natgillin/translations-raw huggingface dataset:
Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p <0.001) and adalimumab monotherapy (p <0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
• kidney problems;
• težave z ledvicami;
ACR 50 52 Week
52. tedna dosegli odziv ACR 50.
There is no relevant use of adalimumab in children aged below 6 years for this indication.
Uporaba adalimumaba pri otrocih, starih manj kot 6 let, za to indikacijo ni primerna.
Citric acid monohydrate Histidine
Pomožne snovi: natrijev citrat, citronska kislina monohidrat, histidin, histidinijev klorid monohidrat,
Adalimumab Δ Censored Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Opomba: P = placebo (število rizičnih preiskovancev (zagon bolezni)); A = adalimumab (število rizičnih preiskovancev (zagon bolezni)).
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 %
If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40-mg injections in 1 day) followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
Uncommon Rhabdomyolysis, systemic lupus erythematosus
sistemski eritematozni lupus redki sindrom, podoben lupusu
Very common Lipids increased Common
Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokaliemija,
In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
Imraldi 40 mg solution for injection in pre-filled syringe EU/1/17/1216/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/17/1216/009
Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
ki tehtajo 30 kg ali več, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
• When the syringe is empty, remove the needle from skin, being careful to pull it out at the same angle as when it was inserted.
• Ko je brizga prazna, iglo potegnite iz kože.
If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later.
Običajni začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
81 nadaljevalo zdravljenje s 40 mg adalimumaba vsak drugi teden še 10 let.
Stratum
RTa
* p <0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p <0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Bolniki v remisiji brez steroidov ≥ 90 dnia * p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide
Check with your doctor before your child receives any vaccines.
Preden vaš otrok opravi kakršnokoli cepljenje, se posvetujte z zdravnikom.
It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Pomembno je, da zdravniku poveste, če vaš otrok doživi simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
**p <0.01, adalimumab versus placebo - Not applicable
c MTX = metotreksat **p < 0,01, adalimumab v primerjavi s placebom - Ne pride v poštev
Skin Painb
ali stegna.
• adolescent hidradenitis suppurativa,
• hidradenitis suppurativa pri mladostnikih,
It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Pomembno je, da zdravniku poveste, če ima vaš otrok simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIAL PACK)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (PAKIRANJE Z VIALO)
CD study I: Infliximab Naive Patients
Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN
and were originally randomised to active therapy in Period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg adalimumaba vsak drugi teden ali placebo.
Keep the syringe in the outer carton in order to protect from light.
Brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.
4 leta do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
Week 16 Placebo-Controlled
Kontrolirana s placebom
If these medicines do not work well enough, patients will be given Imraldi to reduce the signs and symptoms of your disease.
Če ta zdravila ne bodo delovala dovolj dobro, bodo bolniki za zmanjšanje znakov in simptomov bolezni dobili zdravilo Imraldi.
In monotherapy, some patients who experience a decrease in their response to Imraldi 40 mg every other week dosing may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv na zdravilo zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
Talk to your child's doctor or pharmacist before using Imraldi.
Pred začetkom uporabe zdravila Imraldi se posvetujte z zdravnikom vašega otroka ali farmacevtom.
Inhibition of inflammation
Shranjevanje injekcijske brizge
Autoantibodies Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies
V študijah revmatoidnega artritisa I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
solution for injection 1 pre-filled syringe 2 alcohol pads
raztopina za injiciranje 1 napolnjena injekcijska brizga
Your child's doctor should test your child for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Zdravnik mora vašega otroka testirati na HBV.
The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Običajni začetni odmerek za odrasle z luskavico (psoriazo) je 80 mg (kot dve 40 mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
• ear infections;
• okužbe ušesa;
If this dose does not work well enough, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik vašega otroka odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is an initial dose of 20 mg, followed by 20 mg one week later.
Otroci in mladostniki, starejši od 6 let, ki tehtajo od 15 kg do manj kot 30 kg Priporočeni odmerek zdravila Imraldi je 20 mg vsak drugi teden.
There is no relevant use of adalimumab in children aged less than 2 years in this indication.
Uporaba adalimumaba pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
DO NOT touch the vial stopper after wiping with the alcohol pad.
Potem, ko ste zamašek viale obrisali z alkoholnim zložencem, se zamaška NE DOTIKAJTE.
Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih revmatoidnega artritisa so adalimumab ocenili pri več kot
RA study Ia**
Študija revmatoidnega artritisa Ia**
Rare
adalimumabb
If a faster response is required, your child's doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
This medicinal product contains 20 mg sorbitol in each pre-filled pen.
To zdravilo vsebuje 20 mg sorbitola v napolnjenem injekcijskem peresniku.
7.2 % of patients receiving placebo or active control.
1,3 % bolnikov v kontrolni skupini.
Biogen Inc.
Icepharma hf.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Primarna končna točka študije revmatoidnega artritisa V je bil odstotek bolnikov, ki so do
If this dose does not work well enough to Imraldi 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week .
Če odziv na zdravilo Imraldi 40 mg vsak drugi teden ne bo zadosten, bo zdravnik odmerek lahko povečal na 40 mg vsak teden ali na 80 mg vsak drugi teden.
μg/ml (95% CI: 1-6 μg/ml).
ICAM-1 z IK50 0,1-0,2 nM).
• 40 mg at week 0 and 20 mg at week 2
40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
EU/1/17/1216/008
EU/1/17/1216/007 EU/1/17/1216/008
Imraldi 40 mg solution for injection in pre-filled syringe
Imraldi 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
• If you dropped your syringe with the cap ON, it is okay to use the syringe.
• Če vam je injekcijska brizga padla, ko je bil pokrovček še NAMEŠČEN, jo smete uporabiti.
Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is 20 mg every other week.
Otroci, mladostniki in odrasli s poliartikularnim juvenilnim idiopatskim artritisom Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg Priporočeni odmerek zdravila Imraldi je 20 mg vsak drugi teden.
• psoriasis,
oniholiza,
14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
> 32 tednov 20 tednov > 32 tednov 14 tednov a Odzivi »Paed ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo.
Confirm completion & dispose
Prepričajte se, da je injiciranje zaključeno, in zavrzite
Each 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
• Keep your syringe in its carton, and away from light.
• Injekcijsko brizgo shranite v njeni kartonski škatli in zaščiteno pred svetlobo.
It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Pomembno je, da zdravniku poveste, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
EU/1/17/1216/006
EU/1/17/1216/005 EU/1/17/1216/006
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Pomembno je, da poveste zdravniku, če dobite znake okužbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
brazgotinjenje redki multiformni eritem sindrom Stevens-Johnson angioedem kožni vaskulitis lihenoidna reakcija neznana poslabšanje simptomov dermatomiozitisa
• You might get infections more easily while you are receiving Imraldi treatment.
• Med zdravljenjem z zdravilom Imraldi se lahko poveča dovzetnost za okužbe.
If this dose does not work well enough, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
OTHER
Znova
Injection site care
Shranjevanje injekcijskega peresnika
No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
ki so bili med preskušanjem adalimumaba izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
Imraldi 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
En 0,8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba.
If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Uporaba adalimumaba pri bolnikih, starih manj kot 4 leta, za to indikacijo ni primerna.
Adverse Reaction alopecia1), pruritus
Zdravljenje placebo adalimumab Δ anonimizirano
• autoantibodies present in the blood;
• avtoprotitelesa prisotna v krvi; • nizke krvne vrednosti za kalij.
Solution for injection (injection).
raztopina za injiciranje (injekcija) bistra, brezbarvna raztopina
Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom,
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
• 40 mg v 0. tednu in 20 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
Uncommon Inflammation
Neželeni učinki pogostnost
In Psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15).
V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do
How to inject with your vial 1) Setting up
Kako injicirati z vialo
Continued therapy should be reconsidered in a patient not responding within this time period.
Pri bolniku, ki se v tem času ne odzove na zdravljenje, je treba ponovno razmisliti o nadaljevanju zdravljenja.
• numbness;
• omrtvelost;
Adalimumab 40 mg eow
Adalimumab 80/40 mg
GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia,
Žilne bolezni pogosti hipertenzija, zardevanje, hematom občasni aortna anevrizma,
Skin Pain b
≥ 30 % zmanjšanje bolečine na koži b
DO NOT set the syringe down at any time.
Brizge nikoli NE ODLOŽITE.
• low blood potasium.
• nizke krvne vrednosti za kalij.
Impaired healing
Zdravljenje prek
Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
• With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
• Medtem ko je adapter za vialo še v prozorni ovojnini, ga namestite na pokrovček viale.
• liver failure;
• izpadanje las;
Your single-dose pre-filled syringe
otekanje oči občasni diplopija
Very common Abdominal pain, nausea and vomiting
Bolezni prebavil zelo pogosti bolečine v trebuhu, navzea in bruhanje pogosti gastrointestinalna krvavitev, dispepsija,
The recommended Imraldi dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
160 mg na 1. dan (aplicirano v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (aplicirano v obliki dveh 40 mg injiciranj v enem dnevu).
Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
-56,2a a p <0,001, adalimumab v primerjavi s placebom Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi s placebom.
Combino Pharm Portugal, Unipessoal, Lda.
Portugalska Combino Pharm Portugal, Unipessoal, Lda.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Priloga I Seznam imen, farmacevtskih oblik, jakosti, poti uporabe zdravil in imetnikov dovoljenja za promet z zdravili v državah članicah
Mylan SAS 117, allée des Parcs 69800 Saint-Priest France
Francija Mylan SAS 117, allée des Parcs 69800 Saint-Priest France
Parenteral use
Parenteralna uporaba
GUERBET B.P.
Španija GUERBET B.P.
Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia Bulgaria
Bolgarija Pharmalog AG, 33 Cherni vrah blvd., 1421 Sofia
Lek farmacevtska družba d.d.,
Slovenija Lek farmacevtska družba d.d.,
49, avenue Georges Pompidou
Francija SANDOZ 49, avenue Georges Pompidou
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Poljska Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
Poljska VIFOR France SA 123 Rue Jules Guesde 92200 Neuilly-sur-Seine France
Lek Pharmaceuticals d.d.
Estonija Lek Pharmaceuticals d.d.
IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier
Francija IBD3 Pharma Consulting Immeuble l'Orient 10, place Charles Béraudier 69003 Lyon France
G.E.S.
Španija G.E.S.
Sweden Orion Corporation, Orionintie 1,
Švedska Orion Corporation, Orionintie 1,
Sanofi-Aventis Zrt Tó utca 1-5, 1045 Budapest Hungary
Madžarska Sanofi-Aventis Zrt Tó utca 1-5,
Oral use Intravenous use
Oralna uporaba Intravenska uporaba
Denmark Orion Corporation, Orionintie 1,
Danska Orion Corporation, Orionintie 1,
Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex
Nemčija Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany
Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande,
Portugalska Farmoz - Sociedade Técnico Medicinal, S.A.
Rua João de Deus, 19 2700-487 Amadora Portugal
2700-487 Amadora Portugal
Intramuscular use
Intramuskularna uporaba
Concentrate for suspension for infusion
Koncentrat za suspenzijo za infundiranje
Intravenous use intramuscular use
Intravenska uporaba intramuskularna uporaba
Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
Karboksimaltoza Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje
Pharmaki Generics Ltd 5 Bourlet Close W1W 7BL London United Kingdom
Francija Pharmaki Generics Ltd 5 Bourlet Close
92931 Paris La Défense Cedex
Francija TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex FRANCE
Iron(III) isomaltoside complex
Kompleks železovega (III) izomaltozida
Ferric carboxymaltose complex
Kompleks železove karboksimaltoze
FERINJECT 50 mg fer/ml
FERINJECT 50 mg fer/ml 50 mg/ml
FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
INJECTION/CONCENTRA TE FOR SOLUTION FOR INFUSION 20MG/ML
Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid
Španija Laboratorios Normon S.A. Ronda de Valdecarrizo 6
Ferric carboxymaltose
Železova karboksimaltoza
Germany Medice Arzneimittel Pütter GmbH & Co KG
Nemčija Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
69003 Lyon
28760 Tres Cantos
Concentrate for solution for injection
Koncentrat za raztopino za injiciranje
Solution for perfusion
Raztopina za perfundiranje
Iceland VIFOR France SA 7-13 Boulevard Paul Emile Victor
Islandija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Sodium ferric gluconate complex
Kompleks natrijevega železovega glukonata
Metamorfosi Attikis 14452 Greece
Athens 14564 Greece
Iron (III) hydroxide dextran complex
Kompleks železovega (III) hidroksid dekstrana
Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor
Romunija VIFOR France SA 7-13 Boulevard Paul Emile Victor
FRANCE
Madrid
Denmark Fresenius Medical Care Nephrologica Deutschland GmbH
Danska Fresenius Medical Care Nephrologica Deutschland GmbH
Sweden Fresenius Medical Care Nephrologica Deutschland GmbH
Švedska Fresenius Medical Care Nephrologica Deutschland GmbH
Sweden VIFOR France SA 7-13 Boulevard Paul Emile Victor
Švedska VIFOR France SA 7-13 Boulevard Paul Emile Victor
Germany Fresenius Medical Care Nephrologica Deutschland GmbH
Nemčija Fresenius Medical Care Nephrologica Deutschland GmbH
Germany VIFOR France SA 7-13 Boulevard Paul Emile Victor
Nemčija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Lithuania VIFOR France SA 7-13 Boulevard Paul Emile Victor
Slovenija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Denmark VIFOR France SA 7-13 Boulevard Paul Emile Victor
Danska VIFOR France SA 7-13 Boulevard Paul Emile Victor
Lithuania Fresenius Medical Care Nephrologica Deutschland GmbH
Slovenija Fresenius Medical Care Nephrologica Deutschland GmbH
Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor
Francija VIFOR France SA 7-13 Boulevard Paul Emile Victor
Finland Fresenius Medical Care Nephrologica Deutschland GmbH
Španija Fresenius Medical Care Nephrologica Deutschland GmbH
Solution for injection Solution for infusion
Raztopina za injiciranje
FERROLOGIC 20 MG/ML
FERROLOGIC 20 MG/ML 20 mg/ml