natgillin/translations-raw huggingface dataset:
Pregabalin Zentiva is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. 
Zdravilo Pregabalin Zentiva se uporablja za zdravljenje določene oblike epilepsije (parcialnih napadov s sekundarno generalizacijo ali brez nje) pri odraslih.
Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. 
Zdravilo Pregabalin Zentiva je indicirano za zdravljenje periferne in centralne nevropatske bolečine pri odraslih.
For three times a day take Pregabalin Zentiva once in the morning, once in the afternoon and once in the evening, at about the same time each day. 
Če jemljete zdravilo Pregabalin Zentiva trikrat na dan, ga vzemite zjutraj, popoldne in zvečer, in sicer vsak dan ob približno istem času.
Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. 
Zdravilo Pregabalin Zentiva je indicirano kot dodatno zdravljenje pri odraslih s parcialnimi napadi, s sekundarno generalizacijo ali brez nje.
The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p = 0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p = 0.2600 versus placebo) and 22.6% of those receiving placebo. 
Delež preskušancev z vsaj 50 % zmanjšanjem pogostnosti parcialnih napadov v primerjavi z izhodiščem je bil pri preskušancih, ki so prejemali pregabalin v odmerku 10 mg/kg/dan, 40,6 % (p = 0,0068 v primerjavi s placebom), pri preskušancih, ki so prejemali pregabalin v odmerku 2,5 mg/kg/dan, 29,1 % (p = 0,2600 v primerjavi s placebom) in pri tistih, ki so prejemali placebo, 22,6 %.
Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. 
Zdravljenje s pregabalinom je bilo povezano z omotico in somnolenco, ki lahko v starejši populaciji zveča pogostnost nezgodnih poškodb (padcev).
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. 
Raziskave in vivo in analiza populacijske farmakokinetike Skladno s tem v raziskavah in vivo niso ugotovili klinično pomembnih farmakokinetičnih interakcij med pregabalinom in fenitoinom, karbamazepinom, valprojsko kislino, lamotriginom, gabapentinom, lorazepamom, oksikodonom ali etanolom.
What Pregabalin Zentiva looks like and contents of the pack 
Izgled zdravila Pregabalin Zentiva in vsebina pakiranja
Your doctor will tell you to take Pregabalin Zentiva either twice or three times a day. 
Zdravilo Pregabalin Zentiva morate vzeti dvakrat ali trikrat na dan.
Pregabalin Zentiva may be taken with oral contraceptives. 
Zdravilo Pregabalin Zentiva lahko jemljete s peroralnimi kontraceptivi.
Dizziness, somnolence, loss of consciousness, confusion, and mental impairment 
Omotica, somnolenca, izguba zavesti, zmedenost in poslabšanje mentalnih sposobnosti
Pregabalin Zentiva is for oral use only. 
Zdravilo Pregabalin Zentiva je samo za peroralno uporabo.
How to store Pregabalin Zentiva Contents of the pack and other information 
Shranjevanje zdravila Pregabalin Zentiva Vsebina pakiranja in dodatne informacije
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased. 
Zdravljenje centralne nevropatske bolečine kot posledice poškodbe hrbtenjače Pri zdravljenju centralne nevropatske bolečine kot posledice poškodbe hrbtenjače je bila zvečana incidenca neželenih učinkov na splošno, neželenih učinkov, povezanih z osrednjim živčnim sistemom, in še posebno somnolence.
Capsules content Lactose monohydrate, Pregelatinized maize starch, Talc. 
Vsebina kapsule laktoza monohidrat predgelirani koruzni škrob smukec
Pregabalin Zentiva is used to treat generalised anxiety disorder (GAD). 
Zdravilo Pregabalin Zentiva se uporablja za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder).
Pregabalin Zentiva contains lactose monohydrate. 
Zdravilo Pregabalin Zentiva vsebuje laktozo monohidrat.
How to take Pregabalin Zentiva 
Kako jemati zdravilo Pregabalin Zentiva
Pregabalin Zentiva belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults. 
Zdravilo Pregabalin Zentiva sodi med zdravila, ki se uporabljajo za zdravljenje epilepsije, nevropatske bolečine in generalizirane anksiozne motnje pri odraslih.
In the 12-week placebo controlled study, paediatric patients (4 to 16 years of age) were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo. 
V 12-tedenski s placebom nadzorovani študiji so pediatrične bolnike (stare od 4 do 16 let) razvrstili v skupine, ki so prejemale pregabalin 2,5 mg/kg/dan (največ 150 mg/dan), pregabalin 10 mg/kg/dan
Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults. 
Zdravilo Pregabalin Zentiva je indicirano za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder) pri odraslih.
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score. 
V nadzorovanih kliničnih preskušanjih periferne nevropatske bolečine je 35 % bolnikov, ki so prejemali pregabalin, in 18 % bolnikov, ki so prejemali placebo, izkusilo 50-odstotno izboljšanje v točkovanju bolečine.
Pregabalin Zentiva 25 mg hard capsules Pregabalin Zentiva 50 mg hard capsules Pregabalin Zentiva 75 mg hard capsules Pregabalin Zentiva 100 mg hard capsules Pregabalin Zentiva 150 mg hard capsules Pregabalin Zentiva 200 mg hard capsules Pregabalin Zentiva 225 mg hard capsules Pregabalin Zentiva 300 mg hard capsules Pregabalin 
Pregabalin Zentiva 25 mg trde kapsule Pregabalin Zentiva 50 mg trde kapsule Pregabalin Zentiva 75 mg trde kapsule Pregabalin Zentiva 100 mg trde kapsule Pregabalin Zentiva 150 mg trde kapsule Pregabalin Zentiva 200 mg trde kapsule Pregabalin Zentiva 225 mg trde kapsule Pregabalin Zentiva 300 mg trde kapsule pregabalin
Do not stop taking Pregabalin Zentiva unless your doctor tells you to. 
Če ste prenehali jemati zdravilo Pregabalin Zentiva Ne prenehajte jemati zdravila Pregabalin Zentiva, razen če vam to naroči zdravnik.
Talk to your doctor or pharmacist before taking Pregabalin Zentiva. 
Pred začetkom jemanja zdravila Pregabalin Zentiva se posvetujte z zdravnikom ali farmacevtom.
Pregabalin Zentiva 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules. 
Pregabalin Zentiva 100 mg, 200 mg sta na voljo v pakiranjih po 21, 84, 98 in 100 trdih kapsul.
PAPER FOLDING BOX 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
Pregabalin Zentiva 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules. 
Pregabalin Zentiva 75 mg, 150 mg, 225 mg in 300 mg so na voljo v pakiranjih po 14, 56, 98 in 100 trdih kapsul.
Pregabalin Zentiva 50 mg hard capsules Capsule cap and body Black iron oxide (E172) Titanium dioxide (E171) Gelatin 
Pregabalin Zentiva 25 mg trde kapsule Pokrovček in telo kapsule - črni železov oksid (E172) - titanov dioksid (E171) - želatina
Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging. 
Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg in 300 mg trde kapsule so pakirane v PVC/alu pretisnih omotih kot primarni ovojnini.
Pregabalin Zentiva 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules. 
Pregabalin Zentiva 25 mg in 50 mg so na voljo v pakiranju po 14, 21, 56, 84, 98 ali 100 trdih kapsul.
Pregabalin Zentiva 225 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 225 mg
It is advised not to drink alcohol while taking Pregabalin Zentiva. 
Če jemljete zdravilo Pregabalin Zentiva, odsvetujemo pitje alkohola.
How to store Pregabalin Zentiva 
Shranjevanje zdravila Pregabalin Zentiva
Pregabalin Zentiva 150 mg hard capsules: EU/1/15/1021/017 
Pregabalin Zentiva 150 mg trde kapsule: EU/1/15/1021/017
What Pregabalin Zentiva contains 
Kaj vsebuje zdravilo Pregabalin Zentiva
Pregabalin Zentiva 50 mg hard capsules: EU/1/15/1021/006 
Pregabalin Zentiva 50 mg trde kapsule: EU/1/15/1021/006
Pregabalin Zentiva 225 mg hard capsules: EU/1/15/1021/023 
Pregabalin Zentiva 225 mg trde kapsule: EU/1/15/1021/023
Pregabalin Zentiva 150 mg hard capsules 
Pregabalin Zentiva 150 mg trde kapsule
Pregabalin Zentiva 75 mg hard capsules: EU/1/15/1021/011 
Pregabalin Zentiva 75 mg trde kapsule: EU/1/15/1021/011
Pregabalin Zentiva 300 mg hard capsules: EU/1/15/1021/026 
Pregabalin Zentiva 300 mg trde kapsule: EU/1/15/1021/026
Pregabalin Zentiva 200 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 200 mg
Pregabalin Zentiva 225 mg hard capsules 
Pregabalin Zentiva 225 mg trde kapsule
Pregabalin Zentiva 300 mg hard capsules 
Pregabalin Zentiva 300 mg trde kapsule
Pregabalin Zentiva 300 mg hard capsules Capsule cap 
Pregabalin Zentiva 300 mg trde kapsule Pokrovček kapsule
Pregabalin Zentiva 50 mg hard capsules 
Pregabalin Zentiva 50 mg trde kapsule
Pregabalin Zentiva 225 mg hard capsules Pregabalin 
Pregabalin Zentiva 225 mg trde kapsule pregabalin
Pregabalin Zentiva 225 mg hard capsules Capsule cap 
Pregabalin Zentiva 225 mg trde kapsule Pokrovček kapsule
Pregabalin Zentiva 75 mg hard capsules Pregabalin 
Pregabalin Zentiva 75 mg trde kapsule pregabalin
Pregabalin Zentiva 75 mg hard capsules Capsule cap 
Pregabalin Zentiva 75 mg trde kapsule Pokrovček kapsule
Zentiva logo 
ŠTEVILKA SERIJE Lot
Pregabalin Zentiva 100 mg hard capsules: EU/1/15/1021/014 
Pregabalin Zentiva 100 mg trde kapsule: EU/1/15/1021/014
Pregabalin Zentiva 25 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 25 mg
Pregabalin Zentiva 200 mg hard capsules: EU/1/15/1021/020 
Pregabalin Zentiva 200 mg trde kapsule: EU/1/15/1021/020
Pregabalin Zentiva 75 mg hard capsules 
Pregabalin Zentiva 75 mg trde kapsule
Pregabalin Zentiva 25 mg hard capsules: EU/1/15/1021/001 
Pregabalin Zentiva 25 mg trde kapsule: EU/1/15/1021/001
Pregabalin Zentiva 200 mg hard capsules 
Pregabalin Zentiva 200 mg trde kapsule
Pregabalin Zentiva 100 mg hard capsules Pregabalin 
Pregabalin Zentiva 100 mg trde kapsule pregabalin
Pregabalin Zentiva 150 mg hard capsules Pregabalin 
Pregabalin Zentiva 150 mg trde kapsule pregabalin
Pregabalin Zentiva 75 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 75 mg
Pregabalin Zentiva 25 mg hard capsules Pregabalin 
Pregabalin Zentiva 25 mg trde kapsule pregabalin
Pregabalin Zentiva 300 mg hard capsules Pregabalin 
Pregabalin Zentiva 300 mg trde kapsule pregabalin
Pregabalin Zentiva 100 mg hard capsules 
Pregabalin Zentiva 100 mg trde kapsule
Pregabalin Zentiva 100 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 100 mg
Pregabalin Zentiva 50 mg hard capsules Pregabalin 
Pregabalin Zentiva 50 mg trde kapsule pregabalin
Pregabalin Zentiva 25 mg hard capsules 
Pregabalin Zentiva 25 mg trde kapsule
Pregabalin Zentiva 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 200 mg pregabalina.
Pregabalin Zentiva 200 mg hard capsules Pregabalin 
Pregabalin Zentiva 200 mg trde kapsule pregabalin
Pregabalin Zentiva 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 100 mg pregabalina.
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin 
− rdeči železov oksid (E172)
Pregabalin Zentiva 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 150 mg pregabalina.
Pregabalin Zentiva 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 300 mg pregabalina.
Pregabalin Zentiva 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 75 mg pregabalina.
Pregabalin Zentiva 300 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 300 mg
Pregabalin Zentiva 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 50 mg pregabalina.
Pregabalin Zentiva 150 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 150 mg
BID or TID BID or TID Once daily or BID Once daily 
2- ali 3-krat/dan 2- ali 3-krat/dan 1-krat/dan ali 2krat/dan 1-krat/dan dodaten odmerek po hemodializi (mg)
Pregabalin Zentiva 25 mg hard capsules Capsule cap and body 
Pregabalin Zentiva 50 mg trde kapsule Pokrovček in telo kapsule
Pregabalin Zentiva 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 225 mg pregabalina.
Pregabalin Zentiva 50 mg 
PODATKI V BRAILLOVI PISAVI Pregabalin Zentiva 50 mg
The physician information should contain the following key messages: 
Podatki za zdravnika morajo vsebovati naslednje ključne vsebine:
• The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data; 
• o možnosti vključevanja bolnikov v študijski register, s katerim bi omogočili zbiranje dolgoročnih podatkov o učinkovitosti in varnosti zdravila;
• The proper patient management as regards the interaction with vaccination; 
• o ustreznem vodenju bolnikov glede interakcij s cepivi;
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris; 
• o tveganju za resne okužbe, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami, pri bolnikih, ki prejemajo zdravilo Ilaris;
• The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms; 
• o ugotovljenih ali možnih tveganjih za imunogenost, ki bi lahko povzročila imunsko povzročene simptome;
• The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors; 
• o potrebi za poučevanje bolnikov glede ustreznih tehnik samoinjiciranja v primeru, da je bolnik pripravljen in sposoben samoinjiciranja, ter navodila za zdravstvene delavce glede poročanja napak pri apliciranju zdravila;
• The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies; 
• o potrebi za vsakoletno klinično presojo bolnikov, ki jo morajo izvajati zdravstveni delavci glede možnega povečanja tveganja za razvoj malignih bolezni;
• The role and use of patient alert card. 
• o namenu in uporabi opozorilne kartice za bolnika.
• The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Ilaris as treatment with Ilaris should not be initiated in patients with neutropenia; 
• o potrebi za določanje števila nevtrofilcev pred začetkom zdravljenja, 1 do 2 meseca po začetku zdravljenja in nato v rednih presledkih med zdravljenjem z zdravilom Ilaris, saj se pri bolnikih z nevtropenijo ne sme uvesti zdravljenja z zdravilom Ilaris;
• The need to monitor patients for changes in their lipid profiles; 
• o potrebi za spremljanje bolnikov glede sprememb vrednosti lipidov v krvi;
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Država članica mora zagotoviti vzpostavitev vseh pogojev ali omejitev v zvezi z varno in učinkovito uporabo zdravila, kot je opisano spodaj.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VZPOSTAVITI DRŽAVE ČLANICE
• Physician information 
• podatke za zdravnika,
• The risk of acute injection-related reactions; 
• o tveganju za akutne reakcije, do katerih lahko pride zaradi injiciranja;
• The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant; 
• o dejstvu, da varnost uporabe zdravila Ilaris med nosečnostjo in dojenjem ni opredeljena in mora zato zdravnik bolnicam razložiti tveganje v primeru, da zanosijo ali načrtujejo nosečnost;
Therefore, it should not be used in these indications outside the context of a clinical trial. 
Zato se ga ne sme uporabljati za takšne indikacije izven okvira kliničnih preskušanj.
• Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients. 
• Obveznosti zdravnikov v zvezi s predpisovanjem romiplostima in potreba po zagotavljanju izčrpnega svetovanja bolnikom o koristi in tveganju.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO BITI ZAGOTOVLJENI S STRANI DRŽAVE ČLANICE
Antibody testing available upon request of physician, contact details for this antibody testing. 
Testiranje protiteles, ki je na razpolago na zdravnikovo zahtevo, in kontaktne podrobnosti za to testiranje protiteles.
The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented: 
Država članica mora zagotoviti vse spodaj navedene pogoje v zvezi z varno in učinkovito uporabo zdravil:
• The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment. 
• Ti dokumenti bodo obravnavali naslednja ugotovljena in možna tveganja: Incidenco v kliničnih preskušanjih in verjetnost za ponovitev trombocitopenije po prenehanju zdravljenja.
Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration. 
Priskrbljeno bo računalo odmerka za enostavnejše izračunavanje pravilnega odmerka ter navodilo za pravilno pripravo in apliciranje.
Advice on when further investigations and a bone marrow biopsy might be appropriate. 
Nasvet, kdaj so primerne nadaljnje preiskave in biopsija kostnega mozga.
Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML. 
Podatki iz kliničnih preskušanj pri MDS o incidenci porasta blastnih celic in napredovanju v AML.
Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis. 
Romiplostima se ne sme uporabljati pri bolnikih z zmerno ali hudo okvaro jeter, razen če pričakovana korist odtehta ugotovljeno tveganje za portalno vensko trombozo.
Advice on management of patients upon cessation of romiplostim. 
Nasvet o medicinski oskrbi bolnikov po prenehanju uporabe romiplostima.
Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range. 
Nasvet o upoštevanju smernic za prilagoditev odmerka, da bi se izognili številu trombocitov, večjemu od normalnega.
If use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications. 
Če je uporaba romiplostima potrebna, je treba število trombocitov natančno kontrolirati, da bi zmanjšali tveganje za trombembolične zaplete.
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: 
Takšen program mora izvesti na nacionalni ravni, da bodo pred predpisovanjem zdravila vsi zdravniki dobili informacijski komplet za zdravstveno osebje, ki vsebuje:
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling 
• Povzetek glavnih značilnosti zdravila (SmPC) in navodilo za uporabo
The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome). 
Možnost trombemboličnih dogodkov pri bolnikih s kronično ITP and pri tistih z znanimi dejavniki tveganja za trombembolične dogodke (npr. faktorjem V Leiden, pomanjkanjem ATIII, antifosfolipidnim sindromom).
Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim. 
Osnovne deleže retikulina v kostnem mozgu pri bolnikih z ITP ter ugotovljeno incidenco in možne mehanizme odlaganja retikulina kot odziv na romiplostim.
Background information on reticulin in the bone marrow. 
Osnovne informacije o retikulinu v kostnem mozgu.
Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS). 
Romiplostim lahko izzove napredovanje obstoječih hematoloških malignomov in mielodisplastičnega sindroma.
Clarification that risk-benefit for the treatment of paediatric ITP has not been established. 
Pojasnilo, da koristi in tveganja zdravljenja pediatrične ITP niso ugotovljeni.
The incidence of medication errors in clinical trials. 
Incidenco napak z zdravilom v kliničnih preskušanjih.
Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis. 
Opozorilo, da je možna (ker ni na voljo podatkov) posledica odlaganja retikulina kot odziv na romiplostim fibroza kostnega mozga.
The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO). 
Posledice navzkrižnega reagiranja protiteles, ki nevtralizirajo romiplostim, z endogenim trombopoetinom (TPO).
The incidence of neutralising antibodies to romiplostim in clinical trials. 
Incidenco pojava nevtralizirajočih protiteles proti romiplostimu v kliničnih preskušanjih.
Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established. 
Ponoven poudarek, da koristi in tveganja zdravljenja trombocitopenije niso ugotovljene pri bolnikih brez ITP.
• Posology 
• Odmerjanje
The incidence in clinical trials of thrombotic/thromboembolic complications. 
Incidenco trombotičnih/trombemboličnih zapletov v kliničnih preskušanjih.
United Kingdom Alkem Pharma GmbH 
Velika Britanija Alkem Pharma GmbH
Invented name 
Predlagatelj Izmišljeno ime Zdravilna učinkovina
Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet 
Ricefan 500 mg Cefuroksim 500 mg Filmsko obložena tableta
Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet 
Ricefan 250 mg Cefuroksim 250 mg Filmsko obložena tableta
14 October 2016 EMA/659373/2016 EMEA/H/C/004306 
14. oktober 2016 EMA/659373/2016 EMEA/H/C/004306
active form happens more readily in cancer cells than in normal cells. 
Pretvorba v aktivno obliko lažje poteka v rakavih celicah kot v normalnih celicah.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je za umik vloge odločila zaradi spremembe poslovne strategije.
The company had not yet responded to the questions at the time of the withdrawal. 
Družba ob umiku še ni odgovorila na zastavljena vprašanja.