FrancophonIA/ELRC3.0 huggingface dataset:
English: Ospen 0,03 mg/3 mg Filmtabletten
Icelandic: 0,03 mg/3 mg Filmtabletten
English: Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom
Icelandic: Berkshire RG14 1JA Bretland
English: MEVAREN 2/2 mg comprimidos recubiertos
Icelandic: MG/2 MG POTAHOVANÉ TABLETY
English: LEON FARMA C/ La Vallina s/n, Pol. Ind., Navatejera 24008 León Spain
Icelandic: Ind., Navatejera 24008 León Spánn
English: SANOFI AVENTIS FRANCE
Icelandic: Frakkland SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland
English: Velvian Germany GmbH
Icelandic: Augsburg Þýskaland
English: Luxembourg Teva Pharma Belgium N.V.
Icelandic: Teva Pharma Belgía N.V. Laarstraat 16
English: Albert-SchweitzerGasse 3
Icelandic: Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
English: U kabelovny 130
Icelandic: Ungverjaland Zentiva, k.s. U kabelovny 130
English: AMAROSA CONTINUOUS 3 mg 0,02 mg
Icelandic: DROSURELLE 3 mg 0,02 mg
English: Bayer Pharma AG Müllerstraße 178 D-13353 Berlin Germany
Icelandic: GmbH Wallenroder Straße 8-10 13435 Berlin Þýskaland
English: Gustav III's Boulevard
Icelandic: Esplanade du Général de Gaulle
English: 0,05 mg/ 0,035 mg 0,1 mg/ 0,03 mg 0,15 mg/ 0,03 mg
Icelandic: 0,1 mg/0,03 mg 0,15 mg/0,03 mg
English: FERRANELLES
Icelandic: Farmitalia
English: ESTINILESTRADIOL/DROS PIRENONA DIARIO ACTAVIS 0,03 mg/3 mg comprimidos recubiertos con película EFG
Icelandic: ESTINILESTRADI OL/DROSPIRENO NA DIARIO QUALITEC 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: MAITALON 3 MG/0,03 MG POTAHOVANÉ TABLETY
Icelandic: 3 MG/0,03 MG POTAHOVANÉ TABLETY
English: Yaz film coted tablets
Icelandic: Qlaira filmsko obložene tablete
English: Pharmaceuticals GmbH Raiffeisenstr.
Icelandic: Raiffeisenstr.
English: GYNDORA CONTINUOUS 3 mg 0,02 mg
Icelandic: DROSINETTA 3 mg 0,02 mg
English: DAYLLA 3 MG/0,02 MG POTAHOVANÉ TABLETY
Icelandic: Daylla 3 mg/0,02 mg filmsko obložene tablete
English: Ethinylestradiol/Drospiren on Sandoz 0,02 mg/3 mg 21 Filmtabletten
Icelandic: Ethinylestradiol/D rospirenon Sandoz 0,02 mg/3 mg 21
English: Valette Dragees
Icelandic: Ljubljana Slóvenía
English: TASMINETTA
Icelandic: Carmenelle
English: ESTINILESTRADIOL/DROS PIRENONA DIARIO ACTAVIS 0,02 mg/3 mg comprimidos recubiertos con película EFG
Icelandic: ESTINILESTRADI OL/DROSPIRENO NA DIARIO QUALITEC 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: Gestoden/ethinylestradiol 75/20 Mylan
Icelandic: Gestoden/ethinyle stradiol 75/20
English: Desogestrel/Ethinylestradi ol Actavis 150/30 microgram tabletten
Icelandic: Desogestrel/Ethin ylestradiol Actavis microgram tabletten
English: Verana-ratiopharm 2 mg/0,03 mg Filmtabletten
Icelandic: Veranaratiopharm 2 mg/0,03 mg Filmtabletten
English: ESLARILA CONTINUOUS 3 mg 0,02 mg
Icelandic: CREDIGYNETTE 3 mg 0,02 mg
English: 0.180 mg /0.035 mg 0.215 mg /0.035 mg 0.250 mg /0.035 mg
Icelandic: 0.215 mg /0.035 mg 0.25 mg /0.035 mg
English: Ovulastan Forte
Icelandic: Famy Care Europe
English: ESTINILESTRADIOL/DROS PIRENONA ACTAVIS 0,03 mg/3 mg comprimidos recubiertos con película EFG
Icelandic: ESTINILESTRADI OL/DROSPIRENO NA CINFA 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: 150 00 Praha 5
Icelandic: s r.o. Stroupežnického 17 150 00 Praha 5
English: Dropsirenone/ethinyl estradiol
Icelandic: Ethinylestradiol/g estodeen
English: 0,035 mg/0,100 mg 0,030 mg / 0,150 mg
Icelandic: 0,035 mg/0,035 mg/0,035 mg
English: Bayer PLC Pharma Division
Icelandic: Lúxemborg Mithra Pharmaceuticals S.A.
