FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Icelandic: Vitað er að notkun angíótensín-II blokka á öðrum og þriðja þriðjungi meðgöngu hefur skaðleg áhrif á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og skaðleg áhrif á nýbura (nýrnabilun, lágþrýstingur, blóðkalíumhækkun).
English: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
Icelandic: Örkristallaður sellulósi Kroskarmellósnatríum
English: What Irbesartan Teva looks like and contents of the pack
Icelandic: Útlit Irbesartan Teva og pakkningastærðir
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9 %), hypotension (2.2 %), dizziness (1.9 %), cough (0.9 %).
Icelandic: Höfuðverkur (7,9%), lágþrýstingur (2,2%), sundl (1,9%), hósti (0,9%).
English: In 1.7 % of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Icelandic: Lækkun hemóglóbíns*, sem ekki skipti máli klínískt, kom fram hjá 1,7% sjúklinga með háþrýsting sem voru með langt gengna sykursýki með nýrnasjúkdómi og voru á irbesartan meðferð.
English: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2 %) and the placebo groups (56.5 %).
Icelandic: Í samanburðarrannsókn með lyfleysu hjá sjúklingum með of háan blóðþrýsting var heildartíðni aukaverkana sambærileg hjá þeim sem fengu irbesartan (56,2%) og hjá þeim sem fengu lyfleysu
English: if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - aliskiren
Icelandic: o ACE hemil (til dæmis enalapríl, lisinopríl, ramipríl) sérstaklega ef þú ert með nýrnakvilla sem tengjast sykursýki o aliskiren
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Icelandic: Ósæðar- og míturlokuþrengsli, ofvaxtarhjartavöðvakvilli með teppu (obstructive hypertrophic cardiomyopathy):
English: No dose adjustment is necessary in patients with impaired renal function.
Icelandic: Ekki er nauðsynlegt að breyta skömmtum hjá sjúklingum með skerta nýrnastarfsemi.
English: Each film-coated tablet contains 150 mg irbesartan
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg af irbesartani.
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan
Icelandic: Irbesartan Teva 75 mg filmuhúðaðar töflur
English: tinnitus
Icelandic: Pólland
English: Irbesartan Teva 150 mg film-coated tablets
Icelandic: Irbesartan Teva 150 mg filmuhúðaðar töflur
English: Respiratory, thoracic and mediastinal disorders Uncommon: cough
Icelandic: Öndunarfæri, brjósthol og miðmæti Sjaldgæfar:
English: Povidone
Icelandic: Verkunarháttur
English: No dosage adjustment is necessary in elderly people.
Icelandic: Ekki þarf að breyta skömmtum hjá öldruðum.
English: How to take Irbesartan Teva
Icelandic: Irbesartan Teva
English: Irbesartan Teva 300 mg film-coated tablets
Icelandic: Irbesartan Teva 300 mg Filmuhúðaðar töflur
English: Package leaflet: information for the user Irbesartan Teva 150 mg Film-Coated Tablets
Icelandic: Upplýsingar fyrir notanda lyfsinsIrbesartan Teva 150 mg filmuhúðaðar töflur
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Icelandic: Lyf við of háum blóðþrýstingi, sem verka með því að hemja renín-angíótensín-kerfið, verka að öllu jöfnu ekki á sjúklinga með aldósterónheilkenni.
English: EU/1/09/576/025 50 x 1 tablet (unit dose) EU/1/09/576/026 56 x 1 tablet (unit dose) EU/1/09/576/041 28 tablets (calendar pack)
Icelandic: EU/1/09/576/026 56 x 1 tafla (stakskammta)
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Icelandic: Við samtímis gjöf litíums og ACE-hemla hefur orðið vart hækkunar á litíumgildum í sermi, sem gekk til baka, og eiturverkana.
English: If you take more Irbesartan Teva than you should
Icelandic: Ef stærri skammtur en mælt er fyrir um er tekinn af Irbesartan Teva
English: EU/1/09/576/038 50 x 1 tablet (unit dose) EU/1/09/576/039 56 x 1 tablet (unit dose) EU/1/09/576/042 28 tablets (calendar pack)
Icelandic: EU/1/09/576/039 56 x 1 tafla (stakskammta)
English: Diuretics and other antihypertensive agents
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR
English: If you suffer from kidney problems
Icelandic: Ef þú ert með nýrnasjúkdóm
English: EU/1/09/576/012 50 x 1 tablet (unit dose) EU/1/09/576/013 56 x 1 tablet (unit dose) EU/1/09/576/040 28 tablets (calendar pack)
Icelandic: EU/1/09/576/013 56 x 1 tafla (stakskammta)
English: Contents of the pack and other information What Irbesartan Teva contains
Icelandic: Irbesartan Teva Pakkningar og arar upplýsingar
English: Excipient
Icelandic: Frásog
English: How to store Irbesartan Teva
Icelandic: „Ekki má nota Irbesartan Teva”
English: If you take more Irbesartan Teva than you should:
Icelandic: Áður en byrjað er að nota Irbesartan Teva Ekki má taka Irbesartan Teva:
English: Irbesartan Teva 150 mg film-coated tablets Irbesartan
Icelandic: Irbesartan Teva 150 mg Filmuhúðaðar töflur
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5 %) and elevated CK values in 2 % of child recipients.
