FrancophonIA/ELRC3.0 huggingface dataset:
English: • cotton ball or gauze pad
Icelandic: • bómullarhnoðra eða grisju
English: Guide to parts
Icelandic: Útskýringar á hlutum Fyrir notkun
English: Higher rates of fungal infections, primarily non-serious skin and mucosal candida infections, were observed in Kyntheum patients compared to placebo patients, 1.8% vs 0.9%, respectively.
Icelandic: Kyntheum fengu oftar sveppasýkingar heldur en þeir sjúklingar sem fengu lyfleysu, eða 1,8% í samanburði við 0,9%.
English: Injection site reactions (including injection site erythema, pain, pruritus, bruising, haemorrhage)
Icelandic: Viðbrögð á stungustað (þar með talið roði á stungustað, verkur, kláði, mar, blæðing)
English: • Do not twist or bend the grey needle cap. • Do not put the grey needle cap back onto the syringe.
Icelandic: Ekki snúa upp á eða beygja gráu nálarhettuna.
English: As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.
Icelandic: Til öryggis ætti að forðast notkun Kyntheum á meðgöngu.
English: Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity.
Icelandic: Í klínískum rannsóknum hafa verið gefnir skammtar allt að 700°mg í bláæð án skammtatakmarkandi eiturhrifa.
English: During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.8% of patients treated with Kyntheum compared with 0.5% of patients treated with placebo.
Icelandic: Meðan á 12 vikna klínískum samanburðarrannsóknum með lyfleysu stóð var greint frá tilfellum daufkyrningafæðar hjá 0,8% sjúklinga sem fengu Kyntheum, samanborið við 0,5% sjúklinga sem fengu lyfleysu.
English: In moderate to severe plaque psoriasis patients following a single subcutaneous administration of Kyntheum at 210 mg, the mean maximum serum concentration (Cmax) was 13.4 mcg/ml (standard deviation [SD] = 7.29 mcg/ml).
Icelandic: Hjá sjúklingum með meðalslæman til mjög slæman skellupsóríasis var meðaltal hámarksþéttni í sermi (Cmax) 13,4 mcg/ml (staðalfrávik = 7,29 mcg/ml) eftir staka gjöf Kyntheum 210 mg undir húð.
English: Patients randomised to ustekinumab received 45 mg for patients ≤100 kg and 90 mg for patients >100 kg at Weeks 0, 4, and 16 followed by same dose every 12 weeks.
Icelandic: 45 mg ef þeir voru ≤100 kg og 90 mg ef þeir voru >100 kg í viku 0, 4 og 16, og eftir það fengu þeir sama skammt á 12 vikna fresti.
English: At Week 12, patients originally randomised to Kyntheum who achieved sPGA success (0 or 1) were re-randomised to receive either placebo or continued Kyntheum at their induction dose.
Icelandic: 12 var aftur slembiraðað til að fá annaðhvort lyfleysu eða til að halda áfram að fá Kyntheum í sama skammti og í innleiðslufasanum.
English: Kyntheum 210 mg injection brodalumab
Icelandic: Kyntheum 210 mg stungulyf bródalúmab s.c.
English: Renal or hepatic impairment
Icelandic: þunglyndi, kvíða eða geðsveiflur
English: The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
Icelandic: Ráðlagður skammtur er 210 mg til inndælingar undir húð í viku 0, 1 og 2, að því loknu skal gefa 210 mg á tveggja vikna fresti.
English: Important: Keep the skin pinched until after you have injected.
Icelandic: Haltu húðinni samanklemmdri þar til inndælingu er lokið.
English: Carcinogenicity studies with brodalumab have not been conducted.
Icelandic: Engar rannsóknir hafa farið fram á krabbameinsvaldandi áhrifum bródalúmabs.
English: Across treatment groups, the baseline Psoriasis Area Severity Index (PASI) score ranged from 9.4 to 72 (median: 17.4)
Icelandic: Yfir meðferðarhópinn var upphafsgildi mælikvarða á útbreiðslu og alvarleika psóríasis (e. Psoriasis Area Severity Index, PASI) á bilinu 9,4 til 72 (miðgildi: 17,4) og upphafsgildi líkamsyfirborðs sem var undir áhrifum sjúkdómsins var á bilinu 10 til 97 (miðgildi:
English: F. Pinch your skin to create a firm surface
Icelandic: Klemmdu húðina saman til að búa til stinnt svæði til inndælingar
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kyntheum therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með Kyntheum.