English: ESTRIENNE
Icelandic: Eistland
English: DROSETIL DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG
Icelandic: CLEOSENSA DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: Stroupežnického 17
Icelandic: Pelplińska 19
English: November 2015
Icelandic: Nóvember 2015
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 06/02/2015
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/178/001
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/14/178/001
English: Provide stability results for batch 19512 at the end of shelf life
Icelandic: Leggja fram niðurstöður varðandi stöðugleika lotu 19512 við lok geymslutíma hennar
English: Inactivated Schmallenberg virus, strain BH80/11-4
Icelandic: Óvirkjuð Schmallenberg veira, stofn BH80/11-4
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Icelandic: Ekki skal nota dýralyfið eftir fyrningardagsetningu sem tilgreind er á merkimiðanum á eftir EXP.
English: Off-white or pink liquid.
Icelandic: Gulhvítur eða bleikur vökvi.
English: * Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
Icelandic: * Undir greiningarmörkum gildaðrar RT-PCR aðferðar, sem eru 3,6 log10 RNA-eintök/ml í plasma nautgripa og 3,4 log10 RNA-eintök/ml í plasma sauðfjár.
English: Continue to develop a test to quantify saponin in the finished product and provide regular updates on results
Icelandic: Halda áfram að þróa próf til magngreiningar saponíns í tilbúnu lyfi og leggja fram uppfærðar niðurstöður reglulega
English: Intramuscular use (in the neck).
Icelandic: Gefið í vöðva (á hálsi.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Icelandic: Virka efnið sem er lífefni að uppruna og ætlað til að vekja virkt ónæmifellur utan reglugerðar (EB) nr. 470/2009.
English: Special precautions for use in animals Vaccinate only healthy animals.
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum Eingöngu á að bólusetja heilbrigð dýr.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um þetta dýralyf eru birtar á heimasíðu Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
English: To stimulate active immunity against Schmallenberg virus in cattle and sheep.
Icelandic: Til að örva virkt ónæmi gegn Schmallenberg veiru hjá nautgripum og sauðfé.
English: ATCvet code: QI02AA.
Icelandic: QI02AA.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose)
Icelandic: MAGN VIRKS INNIHALDSEFNIS/VIRKRA INNIHALDSEFNA Óvirkjuð Schmallenberg veira (RP ≥ 1/skammt)
English: ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Icelandic: ZULVAC SBV er í pappaöskju með einu hettuglasi úr háþéttnipólýetýleni (HDPE), með klóróbútýltappa og álinnsigli, sem inniheldur 50 ml af bóluefni.
English: Thiomersal
Icelandic: Thíómersal
English: No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies.
Icelandic: Engar upplýsingar liggja fyrir um notkun bóluefnisins hjá sermijákvæðum dýrum, þ.m.t. þeim sem fengið hafa mótefni frá móður.
English: Zoetis Polska Sp. z o.o.
Icelandic: Zoetis Polska Sp.
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Icelandic: 0,1 mg * RP=Hlutfallsleg virkni (Relative potency) (virknimæling í músum), í samanburði við viðmiðunarbóluefni sem sýnt hefur verið fram á að sé virkt í dýrategundinni.
English: Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months.
Icelandic: Örvunarbólusetning: gefa á tvo 2 ml skammta með þriggja vikna millibili á tólf mánaða fresti.
English: Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life
Icelandic: Leggja fram gögn sem styðja virkni rotvarnarefnisins við lok geymslutíma
English: At next commercial batch manufacture
Icelandic: Við framleiðslu næstu lotu til sölu
English: Can be used from 2 months of pregnancy and onwards.
Icelandic: Má nota frá og með 2 mánuði meðgöngu.
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Icelandic: FYRNINGARDAGSETNING EXP {mánuður/ár}
English: Aluminium hydroxide Saponin
Icelandic: Álhýdroxíð Saponín
English: Duration of immunity: 6 months after vaccination.
Icelandic: 6 mánuði eftir bólusetningu.
English: Onset of immunity: 21 days after vaccination.
Icelandic: 21 degi eftir bólusetningu.