Icelandic: Hækkuð gildi kreatíníns (6,5%) og hækkuð gildi kreatínkínasa (CK) hjá 2% barna, sem fengu lyfið.
English: Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Icelandic: Hraður hjartsláttur, andlitsroði, hósti, niðurgangur, meltingartruflanir/nábítur, truflanir á kyngetu og verkur fyrir brjósti.
English: Uncommon: sexual dysfunction
Icelandic: Lifrarbólga, óeðlileg lifrarstarfsemi
English: In patients with high blood pressure and type 2 diabetes with kidney disease,
Icelandic: Hjá 1.715 háþrýstingssjúklingum með sykursýki af gerð 2, próteinmigu
English: Teva Pharma Belgium N.V./S.A/AG Tél/Tel: +32 38207373
Icelandic: N.V./S.A/AG Tél/Tel:
English: What is in this leaflet
Icelandic: Hvað inniheldur
English: When irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Icelandic: Mælt er með að mæla kalíum- og kreatíníngildi í sermi reglulega, þegar irbesartan er notað hjá sjúklingum með skerta nýrnastarfsemi.
English: C.
Icelandic: Hg.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor immediately.
Icelandic: Ef þú heldur að þú sért að fá slík einkenni eða mæði kemur fram skaltu hætta töku
English: Tablet Core:
Icelandic: Blóðkalíumhækkun:
English: Cardiac disorders Uncommon: tachycardia Vascular disorders Common:
Icelandic: (open-label period), sáust oftast eftirfarandi óeðlilegar rannsóknaniðurstöður:
English: hyperkalaemia Nervous system disorders Common:
Icelandic: Meltingarfæri Algengar:
English: 4 (4 x 1) vials (multipack)
Icelandic: Til notkunar í bláæð hettuglasi (gler) 4 (4 x 1) hettuglösum (fjölpakkning)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Icelandic: ESB markaðsleyfisnúmer (Sér) heiti
English: Immediate Packaging
Icelandic: Innriumbúðir Pakkningastærð
English: * RP - relative potency (ELISA).
Icelandic: * RP, hlutfallsleg virkni (relative potency) (ELISA)
English: Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Icelandic: Svínum frá 6 mánaða aldri sem ekki hafa verið bólusett áður með lyfinu skal gefa tvo skammta með 3 - 4 vikna millibili.
English: Date of first authorisation: 08/07/2014 Date of latest renewal:
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 08/07/2014
English: Allow the vaccine to reach room temperature (15-25 ºC) before administration.
Icelandic: Leyfið bóluefninu að ná stofuhita (15-25°C) áður en það er gefið.
English: Revaccination should be performed prior to each gestation, see section 4.9.
Icelandic: Endurbólusetning skal fara fram fyrir hverja meðgöngu, sjá kafla 4.9.
English: A single injection should be given 2-3 weeks prior to each subsequent mating (approximately every 6 months).
Icelandic: Gefa skal einn skammt 2-3 vikum fyrir hverja pörun (á u.þ.b. 6 mánaða fresti).
English: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN
Icelandic: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial
English: The second injection should be administered 3-4 weeks before mating.
Icelandic: Seinni skammtinn skal gefa 3-4 vikum fyrir pörun.
English: LABORATORIOS HIPRA, S.A. Avda.
Icelandic: LABORATORIOS HIPRA, S.A.
English: Shelf life after mixing with UNISTRAIN PRRS: 2 hours.
Icelandic: Geymsluþol eftir blöndun við UNISTRAIN PRRS: 2 klst.
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a 2-fold vaccine dose.
Icelandic: Engar aukaverkanir aðrar en þær sem getið er í kafla 4.6 sáust eftir gjöf á tvöföldum skammti bóluefnisins.
