natgillin/translations-raw huggingface dataset:
Active substance: 150 mg of gamithromycin Excipients: 1 mg of monothioglycerol Colourless to pale yellow solution. 
1 ml raztopine vsebuje Aktivna učinkovina:150 mg gamitromicina Pomožne snovi: 1 mg monotioglicerola Brezbarvna do bledo rumena raztopina.
Macrolides inhibit bacterial protein biosynthesis by binding to the 50S ribosomal subunit and by preventing peptide chain elongation. 
Biosintezo bakterijskih proteinov zavirajo z vezavo na 50S ribosomne podenote in preprečijo podaljševanje polipeptidne verige.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (50ml/100ml/250 ml)
• Visible injection site swellings associated with occasional slight pain may develop very commonly in cattle for one day. 
- Vidne otekline na mestu dajanja, ki so povezane z občasno, blago bolečino, ki traja en dan se lahko zelo pogosto pojavijo pri govedu.
• Mild to moderate injection site swelling has been reported commonly in sheep and pigs in clinical trials, with occasional slight pain evident for one day in sheep. 
- Blaga do zmerna oteklina na mestu dajanja je bila pogosto opisana pri prašičih in ovcah med kliničnimi študijami, z včasih pridruženo blažjo bolečino pri ovcah v trajanju en dan.
If eye exposure occurs, flush eyes immediately with clean water. 
Če pride do stika zdravila z očmi, takoj sperite s čisto vodo.
Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients. 
Ne uporabite v primerih preobčutljivosti na makrolidne antibiotike ali pomožne snovi.
Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months (cows, heifers) or 1 month (ewes) of expected parturition. 
Ne uporabite pri brejih živali, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev (krave in telice) ali 1 meseca (ovce) pred pričakovanim porodom.
Do not use this veterinary medicinal product simultaneously with other macrolides or antibiotics known as lincosamides. 
Ne uporabite tega zdravila za uporabo v veterinarski medicini sočasno z drugimi makrolidnimi antibiotiki ali antibiotiki, ki jim pravimo linkozamidi .
Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. 
Zdravljenje in metafilaksa respiratorne bolezni govedi (BRD) povezane z okužbami z Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
SC (cattle, sheep), IM (pigs) 
s.c. (govedo, ovce), i.m.
The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae,Haemophilus parasuis and Bordetella bronchiseptica, the bacterial pathogens most commonly associated with BRD and SRD, and also Fusobacterium necrophorum and Dichelobacter nodosus. 
Širok spekter protimikrobnega delovanja gamitromicina vključuje Manheimia haemolytica, Pasteurella multocida,Histophilus somni, Actinobacillus pleuropneumoniae, Haemophilus parasuis in Bordetella bronchiseptica, bakterijske povzročitelje, ki so najpogosteje povezani z BRD in SRD,
The presence of the disease in the herd should be established before metaphylactic use. 
Pred metafilaktičnim zdravljenjem je potrebno potrditi prisotnost bolezni v čredi.
Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides. 
Izogibajte se istočasnemu dajanju antibiotikov s podobnim načinom delovanja, kot so na primer makrolidi in linkozamidi.
Gamithromycin administered subcutaneously into the neck of sheep at a single dose of 6 mg/kg body weight is rapidly absorbed, and maximum plasma concentrations were observed between 15 minutes and 6 hours after dosing (2.30 hours on average) with high absolute bioavailability of 89%. 
Po subkutani aplikaciji gamitromicina v vrat pri ovcah v enkratnem odmerku 6 mg/kg telesne teže, je učinkovine hitra, z viškom koncentracije v plazmi med 15 minut in 6 ur po dajanju (povprečje 2,30 ure) in z visoko absolutno biorazpoložljivostjo > 89%.
50 μg/kg 300 μg/kg 200 μg/kg 
50 μg/kg 50 μg/kg 300 μg/kg 200 μg/kg
Pharmacotherapeutic group: Antibacterials for systemic use, macrolides ATC vet code: QJ01FA95. 
Oznaka ATC vet: QJ01FA95.
Polypropylene vial of 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal. 
Polipropilenska viala s 100, 250 ali 500 ml, s klorobutilnim gumijastim zamaškom, polipropilensko zaporko in aluminijastim tesnilom.
Type 1 glass vial of 50, 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal. 
Steklena viala (steklo tip 1) s 50, 100, 250 ali 500 ml, s klorobutilnim gumijastim zamaškom, polipropilensko zaporko in aluminijastim tesnilom.