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegra virkra efna: og framleiðenda sem eru ábyrgir fyrir lokasamþykkt:
English: Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Icelandic: Pappaaskja með einu hettuglasi úr háþéttnipólýetýleni (HDPE), með klóróbútýltappa og álinnsigli, sem inniheldur 50 ml af bóluefni.
English: Booster vaccination: - For non-breeding sheep: administer one dose of 1 ml, every 6 months.
Icelandic: - Handa sauðfé sem ekki er til undaneldis: gefa á einn 1 ml skammt á 6 mánaða fresti.
English: Amount per 1 ml dose (sheep)
Icelandic: Í 1 ml skammti (sauðfé)
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made by the veterinary surgeon on a case by case basis.
Icelandic: Ákvörðun um notkun þessa bóluefnis fyrir eða eftir notkun einhvers annars dýralyfs skal því tekin af dýralækni í hverju tilviki fyrir sig.
English: Zoetis Hellas S.A.
Icelandic: Zoetis Hellas S.A. Τηλ.:
English: Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Icelandic: - Handa nautgripum frá 3,5 mánaða aldri: gefa á tvo 2 ml skammta með þriggja vikna millibili.
English: Amount per 2 ml dose (cattle)
Icelandic: Í 2 ml skammti (nautgripir)
English: Shake the vial before use.
Icelandic: Hristið hettuglasið fyrir notkun.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle:
Icelandic: SKAMMTAR FYRIR HVERJA DÝRATEGUND, ÍKOMULEIÐ(IR)
English: The reactions may last for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.
Icelandic: 47 daga, sem dreifður þroti, innan við 2 cm í þvermál.
English: The reactions may persist for at least 97 days in the form of small granules of less than 0.5 cm of diameter.
Icelandic: 97 daga, sem litlir hnútar, innan við 0,5 cm í þvermál.
English: - For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.
Icelandic: - Handa ám til undaneldis: gefa á einn 1 ml skammt a.m.k 14 dögum fyrir hvert fang.
English: Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep.
Icelandic: Fyrirliggjandi eru gögn sem sýna fram á öryggi bóluefnisins þegar það er gefið lambfullum ám.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Icelandic: Bólusetning sauðfjár til undaneldis fyrir fang, samkvæmt ráðlagðri bólusetningaráætlun sem lýst er í kafla 4.9, dregur úr veirublóðsýkingu* og sýkingum yfir fylgju, af völdum Schmallenberg veiru á fyrsta þriðjungi meðgöngu.
English: Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml.
Icelandic: - Handa sauðfé frá 3,5 mánaða aldri: gefa á einn 1 ml skammt.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 8 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Icelandic: Bólusetning sauðfjár til undaneldis fyrir fang, samkvæmt ráðlagðri bólusetningaráætlun sem lýst er í kafla 8, dregur úr veirusmiti í blóði* og sýkingum yfir fylgju, sem tengjast sýkingu af völdum Schmallenberg veiru á fyrsta þriðjungi meðgöngu.
English: In cattle, a transient increase in rectal temperature, not exceeding 1.5 °C, may very commonly occur during the 48 hours following vaccination.
Icelandic: Hjá nautgripum er mjög algengt að fram komi tímabundin hækkun á hita í endaþarmi, sem ekki nemur meira en 1,5ºC, á fyrstu 48 klukkustundum eftir bólusetningu.
English: In pregnant ewes, a transient increase in rectal temperature, not exceeding 0.8 ºC, may very commonly occur during the first 4 hours after vaccination.
Icelandic: Hjá lambfullum ám er mjög algengt að fram komi tímabundin hækkun á hita í endaþarmi, sem ekki nemur meira en 0,8ºC, á fyrstu 4 klukkustundum eftir bólusetningu.
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu lyfið Ef sá sem annast lyfjagjöf sprautar sig með dýralyfinu fyrir slysni skal tafarlaust leita til læknis og hafa meðferðis fylgiseðil eða umbúðir dýralyfsins.
English: ROUTE(S) OF ADMINISTRATION IM (cattle)
Icelandic: ÍKOMULEIÐ(IR) i.m. (nautgripir) s.c. (sauðfé)
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter, which resolve in a maximum of 10 days.
Icelandic: Mjög algengt er að staðbundin viðbrögð komi fram hjá bólusettum dýrum, sem litlir hnútar í vöðva, allt að 0,7 cm í þvermál, sem hverfa af sjálfu sér eftir að hámarki 10 daga.