English: 17170 Amer (Girona) SPAIN
Icelandic: Amer (Girona) SPÁNN
English: Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Icelandic: - Væg eða í meðallagi væg bólga á stungustað sem oftast hverfur innan fjögurra daga en getur í sumum tilfellum varað í allt að 12 daga frá bólusetningu sást í rannsóknum á öryggi lyfsins.
English: 10 doses
Icelandic: 10 skammtar
English: ERYSENG PARVO suspension for injection for pigs
Icelandic: ERYSENG PARVO stungulyf, dreifa fyrir svín
English: HIPRA SLOVENSKO, s.r.o.
Icelandic: Slovenská republika HIPRA SLOVENSKO, s.r.o.
English: 25 doses
Icelandic: 25 skammtar
English: Disodium phosphate dodecahydrate Ginseng
Icelandic: Tvínatríumfosfatdódekahýdrat Ginseng
English: Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients.
Icelandic: Gefið ekki dýrum sem hafa ofnæmi fyrir virku efnunum, ónæmisglæðunum eða einhverju hjálparefnanna.
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Icelandic: Gefið einn skammt af 2 ml með inndælingu í hálsvöðva í samræmi við eftirfarandi áætlun:
English: Revaccination should be performed prior to each gestation, refer to section “Dosage for each species, route(s) and method of administration”.
Icelandic: Endurbólusetning skal fara fram fyrir hverja meðgöngu, sjá kaflann „Skammtar fyrir hverja dýrategund, íkomuleið(ir) og aðferð við lyfjagjöf“.
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Icelandic: Til virkrar ónæmingaraðgerðar hjá göltum og gyltum til að draga úr einkennum (sárum á húð og hita) rauðsýki (swine erysipelas) af völdum Erysipelothrix rhusiopathiae, sermigerð 1 og sermigerð 2.
English: 50 doses
Icelandic: 50 skammtar
English: Aluminium hydroxide DEAE-dextran
Icelandic: DEAE-Dextran
English: For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.
Icelandic: Til virkrar ónæmingaraðgerðar hjá gyltum til að vernda afkvæmin fyrir sýkingu yfir fylgju af völdum svína-parvóveiru.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), see section 4.9.
Icelandic: Bólusetning verndar gegn rauðsýki fram til þess tíma sem mælt er með endurbólusetningu (u.þ.b. sex mánuðum eftir grunnbólusetningu), sjá kafla 4.9.
English: 10 doses (20 ml) 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Icelandic: 10 skammtar (20 ml) 25 skammtar (50 ml) 50 skammtar (100 ml) 125 skammtar (250 ml)
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site.
Icelandic: Fyrirliggjandi eru gögn sem sýna fram á öryggi og virkni þegar þessu bóluefni er blandað saman við UNISTRAIN PRRS (þar sem það bóluefni er með markaðsleyfi) og gefið á sama inndælingarstað.
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.
Icelandic: Bólusetning verndar gegn rauðsýki fram til þess tíma sem mælt er með endurbólusetningu (u.þ.b. sex mánuðum eftir grunnbólusetningu), sjá kafla „Skammtar fyrir hverja dýrategund, íkomuleið(ir) og aðferð við lyfjagjöf“.
English: A single dose (2 ml) of the mixed vaccines should be injected within a period of 2 hours via intramuscular use.
Icelandic: Gefa skal einn skammt (2 ml) af blöndunni með inndælingu í vöðva innan 2 klukkustunda.
English: Do not mix with any other veterinary medicinal product, except with UNISTRAIN PRRS.
Icelandic: Ekki má blanda þessu dýralyfi saman við nein önnur dýralyf, nema UNISTRAIN PRRS.
English: No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose.
Icelandic: Ekki er búist við öðrum aukaverkunum en þeim sem þegar hafa verið nefndar í kaflanum „Aukaverkanir“ eftir gjöf á tvöföldum skammti af bóluefni.
English: Polyethylene (PET) bottles of 20, 50, 100 and 250 ml.
Icelandic: Pólýetýlen (PET) glös, 20, 50, 100 og 250 ml.
English: + 10 doses (20 ml)
Icelandic: + 10 skammtar (20 ml)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Icelandic: LÍFFRÆÐILEGRA VIRKRA EFNA OG FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: + 50 doses (100 ml)
Icelandic: + 50 skammtar (100 ml)
English: Common adverse reactions: - A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours was observed in safety studies.
Icelandic: - Tímabundin hækkun líkamshita innan fyrstu 6 klst eftir bólusetningu sem hverfur sjálfkrafa innan 24
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Icelandic: Leitið ráða hjá dýralækni um hvernig heppilegast er að farga lyfjum sem hætt er að nota.
