FrancophonIA/ELRC3.0 huggingface dataset:
English: To be used within 6 weeks of first opening of the tray.
Icelandic: Notið innan 6 vikna frá því að bakkinn með innöndunartækinu er opnaður.
English: Other medicines and Rolufta Ellipta
Icelandic: Notkun annarra lyfja samhliða Rolufta Ellipta
English: It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm.
Icelandic: Það skal ekki notað gegn bráðum einkennum, t.d. sem bráðalyf til meðferðar við bráðum berkjukrampa.
English: If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Icelandic: Ef blísturshljóð við öndun eða mæði koma fram skaltu nota innöndunartæki með skjótvirku lyfi (svo sem salbútamóli) og leita síðan ráða hjá lækni.
English: Rolufta Ellipta contains lactose
Icelandic: Rolufta Ellipta inniheldur laktósa
English: b) How to inhale the medicinal product
Icelandic: b) Hvernig á að anda lyfinu inn
English: How to use Rolufta Ellipta
Icelandic: Hvernig nota á Rolufta Ellipta
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL LAMINATE TRAY LID
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNA Á LOKI LAGSKIPTS BAKKA
English: The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Icelandic: Heildaraðgengi umeclidiniumbrómíðs við innöndun var að meðaltali 13% af skammtinum, en frásog frá meltingarvegi var hverfandi.
English: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Icelandic: + 44 (0)800 221441 customercontactuk@gsk.com
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Icelandic: Þegar innöndunartækið er tekið úr bakkanum er það lokað.
English: Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Icelandic: Ólíklegt er talið að klínískt mikilvægar milliverkanir komi fram fyrir tilstilli umeclidiniumbrómíðs við notkun ráðlagðra skammta vegna lágrar plasmaþéttni við notkun innöndunarskammta.
English: Patients receiving Rolufta Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Icelandic: Hlutfall daga þar sem ekki var þörf fyrir bráðalyf var hærra (að meðaltali 31,1%) hjá sjúklingum sem fengu
English: Rolufta Ellipta 55 mcg inhalation powder umeclidinium (umeclidinium bromide)
Icelandic: Rolufta Ellipta 55 míkrógrömm innöndunarduft umeclidinium (umeclidiniumbrómíð)
English: It is packaged in a foil laminate tray with a peelable foil lid.
Icelandic: Því er pakkað inn í lagskiptan álbakka með þynnuloki sem fletta má af.
English: When the tray is opened, write the “Discard by” date on the inhaler label in the space provided.
Icelandic: Þegar bakkinn hefur verið opnaður skaltu skrá „Fargist“ dagsetninguna
English: GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk.com
Icelandic: + 31 (0)30 6938100 nlinfo@gsk.com
English: Rolufta Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Icelandic: Rolufta Ellipta skal ekki nota við skyndilegri mæði eða blísturshljóðum við öndun.
English: GlaxoSmithKline AB
Icelandic: GlaxoSmithKline AB Tel:
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium bromide to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Icelandic: Í rannsóknum sem gerðar voru fyrir og eftir fæðingu með gjöf umeclidiniumbrómíðs undir húð hjá rottum, kom fram minni þyngdaraukning og minni neysla fæðu hjá mæðrum og svolítið minni þyngd unga áður en þeir voru vandir af spena hjá kvendýrum sem fengu 180 míkróg/kg/dag (u.þ.b.
English: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Icelandic: ГлаксоСмитКлайн ЕООД Teл.: + 359 2 953 10 34
English: It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes.
Icelandic: Það er kínuclidínafleiða, sem er múskarínviðtakablokki sem er virkur á ýmsar undirtegundir múskarínvirkra kólínviðtaka.
English: A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p<0.001) in the 24-week study.
Icelandic: Sýnt var fram á tölfræðilega marktækan bata samanborið við lyfleysu á TDI-mælikvarðanum í viku 24 fyrir Rolufta Ellipta (1,0 stig; p<0,001) í 24 vikna rannsókninni.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide.