English: In sheep, a transient increase in rectal temperature, not exceeding 1.5 ºC, may very commonly occur during the first 24 hours after vaccination.
Icelandic: Hjá sauðfé er mjög algengt að fram komi tímabundin hækkun á hita í endaþarmi, sem ekki nemur meira en 1,5ºC, á fyrstu 24 klukkustundum eftir bólusetningu.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum:
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Icelandic: 12 mánuðir eftir lok frumbólusetningar.
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures: Description
Icelandic: Markaðsleyfishafi skal ljúka eftirfarandi innan tilgreindra tímamarka:
English: Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm.
Icelandic: Mjög algengt er að staðbundin viðbrögð komi fram hjá bólusettum dýrum, sem dreifður þroti eða hnútar undir húð, að hámarki 8 cm í þvermál.
English: Zoetis Spain, S.L.
Icelandic: Zoetis Spain, S.L. Tel:
English: For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Icelandic: Til virkrar ónæmingar hjá sauðfé frá 3,5 mánaða aldri til að minnka veirusmit í blóði* sem tengist sýkingu af völdum Schmallenberg veiru.
English: PACKAGE LEAFLET FOR: ZULVAC SBV suspension for injection for cattle and sheep
Icelandic: FYLGISEÐILL FYRIR: ZULVAC SBV stungulyf, dreifa, fyrir nautgripi og sauðfé
English: Subcutaneous use (in the axillar region behind the elbow).
Icelandic: Til notkunar undir húð (á síðu, aftan við bóg).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Icelandic: INNRI UMBÚÐUM Hettuglas (50 ml)
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
Icelandic: Ónæmislyf fyrir slíðurhyrninga (Bovidae).
English: Sheep:
Icelandic: Sauðfé:
English: Provide batch records for a second batch of finished product manufactured according to the dossier
Icelandic: Leggja fram gögn um aðra lotu tilbúins lyfs sem framleitt er samkvæmt lýsingum í gögnum um lyfið
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections
Icelandic: Kalíumklóríð Kalíum díhýdrógenfosfat
English: Onset of immunity: 14 days after completion of the primary vaccination course.
Icelandic: 14 dögum eftir lok frumbólusetningar.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep
Icelandic: HEITI DÝRALYFS ZULVAC SBV stungulyf, dreifa, fyrir nautgripi og sauðfé
English: For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Icelandic: Til virkrar ónæmingar hjá nautgripum frá 3,5 mánaða aldri til að draga úr veirublóðsýkingu* af völdum Schmallenberg veiru.
English: Zoetis Finland Oy Sími: +358 (0)9 4300 40
Icelandic: Oy Sími: +358 (0)9 4300 40
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Icelandic: SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN C. UPPLÝSINGAR
English: Cattle: The safety and efficacy of the vaccine has not been established in pregnant cattle.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun bóluefnisins hjá kálffullum kúm.
English: Lactation: The safety and the efficacy of the vaccine have not been established in lactating animals.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun bóluefnisins hjá mjólkandi dýrum.
English: Suomi/Finland Zoetis Finland Oy Puh/Tel: +358 (0)9 4300 40
Icelandic: Oy Puh/Tel: +358 (0)9 4300 40
English: ADVICE ON CORRECT ADMINISTRATION Shake the vial before use.
Icelandic: LYFJAGJÖF Hristið hettuglasið fyrir notkun.
English: Shelf life after first opening the container: use immediately.
Icelandic: Geymsluþol eftir að umbúðir hafa verið rofnar:
English: Due date
Icelandic: Núll dagar
English: Cattle:
Icelandic: Mjólkurgjöf:
English: Excipient: Thiomersal
Icelandic: A. ÁLETRANIR
English: Sheep: subcutaneous use.
Icelandic: Sauðfé: til notkunar undir húð.
English: Magyarország Zoetis Hungary Kft. Tel: +361 224 5222
Icelandic: Luxembourg/Luxemburg Zoetis Belgium SA Tél/Tel.: +352 8002 4026
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Icelandic: VIÐAUKI I SAMANTEKT Á EIGINLEIKUM LYFS
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Icelandic: INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Virkt innihaldsefni:
English: On a regular basis
Icelandic: Reglulega
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: 2 (2 x 1) vials + 2 (2 x 1) syringes +2 (2 x 1) needles + 2 (2 x 1) vial adapters + 4 (2 x 2) alcohol pads (multipack)
Icelandic: 0,8 ml (40 mg/0,8ml) 2 (2 x 1) hettuglös + 2(2 x 1) sprautur + 2(2 x 1) nálar + 2(2 x 1) sæft millistykki + 4(2 x 2) sprittþurrkur (fjölpakkning)
English: Content (concentration)
Icelandic: (Sér) heiti
English: 1 vial + 1 syringe + 1 needle + 1 vial adapter + 2 alcohol pads
Icelandic: + 1 sprauta + 1 nál + 1 sæft millistykki + 2 sprittþurrkur
English: 1 pre-filled syringe + 2 alcohol pads
Icelandic: 0,8 ml (40 mg/0,8ml) 1 áfylltur penni + 2 sprittþurrkjur
English: (see section 4.4).
