandic: Í langt genginni Parkinsonsveiki og samsettri meðferð með levódópa, getur hreyfingatregða komið fram við skammtastillingu
English: What SIFROL looks like and contents of the pack SIFROL 0.26 mg and 0.52 mg prolonged-release tablets are white to off-white, of round shape, and have bevelled edges.
Icelandic: SIFROL 0,26 mg og 0,52 mg forðatöflur eru hvítar til beinhvítar, kringlóttar og með sniðbrún.
English: - Vision impairment.
Icelandic: Reglulegar augnskoðanir
English: SIFROL 1.05 mg prolonged-release tablets EU/1/97/050/019-021
Icelandic: SIFROL 1,05 mg forðatöflur EU/1/97/050/019-021
English: 2 tablets SIFROL 0.088 mg three times a day
Icelandic: EÐA 2 SIFROL 0,088 mg töflur þrisvar sinnum á sólarhring
English: SIFROL 0.088 mg tablets
Icelandic: SIFROL 0,088 mg töflur
English: 2 tablets SIFROL 0.18 mg three times a day
Icelandic: EÐA 2 SIFROL 0,18 mg töflur þrisvar sinnum á sólarhring
English: SIFROL 2.62 mg prolonged-release tablets
Icelandic: SIFROL 2,62 mg forðatöflur
English: SIFROL 1.57 mg prolonged-release tablets EU/1/97/050/028-030
Icelandic: SIFROL 1,57 mg forðatöflur EU/1/97/050/028-030
English: SIFROL 1.05 mg prolonged-release tablets
Icelandic: SIFROL 1,05 mg forðatöflur Pramipexól
English: SIFROL 2.1 mg prolonged-release tablets EU/1/97/050/022-024
Icelandic: SIFROL 2,1 mg forðatöflur EU/1/97/050/022-024
English: SIFROL 3.15 mg prolonged-release tablets
Icelandic: SIFROL 3,15 mg forðatöflur Pramipexól
English: 1 tablet SIFROL 0.088 mg three times a day
Icelandic: 1 SIFROL 0,088 mg tafla þrisvar sinnum á sólarhring
English: SIFROL 3.15 mg prolonged-release tablets EU/1/97/050/025-027
Icelandic: SIFROL 3,15 mg forðatöflur EU/1/97/050/025-027
English: 1 tablet SIFROL 0.35 mg three times a day OR
Icelandic: 1 SIFROL 0,35 mg tafla þrisvar sinnum á sólarhring
English: You should avoid taking SIFROL together with antipsychotic medicines.
Icelandic: Varast ber að nota SIFROL samhliða notkun geðrofslyfja.
English: Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion*
Icelandic: Hjartabilun (hjartakvillar sem geta valdið mæði eða ökklabjúg)* Óeðlileg seyting þvagstemmuvaka*
English: SIFROL 0.52 mg prolonged-release tablets
Icelandic: SIFROL 0,52 mg forðatöflur Pramipexól
English: SIFROL 1.57 mg prolonged-release tablets
Icelandic: SIFROL 1,57 mg forðatöflur Pramipexól
English: INFORMATION IN BRAILLE SIFROL 0.35 mg
Icelandic: MEÐ BLINDRALETRI SIFROL 0,35 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/016 [10 prolonged-release tablets] EU/1/97/050/017 [30 prolonged-release tablets] EU/1/97/050/018 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/016 [10 forðatöflur] EU/1/97/050/017 [30 forðatöflur] EU/1/97/050/018 [100 forðatöflur]
English: SIFROL 2.1 mg prolonged-release tablets
Icelandic: SIFROL 2,1 mg forðatöflur
English: One SIFROL 1.05 mg prolonged-release tablet, OR two SIFROL 0.52 mg prolonged-release tablets,
Icelandic: Ein SIFROL 1,05 mg forðatafla, EÐA tvær SIFROL 0,52 mg forðatöflur, EÐA fjórar SIFROL 0,26 mg forðatöflur.
English: 1 tablet SIFROL 0.18 mg three times a day OR
Icelandic: 1 SIFROL 0,18 mg tafla þrisvar sinnum á sólarhring
English: INFORMATION IN BRAILLE SIFROL 0.7 mg
Icelandic: MEÐ BLINDRALETRI SIFROL 0,7 mg
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.1 mg prolonged-release tablets Pramipexole
Icelandic: HEITI LYFS SIFROL 2,1 mg forðatöflur Pramipexól
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/025 [10 prolonged-release tablets] EU/1/97/050/026 [30 prolonged-release tablets] EU/1/97/050/027 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/025 [10 forðatöflur] EU/1/97/050/026 [30 forðatöflur] EU/1/97/050/027 [100 forðatöflur]
English: SIFROL 0.26 mg prolonged-release tablets
Icelandic: SIFROL 0,26 mg forðatöflur Pramipexól
English: 1 tablet SIFROL 0.088 mg
Icelandic: 1 SIFROL 0,088 mg tafla
English: Ascending dose schedule of SIFROL prolonged-release tablets Week Daily dose (mg of base)
Icelandic: Áætlun um hækkun á skömmtum fyrir SIFROL forðatöflur Vika Sólarhringsskammtur
English: In patients with a creatinine clearance less than 20 ml/min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Icelandic: á að gefa sólarhringsskammt af SIFROL í einum stökum skammti og byrja með 0,088 mg (0,125 mg salts) á sólarhring.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/031 [10 prolonged-release tablets] EU/1/97/050/032 [30 prolonged-release tablets] EU/1/97/050/033 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/031 [10 forðatöflur] EU/1/97/050/032 [30 forðatöflur] EU/1/97/050/033 [100 forðatöflur]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/013 [10 prolonged-release tablets] EU/1/97/050/014 [30 prolonged-release tablets] EU/1/97/050/015 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/013 [10 forðatöflur] EU/1/97/050/014 [30 forðatöflur] EU/1/97/050/015 [100 forðatöflur]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/028 [10 prolonged-release tablets] EU/1/97/050/029 [30 prolonged-release tablets] EU/1/97/050/030 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/028 [10 forðatöflur] EU/1/97/050/029 [30 forðatöflur] EU/1/97/050/030 [100 forðatöflur]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.62 mg prolonged-release tablets Pramipexole
Icelandic: SIFROL 2,62 mg forðatöflur Pramipexól
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/022 [10 prolonged-release tablets] EU/1/97/050/023 [30 prolonged-release tablets] EU/1/97/050/024 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/022 [10 forðatöflur] EU/1/97/050/023 [30 forðatöflur] EU/1/97/050/024 [100 forðatöflur]
English: Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Icelandic: Hver forðatafla inniheldur 0,375 mg pramipexól tvíhýdróklóríð einhýdrat samsvarandi 0,26 mg pramipexól.
English: Not known: - After stopping or reducing your SIFROL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Icelandic: Vart kann að verða við þunglyndi, sinnuleysi, kvíða, þreytu, svitamyndun eða verki (nefnist fráhvarfsheilkenni dópamínörva).
English: What SIFROL looks like and contents of the pack SIFROL 0.088 mg tablets are white, of round shape, flat, and without scoring.
Icelandic: SIFROL 0,088 mg töflur eru hvítar, kringlóttar, flatar og ekki með deiliskoru.
English: SIFROL 0.088 mg tablets SIFROL 0.18 mg tablets SIFROL 0.35 mg tablets SIFROL 0.7 mg tablets
Icelandic: 1 SIFROL 0,35 mg tafla EÐA 2 SIFROL 0,18 mg töflur EÐA 4 SIFROL 0,088 mg töflur
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/019 [10 prolonged-release tablets] EU/1/97/050/020 [30 prolonged-release tablets] EU/1/97/050/021 [100 prolonged-release tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/019 [10 forðatöflur] EU/1/97/050/020 [30 forðatöflur] EU/1/97/050/021 [100 forðatöflur]
English: INFORMATION IN BRAILLE SIFROL 0.18 mg
Icelandic: MEÐ BLINDRALETRI SIFROL 0,18 mg
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.7 mg tablets Pramipexole
Icelandic: SIFROL 0,7 mg töflur pramipexól
English: Gastrointestinal disorders nausea constipation vomiting
Icelandic: Tafla með skammtaaukningu fyrir SIFROL forðatöflur Vika
English: The tablets are white to off-white, of oval shape, and have a code embossed (one side with the code P12, and one side with the Boehringer Ingelheim company symbol).
Icelandic: Töflurnar eru hvítar til beinhvítar, sporöskulaga og eru með ígreyptum kóda (á annarri hliðinni er kódinn P12 og á hinni hliðinni er Boehringer Ingelheim fyrirtækistáknið).
English: 6 tablets SIFROL 0.088 mg
Icelandic: EÐA 6 SIFROL 0,088 mg töflur
English: Colloidal anhydrous silica
Icelandic: SIFROL forðataflna við meðferð
English: 4 tablets SIFROL 0.088 mg
Icelandic: MEÐ BLINDRALETRI SIFROL 0,088 mg
English: INSTRUCTIONS ON USE
Icelandic: Íhuga má notkun
English: LIST OF EXCIPIENTS
Icelandic: Lýsinga á völdum aukaverkunum
English: There is no relevant use of SIFROL in the paediatric population for the indication of Parkinson's Disease.
Icelandic: Notkun SIFROL forðataflna á ekki við hjá börnum við ábendingunni Parkinsonsveiki.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/005 [30 tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/005 [30 töflur] EU/1/97/050/006 [100 töflur]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/011 [30 tablets]
Icelandic: MARKAÐSLEYFISNÚMER EU/1/97/050/011 [30 töflur] EU/1/97/050/012 [100 töflur]
English: OR four SIFROL 0.26 mg prolonged-release tablets.
Icelandic: Ein SIFROL 0,26 mg forðatafla.
English: 400 mg Powder for concentrate for solution for infusion
Icelandic: 400 mg 3 hettuglös
English: Intravenous use vial (glass)
Icelandic: Til notkunar í bláæð hettuglasi úr gleri
English: However, on a population level, the randomised trials only showed convincing evidence of efficacy of the 10mg dose of zolpidem.
Icelandic: Slembiröðuðu rannsóknirnar sýndu aðeins fram á virkni 10 mg zolpidem.
English: It was however acknowledged that in some patients a lower dose of 5mg could be effective.
Icelandic: Minni skammturinn, 5 mg, gæti gagnast sumum sjúklingum.
English: Whereas,
Icelandic: A.
English: CMDh position
Icelandic: Fylgiseðill
English: It was therefore considered by the PRAC that the dosing recommendation should include instructions that Zolpidem is to be taken in a single intake immediately at bedtime and should not be re-administered during the same night.
Icelandic: Zolpidem á að taka í einum skammti til inntöku að kvöldi rétt fyrir svefn og ekki á að taka annan skammt sömu nótt.
English: Scientific conclusions
Icelandic: Flogaveikilyf
English: Overall conclusion
Icelandic: Minnisleysi
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Icelandic: 4.4 Sérstök varnaðarorð og varúðarreglur við notkun
English: With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness.
Icelandic: Vara skal ökumenn og stjórnendur véla við því að eins og við á um önnur svefnlyf er hugsanleg hætta á syfju, minnkuðum viðbragðsflýti, svima, svefnhöfgi, þokusýn/tvísýni og skertri árvekni og hæfni til aksturs morguninn eftir lyfjagjöf (sjá kafla 4.8).
English: Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs.
Icelandic: Dregið gæti úr árvekni Til að að lágmarka áhrifin sem talin eru upp hér fyrir framan er mælt með a.m.k. 8 klst. hvíldartíma á milli inntöku zolpidems og aksturs, notkunar véla og vinnu þar sem fallhætta er til staðar.
English: Grounds for the PRAC recommendation
Icelandic: Samantekt á eiginleikum lyfs
English: Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem.
Icelandic: Í örfáum tilvikum hefur einnig verið greint frá ofsjónum hjá sjúklingum sem taka zolpidem samhliða þunglyndislyfjum þ.á m. bupropioni, desipramini, fluoxetini, sertralini og venlafaxini.
English: Annex II
Icelandic: B.
English: The PRAC therefore agreed that the recommended daily dose of zolpidem should not be reduced for adults.
Icelandic: Nota skal minnsta virka skammt af zolpidemi og skal hann ekki vera stærri en 10 mg.
English: The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem.
Icelandic: Greint hefur verið frá minnkaðri hæfni til aksturs og atferlisskerðingu eins og „svefnakstri“ við notkun zolpidems þegar það er notað eitt sér í meðferðarskömmtum.
English: Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption.
Icelandic: Aukin bælandi áhrif á miðtaugakerfið geta komið fram við samhliðanotkun geðrofslyfja (neuroleptics), svefnlyfja, kvíðastillandi/róandi lyfja, þunglyndislyfja, sterkra verkjalyfja, flogaveikilyfja, svæfingalyfja og róandi andhistamínlyfja.
English: Overall summary of the scientific evaluation by PRAC
Icelandic: Notkun með miðtaugakerfisbælandi lyfjum
English: The analysis of the submitted individual case reports of driving ability and somnambulism showed that whatever the age and gender category, most of the cases of impaired driving were reported at a 10mg daily dose for both events.
Icelandic: Í tvíblindri, slembiraðaðri rannsókn á 462 heilbrigðum einstaklingum, sem ekki voru aldraðir, með tímabundið svefnleysi, styttu 10 mg af zolpidemi tímann sem það tók að sofna um 10 mínútur samanborið við lyfleysu, en 5 mg af zolpidemi styttu hann um 3 mínútur.
English: Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant.
Icelandic: Samhliðagjöf ciprofloxacins getur aukið þéttni zolpidems í blóði, ekki er mælt með samhliðanotkun.