Icelandic: Áhrif á hjarta og æðar, svo sem hjartsláttartruflanir t.d. gáttatif og hraðtaktur, geta komið fram eftir gjöf múskarínviðtakablokka þ.m.t. umeclidiniumbrómíðs.
English: Other antimuscarinics
Icelandic: Önnur andmúskarínlyf
English: What Rolufta Ellipta looks like and contents of the pack
Icelandic: Lýsing á útliti Rolufta Ellipta og pakkningastærðir
English: The inhaler should be held away from the mouth breathing out as far as is comfortable.
Icelandic: Haltu innöndunartækinu langt frá munninum og andaðu eins vel frá þér og þú getur með góðu móti.
English: Your Rolufta Ellipta inhaler carton contains
Icelandic: Askjan með Rolufta Ellipta innöndunartækinu inniheldur
English: There is no relevant use of Rolufta Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Icelandic: Notkun Rolufta Ellipta á ekki við hjá börnum yngri en 18 ára við ábendingunni langvinnri lungnateppu.
English: Cardiovascular effects
Icelandic: óreglulegur hjartsláttur
English: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
Icelandic: + 370 5 264 90 00 info.lt@gsk.com
English: Rare side effects
Icelandic: Mjög sjaldgæfar aukaverkanir
English: Similarly, a greater proportion of patients achieved at least the MCID for Rolufta Ellipta at Week 24 (44%) compared with placebo (34%) in the 24-week study.
Icelandic: MCID fyrir Rolufta Ellipta í viku 24 (44%) samanborið við lyfleysu (34%) í 24 vikna rannsókninni.
English: Inhalation powder, pre-dispensed (inhalation powder).
Icelandic: Innöndunarduft, afmældir skammtar (innöndunarduft).
English: Rolufta Ellipta is for inhalation use.
Icelandic: Rolufta Ellipta er til innöndunar.
English: Umeclidinium bromide is intended for the maintenance treatment of COPD.
Icelandic: Umeclidiniumbrómíð er ætlað til viðhaldsmeðferðar við langvinnri lungnateppu.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest skal hafa samband við lækninn áður en lyfið er notað.
English: How to store Rolufta Ellipta
Icelandic: Hvernig geyma á Rolufta Ellipta
English: The Ellipta inhaler consists of a grey plastic body, a light green mouthpiece cover and a dose counter.
Icelandic: Ellipta innöndunartækið samanstendur af gráum meginhluta, ljósgrænu loki yfir munnstykkið og skammtateljara.
English: Supporting efficacy studies
Icelandic: Stuðningsrannsóknir á verkun
English: United Kingdom or
Icelandic: Bretland eða
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR)
English: The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p<0.001*) at Week 24.
Icelandic: eftir gjöf skammts miðað við lyfleysu var að meðaltali 130 ml (p<0,001*) í viku
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
Icelandic: 12 mánuðum var meðferð með flútíkasónfúróati/umeclidiniumi/vílanteróli (FF/UMEC/VI 99/55/22 míkróg) einu sinni á dag í einu innöndunartæki borin saman við flútíkasónfúróat/vílanteról (FF/VI 99/22 míkróg) einu sinni á dag í einu innöndunartæki.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
Icelandic: Hver stök innöndun gefur skammt (skammt sem fer í gegnum munnstykkið) sem er 55 míkróg af umeclidinium (jafngildir 65 míkróg af umeclidiniumbrómíði).
English: Not known Not known Not known Rare
Icelandic: Tíðni ekki þekkt Tíðni ekki þekkt Tíðni ekki þekkt Mjög sjaldgæfar
English: Desiccant
Icelandic: Skammtar
English: This will allow quick identification of new safety information.
Icelandic: Þetta lyf er undir sérstöku eftirliti til að nýjar upplýsingar um öryggi lyfsins komist fljótt og örugglega til skila.
English: Posology
Icelandic: UPPLÝSINGAR
English: Similarly, a greater proportion of patients achieved ≥1 unit TDI focal score for Rolufta Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study.
Icelandic: Rolufta Ellipta (53%) samanborið við lyfleysu (41%) í viku 24 í 24 vikna rannsókninni.
English: Effects on lung function
Icelandic: Áhrif á lungnastarfsemi
English: Allergic reactions
Icelandic: Ofnæmisviðbrögð
English: Pharyngitis
Icelandic: Fargist:
English: In a Phase III, 6-month study (DB2113373) Rolufta Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p<0.001*).
Icelandic: Í 6 mánaða III. stigs rannsókn (DB2113373) kom fram klínískt mikilvægur bati á lungnastarfsemi við notkun Rolufta Ellipta miðað við lyfleysu (mældur sem útöndunarrúmmál á 1 sekúndu [FEV1] á 24 klst.
English: The tray can be discarded after first opening.
Icelandic: Farga má bakkanum eftir að hann hefur verið opnaður.
English: Breathlessness:
Icelandic: Fylgiseðill:
English: In both of the pivotal 12-week and 24-week studies, Rolufta Ellipta demonstrated statistically significant and clinically meaningful improvements in lung function (as defined by change from baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint in each study) compared with placebo (see Table 1).
Icelandic: Í bæði 12 vikna og 24 vikna lykilrannsóknum var sýnt fram á tölfræðilega marktækan og klínískt mikilvægan bata í lungnastarfsemi með Rolufta Ellipta samanborið við lyfleysu (sjá töflu 1) (bati skilgreindur sem breyting
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Icelandic: Skylda til aðgerða eftir útgáfu markaðsleyfis
English: • infection of nose and throat
Icelandic: særindi í hálsi
English: Acute symptoms should be treated with an inhaled short-acting bronchodilator.
Icelandic: Bráð einkenni skal meðhöndla með skjótvirku berkjuvíkkandi lyfi.
English: Cough
Icelandic: Sundl
English: Infections and infestations
Icelandic: LYFJAFORM OG INNIHALD
English: GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com
Icelandic: + 43 (0)1 97075 0 at.info@gsk.com
English: Pregnancy and breast-feeding
Icelandic: Meðganga og brjóstagjöf
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Icelandic: Rolufta Ellipta 55 míkróg innöndunarduft, afmældir skammtar
English: UNIQUE IDENTIFIER - 2D BARCODE
Icelandic: 17. EINKVÆMT AUÐKENNI - TVÍVÍTT STRIKAMERKI
English: Inhalation powder, pre-dispensed.
Icelandic: Innöndunarduft, afmældir skammtar.
English: Carton
Icelandic: Verkun
English: • Increase of the measured eye pressure
Icelandic: Aukning á mældum augnþrýstingi.
English: Other side effects
Icelandic: Aðrar aukaverkanir
English: MARKETING AUTHORISATION HOLDER
Icelandic: MARKAÐSLEYFISNÚMER
English: Write the date the inhaler should be thrown away on the label in the space provided.
Icelandic: Skráið daginn sem farga skal lyfinu, í rýmið sem til þess er ætlað á miðanum.
English: In use shelf-life: 6 weeks.
Icelandic: Geymsluþol eftir að notkun er hafin: 6 vikur.
English: Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide)
Icelandic: Rolufta Ellipta 55 míkrógrömm innöndunarduft, afmældir skammtar umeclidinium (umeclidiniumbrómíð)
English: A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p<0.001∗) in the 24-week study.
Icelandic: 24 samanborið við lyfleysu (-4,69 stig, p<0,001∗) í 24 vikna rannsókninni.
English: Rolufta Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.
Icelandic: Einnig var sýnt fram á að Rolufta Ellipta bætti tölfræðilega marktækt heilsutengd lífsgæði mæld samkvæmt SGRQ (St. George's Respiratory Questionnaire) sem kemur fram sem lækkun á heildarskori samkvæmt
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Icelandic: Lyf gegn teppusjúkdómum í öndunarvegi, andkólínvirk lyf, ATC-flokkur:
English: Reproductive toxicity
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: PHARMACEUTICAL FORM
Icelandic: LYFJAFRÆÐILEGAR
English: Store in the original package in order to protect from moisture.
Icelandic: Geymið við lægri hita en 30°C. Geymið í upprunalegum umbúðum til varnar gegn raka.
English: The tray contains a desiccant sachet, to reduce moisture.
Icelandic: Bakkinn inniheldur poka af þurrkefni til að minnka raka.
English: • cough
Icelandic: • kvef
English: INSTRUCTIONS ON USE
Icelandic: Við notkun
English: This leaflet was last revised in Other sources of information
Icelandic: Þessi fylgiseðill var síðast uppfærður <{MM/ÁÁÁÁ}> <í {mánuður ÁÁÁÁ}>.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Icelandic: 4.2 Skammtar og lyfjagjöf
English: System Organ Class
Icelandic: Líffæraflokkur
English: Check with your doctor or pharmacist if you are not sure.
Icelandic: - Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum.
English: INFORMATION IN BRAILLE
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Icelandic: Geymið ekki við hærri hita en 30°C. Ef lyfið er geymt í kæli skal það fá að ná stofuhita í a.m.k. eina klukkustund fyrir notkun.
English: Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray.
Icelandic: Nota má lyfið í allt að 6 vikur eftir að bakkinn er opnaður.
English: Excipients
Icelandic: Útbrot
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 12 was greater for Rolufta Ellipta 55 micrograms (44%) compared with placebo (26%) in the 12-week study.
Icelandic: 12 var hærra fyrir Rolufta Ellipta 55 míkróg (44%) samanborið við lyfleysu (26%) í 12 vikna rannsókninni.
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Icelandic: Útskilnaður lyfjatengdra efna í hægðum eftir gjöf í bláæð benti til seytingar út í gall.
English: Hepatic impairment
Icelandic: Hægðatregða Munnþurrkur
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Icelandic: + 45 36 35 91 00 dk-info@gsk.com
English: Inhalation use
Icelandic: Taugakerfi
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Icelandic: VIÐAUKI III ÁLETRANIR OG FYLGISEÐILL
English: Elderly
Icelandic: Aldraðir
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum eða lyfjafræðingi.
English: Wait to open the cover until you are ready to inhale your dose.
Icelandic: Ekki opna lokið fyrr en þú er tilbúin/n til anda að þér skammtinum.
English: See section 4.
Icelandic: Tafla 1:
English: - This medicine has been prescribed for you only.
Icelandic: - Þessu lyfi hefur verið ávísað til persónulegra nota.
English: • faster heart beat
Icelandic: hraðari hjartsláttur
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Icelandic: Þetta samsvarar afmældum skammti sem er 62,5 míkróg af umeclidiniumi sem jafngildir 74,2 míkróg af umeclidiniumbrómíði.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Icelandic: SKULI GEYMT ÞAR SEM BÖRN HVORKI NÁ TIL NÉ SJÁ
English: • Dizziness
Icelandic: INNIHALDSLÝSING
English: Read the package leaflet before use.
Icelandic: Einu sinni á dag Lesið fylgiseðilinn fyrir notkun.
English: By Q3 2024
Icelandic: R03BB07.
English: Biotransformation
Icelandic: LYFJAFORM
English: Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-week pivotal study.
Icelandic: Tölfræðilega marktækt meiri bati miðað við grunngildi kom fram með Rolufta Ellipta í vegnu meðaltali FEV1 0-6 klst. eftir notkun skammts í viku
English: Package leaflet: Information for the user Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed umeclidinium (umeclidinium bromide) This medicine is subject to additional monitoring.
Icelandic: Upplýsingar fyrir notanda lyfsins Rolufta Ellipta 55 míkrógrömm innöndunarduft, afmældir skammtar umeclidinium (umeclidiniumbrómíð)
English: This breath should be held in for as long as possible (at least 3-4 seconds).
Icelandic: 3-4 sekúndur).
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Icelandic: OG SKILYRÐI MARKAÐSLEYFIS •
English: Due date
Icelandic: Tímamörk
English: Antimuscarinic activity
Icelandic: Glaxo Operations
English: Eye disorders
Icelandic: Aukinn augnþrýstingur Augnverkur
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: Nervous system disorders
Icelandic: Ónæmiskerfi
English: Eye problems during treatment with Rolufta Ellipta
Icelandic: Augnvandamál meðan á meðferð með Rolufta Ellipta stendur
English: An updated RMP should be submitted:
Icelandic: Leggja skal fram uppfærða áætlun um áhættustjórnun:
English: Metabolic and transporter based interactions
Icelandic: Milliverkanir tengdar umbrotum og ferjum
English: Fertility
Icelandic: Ltd
English: • sore throat
Icelandic: Þurrkefni Bakki
English: NAME OF THE MEDICINAL PRODUCT
Icelandic: NAFN MARKAÐSLEYFISHAFA
English: Inhalation use.
Icelandic: MEÐ BLINDRALETRI
English: Renal impairment
Icelandic: Algengar aukaverkanir
English: Animal studies indicate no effects of umeclidinium bromide on fertility.
Icelandic: Dýrarannsóknir benda ekki til þess að umeclidiniumbrómíð hafi áhrif á frjósemi.
English: See package leaflet for further information
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: 28 patches (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
Icelandic: 28 forðaplástrar (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)
English: Annex A
Icelandic: VIÐAUKI A
English: PE/Alu/ ET copolymer/paper)
Icelandic: 84 (2 x 42) forðaplástrar (fjölpakkning k)
English: Cipla Europe Nv
Icelandic: Cipla Europe
English: Sandoz Hungária Kft
Icelandic: Ungverjaland Sandoz Hungária Kft
English: Intravenous Use |
Icelandic: Intraarticular Use |
English: United Kingdom Cipla (Eu) Limited
Icelandic: Cipla (Eu) Limited
English: Belgium Pfizer S.A. (Belgium)
Icelandic: Pfizer S.A. (Belgium)
English: Group Srl
Icelandic: S.F. Group Srl
English: United Kingdom Hameln Pharmaceuticals Ltd Methotrexate Hameln
Icelandic: Hameln Pharmaceuticals Ltd Methotrexate Hameln
English: Metotrexato Doc Generici
Icelandic: Doc Generici
English: Austria
Icelandic: Austurríki
English: Netherlands Teva Nederland B.V.
Icelandic: Teva Nederland B.V.
English: United Kingdom Pfizer Limited
Icelandic: Pfizer Limited
English: Latvia
Icelandic: Lettland
English: Methotrexate Sodium 1.097g Vial
Icelandic: Metotrexát Sodium 1.097g Vial
English: Teva Pharma - Produtos Farmacêuticos Lda
Icelandic: - Produtos Farmacêuticos Lda
English: France
Icelandic: Frakkland
English: Film-Coated Tablet
Icelandic: Filmuhúðuð tafla
English: Ireland
Icelandic: Írland
English: Metoject Pen
Icelandic: Метожект Pen
English: Italy
Icelandic: Ítalía
English: Belgium Sandoz N.V.
Icelandic: Sandoz N.V.
English: Greece
Icelandic: Grikkland
English: United Kingdom Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)
Icelandic: Für Klinische Spezialpräparate Mbh (Wedel)
English: Finland
Icelandic: Finnland
English: Methotrexate Sodium 1.097g/10ml
Icelandic: Metotrexát Sodium 1.097g/10ml
English: Methotrexate Sodium 10.968mg/1.33ml
Icelandic: Metotrexát Sodium 10.968mg/1.33ml
English: Iceland
Icelandic: Ísland
English: Netherlands Centrafarm B.V.
Icelandic: Centrafarm B.V.
English: Lithuania
Icelandic: Litháen
English: Bulgaria
Icelandic: Búlgaría
English: Methotrexate Sodium 21.936mg/2.66ml
Icelandic: Metotrexát Sodium 21.936mg/2.66ml
English: Methotrexate Disodium 1096.8mg
Icelandic: Disodium 1096.8mg
English: Methotrexate 0.6ml/30mg
Icelandic: Metotrexát 0.6ml/30mg
English: Metotrexato Wyeth Methotrexate Sodium 1g/40ml
Icelandic: Wyeth Metotrexát Sodium 1g/40ml
English: Methotrexate 100mg Vial
Icelandic: Metotrexát 100mg Vial
English: Netherlands Mylan B.V.
Icelandic: Mylan B.V.
English: Hospira Uk Ltd
Icelandic: Uk Ltd
English: Methotrexate Disodium 1096mg Vial
Icelandic: Disodium 1096mg Vial
English: Methotrexat Ebewe Methotrexate Disodium 10.97mg/Ml
Icelandic: Methotrexat Ebewe Metotrexát Disodium 10.97mg/Ml
English: Methotrexate Disodium 27.41mg Vial
Icelandic: Disodium 27.41mg Vial
English: Methotrexate 5mg Vial
Icelandic: 5mg Vial
English: Metotrexato Wyeth Methotrexate Sodium 5g/200ml
Icelandic: Wyeth Metotrexát Sodium 5g/200ml
English: Spain
Icelandic: Spánn
English: Luxembourg Pfizer S.A. (Belgium)
Icelandic: Lúxemborg Pfizer S.A. (Belgium)
English: Methotrexate 5g/50ml
Icelandic: Metotrexát 5g/50ml
English: Methotrexate Disodium 27.41mg/Ml
Icelandic: Metotrexát Disodium 27.41mg/Ml
English: Methotrexate Disodium 16.44mg/0.6ml
Icelandic: Metotrexát Disodium 16.44mg/0.6ml
English: Intravenous Use
Icelandic: Parenteral Use
English: Methotrexaat Teva Methotrexate 17.5mg/0.7ml
Icelandic: Methotrexaat Teva Metotrexát 17.5mg/0.7ml
English: Methotrexate Disodium 10.96mg Vial
Icelandic: Disodium 10.96mg Vial
English: Methotrexate Disodium 21.92mg/0.8ml
Icelandic: Disodium 21.92mg/0.8ml
English: Methotrexate Disodium 16.44mg Vial
Icelandic: Disodium 16.44mg Vial
English: Methotrexate Sodium 16.452mg/2ml
Icelandic: Metotrexát Sodium 16.452mg/2ml
English: Methotrexate 0.55ml/27.5mg
Icelandic: Metotrexát 0.55ml/27.5mg
English: Methotrexate 1g/40ml
Icelandic: Metotrexát 1g/40ml
English: Methotrexate 100ml/Ml
Icelandic: Metotrexát 100ml/Ml
English: Methotrexate 1g/10ml
Icelandic: Metotrexát 1g/10ml
English: Metotrexato Accord Methotrexate 1000mg/10ml
Icelandic: Metotrexato Accord Metotrexát 1000mg/10ml
English: Methotrexate Sodium 5.484g/50ml
Icelandic: Metotrexát Sodium 5.484g/50ml
English: Methotrexate Disodium 5483.7mg
Icelandic: Disodium 5483.7mg
English: Methotrexate Disodium 10.96mg/0.4ml
Icelandic: Disodium 10.96mg/0.4ml