Icelandic: (Sjá einnig kafla 4.4).
English: 2 years
Icelandic: 2ár.
English: • Urge to behave in an unusual way
Icelandic: Þörf fyrir að hegða sér á óvenjulegan hátt*
English: Each blister strip contains 10 tablets.
Icelandic: Í hverju þynnuspjaldi eru 10 töflur.
English: North Harrow, Middx HA1 4HF United Kingdom
Icelandic: North Harrow, Middx HA1 4HF Bretland
English: Date of latest renewal: 15th July 2016
Icelandic: 15 Júlí 2016
English: A total of 63 patients were randomised (43 on pramipexole, 20 on placebo).
Icelandic: Samtals 63 sjúklingum var slembiraðað (43 á pramipexóli, 20 á lyfleysu).
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið við lægri hita en 30C.
English: Approximately 90% of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Icelandic: Um 90% af 14C-merktum skammti skilst út um nýru en minna en 2% finnst í hægðum.
English: 7 OTHER SPECIAL WARNING(S), IF NECESSARY
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF
English: All the strengths of Pramipexole Accord tablets are available in alu-alu blisters of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Icelandic: Allir styrkleikar af Pramipexole Accord töflum eru fáanlegir í ál/ál þynnum sem innihalda 10 töflur hver og í öskjum sem innihalda 3 eða 10 þynnuspjöld (30 eða 100 töflur).
English: Pramipexole Accord can cause hallucinations (seeing, hearing or feeling things that are not there).
Icelandic: Pramipexole Accord getur valdið ofskynjunum (maður sér, heyrir eða finnur fyrir einhverju sem er ekki til staðar).
English: - Strong impulse to gamble excessively despite serious personal or family consequences.
Icelandic: Sterkar skyndihvatir til að stunda fjárhættuspil þrátt fyrir alvarlegar afleiðingar fyrir þig eða fjölskylduna.
English: Nausea and fatigue were more often reported in female patients treated with Pramipexole Accord (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Icelandic: Ógleði og þreyta komu oftar fram hjá konum sem meðhöndlaðar voru með Pramipexole Accord (20,8% og 10,5%, talið í sömu röð) samanborið við karla (6,7% og 7,3%, talið í sömu röð).
English: The tablet can be divided into two equal doses.
Icelandic: Töflunum má skipta í tvo jafna skammta.
English: 1 This side effect has been observed in post-marketing experience.
Icelandic: 1 Þessi aukaverkun hefur komið fram eftir markaðssetningu.
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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: Aukaverkanir eru taldar upp innan líffæraflokka eftir tíðni (fjöldi sjúklinga líklegir til að fá aukaverkun) samkvæmt eftirfarandi skilgreiningu: 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: No difference was observed for pramipexole as compared to placebo for either the primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or Clinical Global Impressions of Severity of Illness (CGI-S).
Icelandic: Engin munur sást fyrir pramipexól borið saman við lyfleysu hvorki hvað varðar aðalendapunkt né aðra aukaendapunkta, þar á meðal YGTSS heildarskor, PGI-I (Patient Global Impression of Improvement), CGI-I (Clinical Global Impression of Improvement) og CGI-S (Clinical Global Impressions of Severity of Illness).
English: The leaflet was last revised in {MM/YYYY}.
Icelandic: Þessi fylgiseðill var síðast uppfærður {MM/ÁÁÁÁ}.
English: Pramipexole Accord can reduce the production of breast milk.
Icelandic: Pramipexole Accord getur minnkað mjólkurmyndun.
English: Pramipexole Accord can be taken with or without food.
Icelandic: Pramipexole Accord má taka með eða án matar.
English: Your doctor will then discuss with you if you should continue to take Pramipexole Accord.
Icelandic: Læknirinn mun ræða við þig um hvort ráðlegt sé að halda áfram að taka Pramipexole Accord.