English: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Icelandic: Ef sá sem annast lyfjagjöf sprautar sig með dýralyfinu fyrir slysni skal tafarlaust leita til læknis og hafa meðferðis fylgiseðil eða umbúðir dýralyfsins.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Icelandic: Ekki liggja fyrir neinar upplýsingar um öryggi og verkun þessa bóluefnis við samtímis notkun neins annars dýralyfs öðru en því sem tilgreint er hér að framan.
English: For simultaneous use with UNISTRAIN PRRS in sows for reproduction from 6 months of age, the mixed administration of ERYSENG PARVO and UNISTRAIN PRRS should only be used when vaccinating animals prior to mating.
Icelandic: Við notkun samtímis UNISTRAIN PRRS hjá gyltum til undaneldis eldri en 6 mánaða, ætti aðeins að gefa blöndu af ERYSENG PARVO og UNISTRAIN PRRS þegar dýrin eru bólusett fyrir pörun.
English: 10 doses (20 ml) 25 doses (50 ml)
Icelandic: 10 skammtar (20 ml) 25 skammtar (50 ml)
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) Bottles (100 ml, 250 ml) and vials (100 ml)
Icelandic: YTRI UMBÚÐUM OG INNRI UMBÚÐUM Pappaaskja, (20 ml, 50 ml, 100 ml, og 250 ml) Glös (100ml, 250ml) og hettuglös (100 ml)
English: The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.
Icelandic: Blöndu af UNISTRAIN PRRS og ERYSENG PARVO ætti aðeins að nota við bólusetningu dýra fyrir pörun.
English: + 25 doses (50 ml)
Icelandic: + 25 skammtar (50 ml)
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated viral and bacterial vaccines.
Icelandic: Óvirkjuð veirubóluefni og óvirkjuð bakteríubólefni.
English: Cardboard box with 1 PET bottle of 125 doses (250 ml).
Icelandic: Pappaaskja með 1 PET glasi með 125 skömmtum (250 ml).
English: Major incompatibilities: Do not mix with any other veterinary medicinal product except with UNISTRAIN PRRS.
Icelandic: Ekki má blanda þessu dýralyfi saman við nein önnur dýralyf nema UNISTRAIN PRRS.
English: Interaction with other medicinal products and other forms of interaction: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site.
Icelandic: Fyrirliggjandi eru gögn sem sýna fram á um öryggi og virkni þegar þessu bóluefni er blandað saman við UNISTRAIN PRRS (þar sem það bóluefni er með markaðsleyfi) og gefið á sama inndælingarstað.
English: Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Icelandic: - Greint hefur verið frá bráðaofnæmisviðbrögðum eftir markaðssetningu og ráðlagt er að veita viðeigandi meðferð gegn einkennum.
English: Name and address of the manufacturers of the biological active substances:
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegra virkra efna
English: E. rhusiopathiae: three weeks after completion of the basic vaccination scheme.
Icelandic: Þremur vikum eftir lok grunnbólusetningar.
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP > 1.15 * Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%** * RP - relative potency (ELISA).
Icelandic: Óvirkjuð svína-parvóveira, stofn NADL-2, ............................................................ RP> 1,15 * Óvirkjuð Erysipelothrix rhusiopathiae, stofn R32E11, .................ELISA > 3,34 log2 IE50 %** * RP (relative potency) (ELISA) ** IE50% „inhibition“ ELISA - 50%
English: Inactivated porcine parvovirus, strain NADL-2, ..................................................... RP* > 1.15, Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .............. ELISA > 3.34 log2 IE50%**
Icelandic: Óvirkjuð svína-parvóveira, stofn NADL-2, ............................................................ RP> 1,15 * Óvirkjuð Erysipelothrix rhusiopathiae, stofn R32E11, ................ELISA > 3,34 log2 IE50 % **
English: For mixed use, the onset and duration of immunity of the parvovirus component and the onset of immunity of the Erysipelas component have been demonstrated to be equivalent to those determined for ERYSENG PARVO when used alone.
Icelandic: Þegar bóluefnin eru notuð samanblönduð hefur verið sýnt fram á að upphaf og ending ónæmis fyrir parvovírus-þættinum og upphaf ónæmis fyrir erysipelas-þættinum séu jafngild því þegar ERYSENG PARVO er notað eitt og sér.
English: However, the duration of immunity of the Erysipelas component following mixed use has not been investigated.
Icelandic: Aftur á móti hefur ending ónæmis fyrir erysipelas-þættinum eftir notkun í blöndu ekki verið rannsökuð.