1 ml contains 150 mg of gamithromycin, 
1 ml raztopine vsebuje 150 mg gamitromicina,
Cattle, sheep and pigs. 
Govedo, ovce in prašiči.
Subcutaneous injection. 
Subkutano injiciranje.
Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida,Haemophilus parasuis and Bordetella bronchiseptica. 
Zdravljenje respiratorne bolezni prašičev (SRD), povezane z okužbami z Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in Bordetella bronchiseptica.
1 ml contains 150 mg of gamithromycin 
1 ml vsebuje 150 mg gamitromicina.
• Rare (more than 1 but less than 10 animals in 10,000 animals treated) 
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Not for use in animals producing milk for human consumption 
Ni dovoljena uporaba pri živalih v laktaciji, ki proizvajajo mleko za prehrano ljudi
Gamithromycin skin concentrations were much higher than the plasma concentrations resulting in skin/plasma concentration ratios of approximately 21, 58, and 138 at two, five and ten days post-dosing, respectively, demonstrating extensive distribution and accumulation in skin tissue. 
Koncentracije gamitromicina v koži so veliko večje kot koncentracije v krvni plazmi, z razmerjem koncentracij koža/plazma približno 21, 58
Cattle, sheep, pigs 
Govedo, ovce, prašiči
Shelf life after first opening the container: 28 days Once opened, use by __/__/__ 
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
SC (cattle) IM (pigs) Read the package leaflet before use. 
(prašiči) Pred uporabo preberite navodilo za uporabo.
In vitro plasma protein binding studies determined that the mean concentration of the free active drug was 77 %. 
In vitro študije vezave na proteine plazme kažejo, da je povprečna koncentracija proste učinkovine 77%, Najpomembnejša pot izločanja nespremenjenega zdravila je z biliarno ekskrecijo.
Do not use in pregnant cows and heifers which are intended to produce milk for human consumption, within 2 months of expected parturition. 
Ne uporabite pri brejih kravah in telicah, katerih mleko je namenjeno prehrani ljudi, v obdobju
Overdose: 
Inkompatibilnosti:
Pigs: intramuscular injection. 
Prašiči: Intramuskularno
Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life (> 2 days). 
Govedo Po subkutani aplikaciji gamitromicina v predel vratu pri govedu v enkratnem odmerku 6 mg/kg telesne teže, je absorbcija učinkovine izjemno hitra, z viškom koncentracije v plazmi po 30 do
Fat 
Maščoba
Cattle and pigs: None. 
Govedo in prašiči:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL 100 ml, 250 ml 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Viala 100 ml, 250 ml
ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin 
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo in prašiče Gamitromicin
Pigs Intramuscular injection. 
Prašiči: intramuskularno
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs 
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin 
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče Gamitromicin
PACKAGE LEAFLET: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs 
NAVODILO ZA UPORABO ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGE UNITS VIAL 50 ml 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL 500 ml 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Viala 500 ml
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
NEMČIJA Proizvajalec, odgovoren za sproščanje serije:
A. 
EU.
Gamithromycin administered intramuscularly in pigs at single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 5 to 15 min, with a long plasma half-life (about 4 days). 
je absorbcija učinkovine izjemno hitra, z viškom koncentracije v plazmi po 5 do 15 minutah in z dolgo biološko razpolovno dobo (približno 4 dni).
Bovine 20 μg/kg 200 μg/kg 
Gamitromicin Gamitromicin govedo 20 μg/kg 200 μg/kg
The scientific value of these papers is rather limited. 
Znanstvena vrednost teh dokumentov je precej omejena.
Benefit/Risk Assessment 
Ocena koristi/tveganja
The publications were grouped in three chapters according to the indications: 
Objave so bile glede na indikacije združene v tri poglavja:
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MYDERISON 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA MYDERISON
A similar range is recommended in the Product Information in most countries. 
Podoben razpon odmerka je priporočen v informacijah o zdravilu v večini držav.
This procedure concerns a bibliographic application of tolperisone film-coated tablets with Hungary as the Reference Member State in the Mutual Recognition Procedure (MRP). 
Ta postopek zadeva bibliografsko uporabo filmsko obloženih tablet tolperizona z Madžarsko kot referenčno državo članico v postopku z medsebojnim priznavanjem (MRP).
The highly variable PK needs to be carefully addressed since the potential efficacy and safety implications are high. 
Visoko variabilno farmakokinetiko je treba natančno preučiti, saj so morebitne posledice za učinkovitost in varnost velike.
However there was no significant difference in the mobility of patients treated with tolperisone or placebo. 
Vendar pa ni bilo bistvene razlike v mobilnosti bolnikov, zdravljenih s tolperizonom ali placebom.
The CHMP considered that the “Well-Established” use in accordance to Article 10(a) of Directive 2001/83/EC for Myderison has not been demonstrated. 
Odbor za zdravila za uporabo v humani medicini meni, da „dobro uveljavljena“ uporaba v skladu s členom 10(a) Direktive 2001/83/ES za zdravilo Myderison ni bila dokazana.
Furthermore, the oral dose might need to be individualised within the recommended dose range 150-450 mg / day according to the clinical needs. 
Poleg tega bi bilo morda treba individualizirati peroralni odmerek znotraj priporočenega odmerka 150-450 mg/dan v skladu s kliničnimi potrebami.
The Marketing Authorisation Holder, Meditop Pharmaceutical Co. Ltd., was applying for marketing authorisations for Myderison in Czech Republic, Germany, Lithuania, Poland, Romania and Slovakia. 
Imetnik dovoljenja za promet z zdravilom Meditop Pharmaceutical Co. Ltd. je podal vlogo za dovoljenje za promet z zdravilom Myderison v Češki republiki, Nemčiji, Litvi, na Poljskem, v Romuniji in na Slovaškem.
The third indication of Mydeton, rehabilitation after orthopaedic and traumatological surgery, is supported only by two observational studies. 
Tretja indikacija zdravila Mydeton, rehabilitacija po ortopedski in travmatološki operaciji, je podprta samo z dvema opazovalnima študijama.
It means that all drugs which metabolism depends on the activity of this system may potentially interact with tolperisone or vice versa. 
To pomeni, da lahko vsa zdravila, katerih presnavljanje je odvisno od dejavnosti tega sistema, medsebojno delujejo s tolperizonom in obratno.
A Potential Serious Risk for Public Health was raised by the Czech Republic, Lithuania and Slovakia. 
Češka republika, Litva in Slovaška so vložile ugovor zaradi možnega resnega tveganja za javno zdravje.
The originator medicinal product is Mydeton and it was developed by Gedeon Richter, Ltd. 
Originatorsko zdravilo je Mydeton, ki ga je razvilo podjetje Gedeon Richter, Ltd.
Out of the other publications six reported on the results of comparative, but open studies, and tolperisone was used added on to a very complex (medicinal and physical) combined therapy. 
Izmed drugih objav jih je šest poročalo o rezultatih primerjalnih, toda odprtih študij, tolperizon pa se je uporabljal kot dodatek k zelo kompleksni (z zdravili in fizični) kombinirani terapiji.
The majority of clinical studies with tolperisone have been performed in a dose range of 150-450 mg/day. 
Večina kliničnih študij s tolperizonom je bila izvedena z razponom odmerka 150-450 mg/dan.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REFUSAL 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAVRNITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
No data of epidemiological studies on the safety of tolperisone in clinical use have been provided. 
Predloženi niso bili nobeni podatki o epidemioloških študijah o varnosti tolperizona v klinični uporabi.
From these 15 publications only one (Pratzel et al 1996) was published in an international peer reviewed journal that had acceptable standard and scientific value (double blind, randomised, placebo controlled). 
Izmed teh 15 objav je bila samo ena (Pratzel in dr. 1996) objavljena v strokovno medsebojno pregledani reviji, ki je imela sprejemljiv standard in znanstveno vrednost (dvojno slepa, randomizirana, nadzorovana s placebom).
The other papers only refer to observational studies, congress-reports or reviews (published in Hungarian) having limited scientific value. 
Drugi dokumenti se sklicujejo na opazovalne študije, poročila s kongresov ali preglede (objavljene v madžarščini), ki imajo omejeno znanstveno vrednost.
GROUNDS FOR REFUSAL 
PODLAGA ZA ZAVRNITEV DOVOLJENJA ZA PROMET
The MAH presented a new study report, MDTP-T20091B, which was a PK study sponsored by Meditop performed in 48 healthy volunteers. 
Imetnik dovoljenja za promet z zdravilom je predložil novo poročilo o študiji MDTP-T20091B, ki je bila farmakokinetična študija na 48 zdravih prostovoljcih, ki jo je sponzoriralo podjetje Meditop.
Tolperisone is metabolised by the cytochrome P450 system in particular CYP2D6. 
Tolperizon presnavlja sistem citokroma P450, predvsem CYP2D6.
The CHMP considered that it was not clear whether tolperisone has also been registered in other EU countries or only in the countries mentioned by the MAH. 
Odbor za zdravila za uporabo v humani medicini meni, da ni bilo jasno, ali je bil tolperizon registriran tudi v drugih državah EU ali samo v državah, ki jih je navedel imetnik dovoljenja za promet z zdravilom.
The other papers contain results of various observational studies, congress reports, and surveys (published in Hungarian). 
Drugi dokumenti vsebujejo rezultate različnih opazovalnih študij, poročila s kongresov in raziskave (objavljene v madžarskem jeziku).
Some information on the safety of tolperisone can only be collected from the publications submitted to support the use of tolperisone in selected indications, mentioned above. 
Nekaj informacij o varnosti tolperizona je mogoče zbrati samo iz objav, predloženih za utemeljitev uporabe tolperizona v izbranih indikacijah, navedenih zgoraj.
From these 6 papers only one (Stamenova et al. 2005) was published in an international peer reviewed journal. 
Izmed teh šestih dokumentov je bil samo eden (Stamenova in dr. 2005) objavljen v mednarodni strokovno pregledani reviji.
In summary, there are no data on PK/PD relationship, no confirmation of sufficient efficacy and safety in such a variable PK and the dosing has not been properly selected, as well. 
Če povzamemo, ni podatkov o razmerju med famakokinetiko in farmakodinamiko, nobene potrditve zadostne učinkovitosti in varnosti pri tako variabilni farmakokinetiki, prav tako pa ni bilo pravilno izbrano odmerjanje.
In this trial tolperisone in dose of 300 mg daily proved to be significantly superior to placebo in treatment of painful reflex muscle spasm, in patients with diseases of the spine column or proximal joints. 
V tem preskušanju se je tolperizon v odmerku 300 mg dnevno izkazal za znatno boljšega od placeba pri zdravljenju bolečega refleksnega mišičnega spazma, pri bolnikih z obolenji hrbtenice ali proksimalnih sklepov.
Question 1 - The MAH was asked to demonstrate efficacy and safety in the claimed indication. 
Vprašanje 1 - Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj dokaže učinkovitost in varnost v navedeni indikaciji.
The PK parameters have been compared to the innovator product however the results of the PK study had not been included. 
Farmakokinetične parametre se je primerjalo z inovatorskim zdravilom, vendar rezultati farmakokinetične študije niso bili vključeni.
Thirteen cases of more serious side effects (allergic/hypersensitivity reactions) have also been published in the literature; the detailed analysis of the safety profile of tolperisone, including these serious adverse reactions, is missing from the documentation submitted. 
V literaturi je bilo objavljeno tudi trinajst primerov resnejših neželenih učinkov (alergijske/preobčutljivostne reakcije); v predloženi dokumentaciji manjka podrobna analiza varnostnega profila tolperizona, vključno s temi resnimi neželenimi reakcijami.
However in this trial the majority of the patients had taken tolperisone in higher dose than recommended in the SPC of the originator product. 
Vendar pa je v tem preskušanju večina bolnikov jemala tolperizon v večjem odmerku, kot je bilo priporočeno v povzetku glavnih značilnosti originatorskega zdravila.
The CHMP recommended the refusal of the granting of the Marketing Authorisation in the Concerned Member States and the revocation of the Marketing Authorisation for Myderison where the product is currently authorised. 
je Odbor za zdravila za uporabo v humani medicini priporočil zavrnitev odobritve dovoljenja za promet v zadevnih državah članicah in razveljavitev dovoljenja za promet za zdravilom Myderison tam, kjer je zdravilo trenutno odobreno.
These data show that tolperisone was well tolerated in clinical use, and the side effects (generalized body weakness, fatigue, and dizziness) observed in these clinical trials were usually mild or moderate and did not necessitate the discontinuation of the treatment. 
Ti podatki kažejo, da so bolniki pri klinični uporabi tolperizon dobro prenašali, neželeni učinki (splošna telesna šibkost, utrujenost in vrtoglavica), opaženi v teh kliničnih preskušanjih, pa so bili običajno blagi ali zmerni in zaradi njih ni bilo potrebno prekiniti zdravljenja.
Based on the submitted data it can not be ignored that tolperisone might represent an effective and relatively safe treatment option of spasticity and painful reflex spasm due to organic neurological disorders or accompanying locomotor diseases but the poor quality of the clinical trials and data presentations make it difficult to give a general recommendation on the proper use of tolperisone in the indication claimed by the MAH. 
Na podlagi predloženih podatkov ni mogoče prezreti, da bi lahko tolperizon morda predstavljal učinkovito in sorazmerno varno možnost zdravljenja spastičnosti in bolečih refleksnih spazmov zaradi organskih nevroloških obolenj ali spremljevalnih bolezni lokomotornega sistema, vendar pa je zaradi slabe kakovosti kliničnih preskušanj in predstavitve podatkov težko dati splošno priporočilo za primerno uporabo tolperizona pri indikaciji, ki jo je navedel imetnik dovoljenja za promet z zdravilom.
The clinical relevance of interindividual variability of tolperisone PK and the potential impact of CYP2D6 polymorphism of the drug are unknown. 
Klinična pomembnost intraindividualne variabilnosti farmakokinetike tolperizona in morebitni vpliv polimorfizma CYP2D6 zdravila nista znana.
The CHMP acknowledged that there is a lack of reliable dose finding studies in publicly available sources but did not find enough justifications to support the claimed daily dose recommendation. 
Odbor za zdravila za uporabo v humani medicini ugotavlja, da v javno dostopnih virih primanjkujejo zanesljive študije o ugotavljanju odmerka, vendar ni našel dovolj utemeljitev za podporo navedenega priporočila dnevnega odmerka.
The MAH presented in its response the extent of the tolperisone use in some European countries. 
Imetnik dovoljenja za promet z zdravilom je v svojem odgovoru predstavil obseg uporabe tolperizona v nekaterih evropskih državah.
In the response document to CHMP list of questions, the MAH did not pursuit of presenting full text of scientific articles to be evaluated. 
V dokumentu z odgovorom na seznam vprašanj, ki jih je zastavil Odbor za zdravila za uporabo v humani medicini, si imetnik dovoljenja za promet z zdravilom ni prizadeval predstaviti celega besedila znanstvenih člankov, da se jih oceni.
The sources were not validated, not all the MAHs and data related to non various generic products were included. 
Viri niso bili potrjeni, poleg tega niso bili vključeni vsi imetniki dovoljenja za promet z zdravilom in podatki v zvezi z neraznolikimi generičnimi zdravili.
The trial was a placebo controlled, randomised, double blind dose-titration study of high standard. 
Preskušanje je bila opravljeno s študijo, ki je bila kontrolirana s placebom , randomizirana in dvojno slepa študija visokega standarda za titracijo odmerka.
Tolperisone is a centrally acting muscle relaxant indicated in the spasticity of the skeletal muscles. 
Tolperizon je centralno delujoč mišični relaksant, indiciran pri spastičnosti skeletnih mišic.
The article has scientific merit and seems to support the efficacy of tolperisone in decreasing of spasticity of the skeletal muscles due to post-cerebral stroke. 
Članek ima znanstveno vrednost in zdi se, da podpira učinkovitost tolperizona pri zmanjševanju spastičnosti skeletnih mišic po možganski kapi.
Regarding the metabolic profile of tolperisone the in vitro data which are discussed in the response document do not substitute for the in vivo interaction studies and do not allow conclusive on possible PK or PD drug-drug interactions. 
Glede presnovnega profila tolperizona podatki in vitro, ki so obravnavani v dokumentu z odgovorom, ne nadomeščajo študij medsebojnega delovanja in vitro in ne omogočajo zaključkov o morebitni farmakokinetiki ali farmakodinamiki medsebojnega delovanja z drugimi zdravili.
Question 5 - The MAH was asked to present the quantitative aspects of the use of the substance within the community. 
Vprašanje 5 - Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži količinske vidike uporabe učinkovine v Skupnosti.
In view of the above the CHMP considered that information to justify the proposal for section 4.5 of the SPC was missing and therefore no conclusions could be reached on this regards. 
Glede na navedeno Odbor za zdravila za uporabo v humani medicini meni, da niso bile predložene informacije, ki bi upravičile predlog za poglavje 4.5 povzetka glavnih značilnosti zdravila in zato ni bilo mogoče sprejeti zaključkov.
Question 2 - The MAH had to provide sufficient information on pharmacokinetics of tolperisone hydrochloride and comment on the relevance of bibliographic data submitted which concern a product different from Myderison. 
Vprašanje 2 - Imetnik dovoljenja za promet z zdravilom je moral predložiti zadostne informacije o farmakokinetiki tolperizon hidroklorida in pojasniti pomembnost predloženih bibliografskih podatkov, ki zadevajo proizvod, drugačen od zdravila Myderison.
The MAH proposed a 3-fold higher dose than in the approved German PI for the innovator. 
Imetnik dovoljenja za promet z zdravilom je predlagal trikrat višje odmerke kot v odobrenih nemških informacijah o inovatorskem zdravilu.