English: Infections Kyntheum may increase the risk of infections.
Icelandic: Sýkingar Kyntheum getur aukið líkur á sýkingum.
English: Table 1: List of adverse reactions in clinical trials System Organ Class
Icelandic: Listi yfir aukaverkanir í klínískum rannsóknum
English: Important: Always hold the pre-filled syringe by the syringe barrel.
Icelandic: Alltaf skal halda á áfylltu sprautunni með því að halda utan um sprautuhólkinn.
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, lyfjafræðingi eða hjúkrunarfræðingnum.
English: Important: Always keep the sharps disposal container out of the sight and the reach of children.
Icelandic: Geymdu ílátið fyrir oddhvassa hluti ávallt þar sem börn hvorki ná til né sjá.
English: Serum concentrations in monkey infants and in foetal rabbits indicated considerable passage of brodalumab from the mother to the foetus at the end of pregnancy.
Icelandic: öpum og hjá kanínufóstrum benti til þess að bródalúmab fari í verulegu magni yfir fylgju í lok meðgöngu.
English: In cynomolgus monkeys there were no effects on male and female reproductive organs and on sperm count, motility and morphology following administration of brodalumab at dose levels up to 90 mg/kg once weekly for 6 months, (AUC exposure up to 47-fold higher than in human patients receiving Kyntheum 210 mg every 2 weeks).
Icelandic: Engin áhrif voru á æxlunarfæri kven- og karlkyns cynomolgus-apa, einnig voru engar breytingar á fjölda sæðisfrumna, hreyfanleika þeirra og lögun eftir gjöf bródalúmabs í skömmtum allt að 90 mg/kg einu sinni í viku í 6 mánuði (heildarútsetning (AUC) 47 sinnum hærri en hjá mönnum sem fengu Kyntheum 210 mg á 2 vikna fresti).
English: SC
Icelandic: PC:
English: Uncommon Candida infections (including oral, genital, and oesophageal infections)
Icelandic: Candida-sýkingar (þ.m.t. sýkingar í munni, kynfærum og vélinda)
English: • Put your used pre-filled syringe in a puncture resistant sharps disposal container straight after use.
Icelandic: Settu notuðu áfylltu sprautuna í ílát fyrir oddhvassa hluti strax eftir notkun.
English: Kyntheum can be kept at room temperature up to 25°C in the outer carton for 14 days.
Icelandic: Kyntheum má geyma í ytri umbúðum við stofuhita allt að 25°C í 14 daga.
English: No cases of active tuberculosis were reported from clinical trials.
Icelandic: Í klínískum rannsóknum var ekki tilkynnt um nein tilvik af virkum berklum.
English: Plunger
Icelandic: Dreifing
English: No dose adjustment is recommended.
Icelandic: Ekki er mælt með skammtaaðlögun.
English: Do not try to inject Kyntheum until you or your caregiver have been shown how to inject Kyntheum by your doctor or nurse.
Icelandic: Kyntheum fyrr en þú eða umönnunaraðili þinn hefur fengið leiðbeiningar frá lækni eða hjúkrunarfræðingi um inndælingu Kyntheum.
English: • tiredness
Icelandic: A. ÁLETRANIR
English: Population pharmacokinetic modelling indicated that age did not have an effect on brodalumab pharmacokinetics, which was co-based on 259 (6%) patients being 65-74 years old and on 14 (0.3%)
Icelandic: Lyfjahvarfalíkan af þýðinu gaf til kynna að aldur hafi ekki áhrif á lyfjahvörf bródalúmabs sem byggðist bæði á niðurstöðum um 259 (6%) sjúklinga á aldrinum 65-74 ára og 14 (0,3%) sjúklinga á aldrinum ≥75 ára, í heildarþýðislíkaninu sem náði yfir 4.271 sjúklinga með skellupsóríasis.
English: Other side effects that have been reported Common side effects (may affect up to 1 in 10 people):
Icelandic: Algengar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum):
English: The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Icelandic: Kyntheum sem gefið er samhliða ónæmisbælandi lyfjum, þar á meðal líftæknilyfjum, eða ljósameðferð, hefur ekki verið metið.
English: Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Icelandic: Greining á útsetningu og svörun bendir til að hærri þéttni bródalúmabs tengist betri svörun hvað varðar mælikvarða á útbreiðslu og alvarleika psóríasis (PASI) og heildarmati læknis á ákveðnum tímapunkti (sPGA).
English: C.
Icelandic: F.
English: Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
Icelandic: Ekki er mælt með því að breyta skömmtum handa öldruðum sjúklingum (sjá kafla 5.2).
English: Instructions for Use: Kyntheum (brodalumab) Solution for injection in pre-filled syringe
Icelandic: Kyntheum (bródalúmab) Stungulyf, lausn í áfylltri sprautu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA FYRIR STAKAR PAKKNINGAR
English: The trial included a 12-week double-blind, placebocontrolled induction phase followed by a double-blind withdrawal and retreatment phase up to 52 weeks.
Icelandic: Rannsóknin fól í sér 12 vikna tvíblindan innleiðslufasa með lyfleysusamanburði, í kjölfar þess var allt að 52 vikna tvíblint fráhvarfs- og endurmeðhöndlunartímabil.
English: Serious infections occurred in 0.5% of patients treated with Kyntheum and in 0.2% of patients treated with placebo.
Icelandic: 0,5% sjúklinga sem fengu Kyntheum og 0,2% sjúklinga sem fengu lyfleysu fengu alvarlegar sýkingar.
English: Throw the needle cap into the sharps disposal container provided.
Icelandic: Fleygðu nálarhettunni í meðfylgjandi ílát undir oddhvassa hluti.
English: Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Icelandic: Kyntheum er ætlað til meðferðar á meðalslæmum eða slæmum skellupsóríasis hjá fullorðnum sem taldir eru þola altæka lyfjameðferð.
English: Subcutaneous use
Icelandic: Notaður stimpill
English: Exercise caution when prescribing Kyntheum to patients with a history of Crohn's disease.
Icelandic: Fylgjast ætti með einkennum um virkan Crohns-sjúkdóm hjá sjúklingum með sögu um Crohns-sjúkdóm.
English: Solution for injection (injection) The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles.
Icelandic: Stungulyf, lausn (stungulyf) Lausnin er tær eða aðeins ópallýsandi, litlaus eða aðeins gulleit og laus við agnir.
English: Based on population pharmacokinetic modelling the estimated half-life of brodalumab was 10.9 days at steady-state after every other week subcutaneous dose of 210 mg.
Icelandic: Áætlaður helmingunartími bródalúmabs var 10,9 dagar við jafnvægi eftir gjöf 210 mg undir húð aðra hvora viku, byggt á lyfjahvarfalíkani af þýðinu.
English: Kyntheum 210 mg solution for injection in pre-filled syringe brodalumab
Icelandic: Kyntheum 210 mg stungulyf, lausn í áfylltri sprautu bródalúmab
English: Both trials included a 12-week double-blind, placebo- and ustekinumab-controlled induction phase followed by a double-blind maintenance phase up to 52 weeks.
Icelandic: Báðar rannsóknirnar fólu í sér 12 vikna tvíblindan innleiðslufasa með lyfleysusamanburði og samanburði við ústekínúmab, í kjölfar þess var allt að 52 vikna tvíblindur viðhaldsfasi.
English: Oropharyngeal pain
Icelandic: • sprittþurrkur
English: Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles.
Icelandic: Kyntheum er tær eða aðeins ópallýsandi, litlaus eða aðeins gulleit lausn og laus við agnir.
English: Neutropenia
Icelandic: Inflúensa
English: • if you have recently received or are scheduled to receive a vaccination.
Icelandic: ef þú hefur nýlega fengið bólusetningu eða ef bólusetning er fyrirhuguð.
English: Based on population pharmacokinetic modelling, the estimated accumulation ratio after 20 weeks of dosing is 2.5-fold.
Icelandic: Áætlað uppsöfnunarhlutfall eftir skammta í 20 vikur er 2,5-falt, byggt á lyfjahvarfalíkani af þýðinu.
English: 1.5 ml solution.
Icelandic: 5.1 Lyfhrif
English: To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting.
Icelandic: 30 mínútur áður en lyfið er gefið með inndælingu til að forðast óþægindi á stungustað.
English: Immediately tell your doctor or seek medical help if you get any signs of a serious infection.
Icelandic: Ef þú færð einhver merki um alvarlega sýkingu skaltu strax láta lækninn þinn vita eða leita læknishjálpar.
English: • Do not inject into an area of the skin that is tender, bruised, red, hard or in an area of skin that is affected by psoriasis.
Icelandic: Ekki dæla í svæði þar sem húðin er aum, marin, rauð, hörð eða þar sem merki eru um psóríasis.
English: • if you have a long-term (chronic) infection
Icelandic: ef þú ert með langvinna (króníska) sýkingu
English: Renal elimination of intact brodalumab, an IgG monoclonal antibody, is expected to be low and of minor consequence.
Icelandic: Brotthvarf óumbrotins bródalúmabs, einstofna IgG-mótefnis, gegnum nýru, er talið vera lítið og skipta litlu máli.
English: Thigh
Icelandic: Algengar
English: • Avoid injecting directly into raised, thick, red or scaly skin patches or lesions.
Icelandic: Forðastu að dæla beint í húðsvæði sem eru upphleypt, þykknuð, rauð eða í hreistraða bletti eða sár.
English: Based on population pharmacokinetic modelling, the estimated mean steady-state volume of distribution of brodalumab was approximately 7.24 L.
Icelandic: Áætlað meðaldreifingarrúmmál bródalúmabs við jafnvægi var um það bil 7,24 l, byggt á lyfjahvarfalíkani af þýðinu.
English: For single use only
Icelandic: Til notkunar undir húð Eingöngu einnota
English: What Kyntheum looks like and contents of the pack
Icelandic: Lýsing á útliti Kyntheum og pakkningastærðir
English: Arthralgia Myalgia
Icelandic: Grá nálarhetta á
English: Step 1: Preparing A. Remove the Kyntheum pre-filled syringe from the box
Icelandic: Undirbúningur A. Fjarlægðu
English: Using your Kyntheum pre-filled syringe
Icelandic: Kyntheum áfylltu sprautuna úr öskjunni
English: Most adverse reactions of Kyntheum-associated neutropenia observed were mild, transient and reversible.
Icelandic: Þegar um var að ræða daufkyrningafæð af völdum Kyntheum voru aukaverkanirnar oftast vægar, skammvinnar og afturkræfar.
English: Self-administration instructions
Icelandic: 15. NOTKUNARLEIÐBEININGAR
English: Comprehensive instructions for administration are given in the package leaflet.
Icelandic: Ítarlegar leiðbeiningar um lyfjagjöf eru í fylgiseðlinum.
English: The pre-filled syringe must not be shaken.
Icelandic: Ekki má hrista áfylltu sprautuna.
English: • Do not hold the plunger.
Icelandic: Ekki halda um stimpilinn.
English: At Week 12, patients in the ustekinumab group continued to receive ustekinumab and then were switched to Kyntheum 210 mg every 2 weeks at Week 52.
Icelandic: Í 12. viku fengu sjúklingar í ústekínúmab-hópnum áfram ústekínúmab og í viku
English: Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles.
Icelandic: Kyntheum er tær eða örlítið gljáandi stungulyfslausn, litlaus eða aðeins gulleit, og laus við agnir.
English: Do not rub the injection site.
Icelandic: Ekki nudda stungustaðinn.
English: Kyntheum is administered by subcutaneous injection.
Icelandic: Kyntheum er gefið með inndælingu undir húð.
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Icelandic: Ef blæðir frá stungustaðnum skal þrýsta á hann með bómullarhnoðra eða grisju.
English: N = number of patients, which are presented at baseline, Week 12, and Week 52 Q2W = every 2 weeks *Patients were administered ustekinumab in the induction phase and continued on ustekinumab in the maintenance phase **Patients were administered Kyntheum 210 mg every 2 weeks in the induction phase and re-randomised to Kyntheum 210 mg every 2 weeks in the maintenance phase NRI= Non-responder imputation
Icelandic: **Sjúklingar fengu Kyntheum 210 mg á tveggja vikna fresti í innleiðslufasanum og var slembiraðað á ný til að fá Kyntheum 210 mg á tveggja vikna fresti í viðhaldsfasanum.
English: Diarrhoea Nausea
Icelandic: • þreytutilfinning
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Icelandic: Skrá ætti skýrt og greinilega heiti og lotunúmer lyfsins sem gefið er í því skyni að bæta rekjanleika líffræðilegra lyfja.
English: Borola Ltd
Icelandic: L04AC12
English: • diarrhoea
Icelandic: • niðurgangur
English: Contents of the pack and other information What Kyntheum contains
Icelandic: Hvernig geyma á Kyntheum Pakkningar og aðrar upplýsingar
English: • Kyntheum is injected in your upper legs (thighs) or stomach area (abdomen) by you or a caregiver.
Icelandic: Þú eða umönnunaraðili þinn dælir Kyntheum inn í efri hluta fótleggs (læri) eða á kviðsvæði
English: During the 12-week placebo-controlled clinical trial period in patients with psoriasis, a decrease in absolute neutrophil count (ANC) was observed in 5.6% of patients receiving Kyntheum, which was generally transient and reversible.
Icelandic: Lækkun á heildarfjölda daufkyrninga (ANC), sem yfirleitt var skammvinn og afturkræf, kom fram hjá 5,6% sjúklinga sem fengu
English: Kyntheum should be prescribed to you by a doctor with experience in diagnosing and treating psoriasis.
Icelandic: Læknir með reynslu af greiningu og meðhöndlun psóríasis ætti að ávísa Kyntheum.
English: It may harm them,
Icelandic: Notaður sprautuhólkur
English: Tinea infections (including tinea pedis, tinea versicolor, tinea cruris)
Icelandic: Sveppasýkingar (þ.m.t. fótsveppir, litbrigðasveppir, klofsveppir)
English: Solution for injection 2 pre-filled syringes
Icelandic: Stungulyf, lausn 2 áfylltar sprautur
English: Each
Icelandic: Meðganga
English: Patients enrolled were candidates for systemic therapy, including phototherapy, biologic and nonbiologic systemic therapies.
Icelandic: Sjúklingar sem þátt tóku í rannsóknunum voru metnir hæfir fyrir altæka meðferð, þ.m.t. ljósameðferð, altæka meðferð með líftæknilyfjum og altæka meðferð með lyfjum sem ekki eru líftæknilyf.
English: Upper arm Stomach area (abdomen)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Other populations
Icelandic: Aðrir sjúklingahópar
English: INSTRUCTIONS ON USE
Icelandic: Notkunarleiðbeiningar:
English: EU/1/12/791/001 Glybera
Icelandic: EU/1/12/791/001
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg bodyweight l t o r
Icelandic: Hver pakkning fyrir hvern sjúkling inniheldur nægilegt magn hettuglasa til þess að skammta hverjum sjúklingi 1 x 1012 gc/kg líkamsþyngdar i
English: 3 x 10¹² gc/ml Solution for injection
Icelandic: Glybera 3 x 10¹² gc/ml Stungulyf, lausn
English: Immediate Packaging
Icelandic: Innri umbúðir Innihald Pakkningastærð
English: MA (EU) number (Invented) name
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti Styrkleiki
English: Intramuscular use vial (glass)
Icelandic: Til notkunar í vöðva hettuglas (gler) 1 ml
English: Oral use sachet (PET/OPA/alu/LDPE)
Icelandic: Skammtapoki (PET/OPA/ál/LDPE)
English: 30 sachets + 1 mixing bottle + 30 single-use oral syringes + 1 screw cap with syringe-port capability
Icelandic: 30 skammtapokar + 1 blöndunarglas + 30 einnota munngjafarsprautur + 1 skrúftappi með opi fyrir sprautuenda
English: Pack size
Icelandic: Til inntöku
English: Powder for oral suspension
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: *** International units.
Icelandic: *** Alþjóðlegar einingar.
English: ** Antibody micro agglutination-lytic reaction.
Icelandic: ** Mótefnaörkekkjunarpróf (antibody micro agglutination-lytic reaction).
English: Rabies virus, strain SAD Vnukovo-32
Icelandic: Hundaæðiveira, stofn SAD Vnukovo-32
English: l Suspension (inactivated)
Icelandic: Dreifa (óvirkjuð)
English: * Tissue culture infectious dose 50%.
Icelandic: ≥ 2,0 a.e.*** * Skammtur sem dugar til að sýkja 50% smitaðra vefjarækta (tissue culture infectious dose 50%).
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Icelandic: Frostþurrkað stungulyf (lifandi veiklað) Hundaparainflúensuveira tegund 2, stofn CPiV-2-Bio 15
English: Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091
Icelandic: Leptospira kirschneri sermishópur Grippotyphosa sermisgerð Grippotyphosa, stofn MSLB 1091
English: Pharmaceutic al form
Icelandic: Lyfjaform Dýrategund
English: Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088
Icelandic: Leptospira interrogans sermishópur Australis sermisgerð Bratislava, stofn MSLB 1088
English: Route of administrati on
Icelandic: Íkomuleið Umbúðir
English: Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090
Icelandic: Leptospira interrogans sermishópur Canicola sermisgerð Canicola, stofn MSLB 1090
English: Packagin g
Icelandic: Pakkningastærð
English: Strengt h
Icelandic: Sérheiti Styrkleiki
English: Withdraw al period
Icelandic: Biðtími
English: Content Package size
Icelandic: ESB markaðsleyfisnúmer
English: EU/1/11/671/001
Icelandic: EU/1/11/671/001 Xiapex
English: Intralesional use powder: vial (glass) solvent: vial (glass)
Icelandic: Til notkunar í vefjaskemmd stungulyfsstofn: hettuglas (gler) leysir: hettuglas (gler)
English: 0.9 mg Powder and solvent for solution for injection
Icelandic: 0,9 mg stungulyfsstofn og leysir, lausn
English: Xiapex
Icelandic: Sérheiti
English: powder: 3 ml solvent: 5 ml
Icelandic: 3 ml leysir:
English: 1 vial + 1 vial
Icelandic: 1 hettuglas 1 hettuglas
English: Strength Pharmaceutical Form
Icelandic: Lyfjaform Íkomuleið Umbúðir
English: Packaging
Icelandic: Styrkur
English: Package size
Icelandic: Pakkningastæ rð
English: 10 vials (multidose: 10 doses)
Icelandic: 10 hettuglös (fjölskammta: 10 skammtar)
English: Strength Pharmaceutical Form
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: Content (concentration) Pack size
Icelandic: Innihald (þéttni)
English: Route of administration
Icelandic: Styrkleiki
English: A-1150 Vienna
Icelandic: A-1150 Vienna Austria
English: Berkshire SL6 0PH United Kingdom
Icelandic: Berkshire SL6 0PH
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Icelandic: Listi Yfir Heiti, Lyfjaform,Styrkleika Lyfjanna, Íkomuleið,, Markaðsleyfishafa Í Aðildarlöndunum
English: Arquiparque - Miraflores 1495-131 ALGÉS Portugal
Icelandic: - Miraflores 1495-131
English: TAZOCIN® EF
Icelandic: TAZOCIN®
English: Tietokuja 4, 00330 Helsinki, Finland
Icelandic: Tietokuja 4, 00330
English: Via Nettunense, 90 Aprilia (LT), 04011, Italy
Icelandic: Wyeth Lederle S.p.A. Via Nettunense, 90 Aprilia (LT), 04011, Italy
English: Wyeth Whitehall Export GmbH Storchengasse 1
Icelandic: Wyeth Whitehall Export GmbH
English: Coeur DéfenseTour A - La Défense 4 92931 PARIS LA DEFENSE Cedex
Icelandic: - La Défense 4 92931 PARIS LA DEFENSE Cedex,
English: Intravenous (Infusion, Injection)
Icelandic: Í bláæð (Innrennsli, inndæling)
English: Tazobactam .sodium 0,5366 g
Icelandic: Tazóbaktam natríum 0,5366 g
English: Piperacillin 4g and tazobactam
Icelandic: Píperasillín 4g og tazóbaktam
English: 28700 San Sebastián de los Reyes (Madrid)
Icelandic: Burgos, Km 23Desvío Algete Km 1 28700 San Sebastián de los Reyes (Madrid), Spain
English: Floridsdorfer Hauptstraße 1, A-1210 Wien
Icelandic: Floridsdorfer Hauptstraße
English: Tazobactam.sodium 0,2683 g
Icelandic: Tazóbaktam natríum 0,2683 g
English: Bulgaria
Icelandic: Búlgaria
English: 4 g piperacillin equivalent to 4.17 g piperacillin sodium
Icelandic: 4 g píperasillín sem jafngildir 4,17 g píperasillín natríum
English: 500mg both present as sodium salts.
Icelandic: 500mg hvort tveggja til staðar sem natríumsölt.