English: Porcine parvovirus: vaccination provides foetal protection for the duration of gestation.
Icelandic: Bólusetningin veitir fóstri vernd á meðgöngunni.
English: The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO.
Icelandic: Leysa skal innihald í einu hettuglasi af UNISTRAIN PRRS upp með innihaldinu úr einu hettuglasi af ERYSENG PARVO.
English: HIPRA BENELUX NV Tel: (+32) 09 2964464
Icelandic: Luxembourg/Luxemburg HIPRA BENELUX NV Tel: (+32) 09 2964464
English: Cardboard box with 1 PET bottle of 10 doses (20 ml).
Icelandic: Pappaaskja með 1 PET glasi með 10 skömmtum (20 ml).
English: The product information of UNISTRAIN PRRS should be consulted before administration of the mixed products.
Icelandic: Athuga skal samantekt á eiginleikum lyfs um UNISTRAIN PRRS áður en blanda þessara tveggja bóluefna er gefin með inndælingu.
English: Cardboard box with 1 PET bottle of 25 doses (50 ml).
Icelandic: Pappaaskja með 1 PET glasi með 25 skömmtum (50 ml).
English: Potassium chloride Potassium dihydrogen phosphate Simethicone
Icelandic: Stungulyf, dreifa Hvítleitt stungulyf
English: Cardboard box with 1 PET bottle of 50 doses (100 ml).
Icelandic: Pappaaskja með 1 PET glasi með 50 skömmtum (100 ml).
English: Special precautions for use in animals: None.
Icelandic: Sérstakar varúðarreglur við notkun hjá dýrum:
English: Aluminium hydroxide ..................................................................................... 5.29 mg (aluminium) DEAE-Dextran
Icelandic: Álhýdroxíð 5,29 mg (ál)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles, (20 ml, 50 ml) and vials (20 ml, 50 ml)
Icelandic: INNRI UMBÚÐUM Glös (20 ml, 50 ml), hettuglös (20 ml, 50 ml)
English: Cardboard box with 1 glass vial of 10 doses (20 ml).
Icelandic: Pappaaskja með 1 hettuglasi með 10 skömmtum (20 ml).
English: Basic vaccination:
Icelandic: Grunnbólusetning:
English: To stimulate active immunisation against porcine parvovirus and swine erysipelas.
Icelandic: QI09AL01 Til að örva virkt ónæmi gegn svína-parvóveiru og rauðsýki.
English: Name and address of the manufacturer responsible for batch release:
Icelandic: Markaðsleyfishafi og framleiðandi sem ber ábyrgð á lokasamþykkt:
English: At any time:
Icelandic: Hvenær sem er:
English: Do not stop taking IBRANCE unless your doctor tells you to.
Icelandic: Ekki hætta að taka IBRANCE nema læknirinn gefi þér fyrirmæli um það.
English: Your doctor will tell you how many capsules of IBRANCE to take.
Icelandic: Læknirinn þinn mun segja þér hve mörg hylki af IBRANCE þú þarft að taka.
English: IBRANCE with food and drink
Icelandic: IBRANCE með mat og drykk
English: If you have taken too much IBRANCE, see a doctor or go to a hospital immediately.
Icelandic: Ef þú hefur tekið of mikið af IBRANCE skaltu leita læknis eða fara á sjúkrahús tafarlaust.
English: Urgent treatment may be necessary.
Icelandic: Bráð læknismeðferð kann að vera nauðsynleg.
English: Grading according to CTCAE 4.0.
Icelandic: Stig samkvæmt CTCAE 4.0.
English: Swallow the capsule whole with a glass of water.
Icelandic: Hylkin á að gleypa í heilu lagi með glasi af vatni.
English: Take the carton and this leaflet, so that the doctor knows what you have been taking.
Icelandic: Taktu umbúðirnar og þennan fylgiseðil með svo læknirinn viti hvaða lyf þú hefur verið að taka.
English: *If further dose reduction below 75 mg/day is required, discontinue the treatment.
Icelandic: *Ef þörf er á frekari skammtaminnkun undir 75 mg/dag skal hætta meðferð.
English: Do not open the capsules.
Icelandic: Ekki má opna hylkin.
English: Tell your healthcare provider right away if you have any new or worsening symptoms including:
Icelandic: Láttu heilbrigðisstarfsmann strax vita ef þú ert með ný eða versnandi einkenni sem eru meðal annars:
English: 75 mg/day*
Icelandic: 75 mg/dag*
English: Day 15 of first 2 cycles:
Icelandic: Dagur 15 í fyrstu 2 meðferðarlotum: