natgillin/translations-raw huggingface dataset:
Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Klavulanska kislina, sicer naravno prisotna snov, je zaviralec betalaktamaze in kemični sinergist za amoksicilin.
and gastrointestinal infections caused by Clostridium spp., E. coli and Salmonella spp.
in Streptococcus spp., občutljivi za kombinacijo amoksicilina in klavulanske kisline, ter zdravljenje okužb prebavil, ki jih povzročajo Clostridium spp., E. coli in Salmonella spp.
This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of STRENZEN 500/125 mg/g powder for use in drinking water for pigs due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the product.
Napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES je bil sprožen zaradi skrbi, da predlagatelj ni zadovoljivo dokazal, da je zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče varno za okolje, saj ni predložil ključnih podatkov, na podlagi katerih bi lahko ocenili varnost zdravila za okolje.
The PECgroundwater for both compounds was above the trigger value 0.1 μg/l (PECgroundwater for amoxicillin was 95.40 μg/l and for clavulanic acid 3.27 μg/l).
PECpodtalnica je bila za obe spojini nad mejno vrednostjo 0,1 μg/l (PECpodtalnica za amoksicilin je bila 95,40 μg/l, za klavulansko kislino pa 3,27 μg/l).
A PECsurfacewater refined by FOCUS modelling and corrected as a sum of predicted surface water concentration of amoxicillin and clavulanic acid (combination) was calculated as 0.036 μg/l.
Vrednost PECpovršinska voda, natančneje izračunana z modelom FOCUS in predstavljena kot vsota predvidenih koncentracij v površinski vodi za amoksicilin in klavulansko kislino (kombinacija), je znašala 0,036 μg/l.
PECsoil (combination) was 1086 μg/kg.
Vrednost PECtla (za kombinacijo) je bila 1086 μg/kg.
The metabolites of amoxicillin are not considered to pose a higher risk than the parent compound, therefore the presented ERA is considered the worst case scenario and is acceptable, despite the fact that it does not take into account the transformation products of the active substance.
Presnovki amoksicilina naj ne bi predstavljali večjega tveganja kot izhodna spojina, zato so ocenili, da je bil v predloženi oceni tveganja za okolje upoštevan najslabši možni primer in da je ocena sprejemljiva, čeprav ne vključuje produktov pretvorbe zdravilne učinkovine.
The environmental risk assessment indicates that the product will not pose an unacceptable risk for the environment when used in accordance with the proposed SPC.
Ocena tveganja za okolje kaže, da zdravilo ne predstavlja nesprejemljivega tveganja za okolje, če se uporablja skladno s predlaganim povzetkom glavnih značilnosti zdravila.
This value was subsequently used in calculations of RQs for aquatic organisms.
To vrednost so uporabili za nadaljnje izračune količnikov tveganja za vodne organizme.
The risk quotients (RQs) calculated for terrestrial plants and earthworms were below the trigger value of 1 and the product can be considered as safe for terrestrial organisms.
Količniki tveganja, izračunani za kopenske rastline in deževnike, so bili pod mejno vrednostjo 1, kar pomeni, da je zdravilo varno za kopenske organizme.
The PECsurfacewater (combination) was 32.89 μg/l.
PECpovršinska voda (za kombinacijo) je znašala 32,89 μg/l.
The worst case scenario was also considered the treatment of weaner pigs.
Najslabši možni primer naj bi bil prav tako zdravljenje tekačev/odstavljencev.
The PECsurfacewater was calculated to be 31.80 μg/l for amoxicillin and 1.09 μg/l for clavulanic acid.
PECpovršinska voda, izračunana za amoksicilin, je bila 31,80 μg/l, za klavulansko kislino pa 1,09 μg/l.
Aquatic environment
Vodno okolje
Terrestrial effects studies
Študije vpliva na kopenske organizme
The target species are treated by 20 mg/kg bw of amoxicillin and 5 mg/kg bw of clavulanic acid for 5 consecutive days.
Ciljne vrste se 5 zaporednih dni zdravi z 20 mg amoksicilina/kg telesne mase in 5 mg klavulanske kisline/kg telesne mase.
It can be concluded that the product in not expected to pose a risk to the environment when used according to the recommendations in the SPC.
Zato je mogoče zaključiti, da ni verjetno, da bi zdravilo predstavljalo tveganje za okolje, kadar se uporablja skladno s priporočili v povzetku glavnih značilnosti zdravila.
The refined RQ of 0.7 is below the trigger value of 1, hence the product does not pose a risk for the aquatic environment - surface water.
Natančneje izračunan količnik tveganja je znašal 0,7 in ni presegal mejne vrednosti 1, kar pomeni, da zdravilo ne predstavlja tveganja za vodno okolje oziroma površinsko vodo.
The application in question, submitted via the decentralised procedure, is a generic application according to Art. 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water registered in the Czech Republic (No.96/069/98-C).
Zadevna vloga, ki je bila predložena po decentraliziranem postopku, je generična vloga v skladu s členom 13(1) Direktive 2001/82/ES, kot je bila spremenjena, ki se sklicuje na referenčno zdravilo Amoksiklav 500/125 mg/g prašek za dajanje v vodo za pitje, registrirano v Češki republiki (št. 96/069/98-C).
Therefore, the CVMP recommended the granting of the marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III of the CVMP Opinion.
Zato je CVMP priporočil odobritev dovoljenja za promet z zdravilom STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče in povezanimi imeni; določila glede povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so navedena v Prilogi III tega mnenja.
In order to address the concerns raised by the referral, the applicant provided an adapted ERA for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and further information on the degradation in soil and sorption to soil.
Da bi odpravil zadržke, zaradi katerih je bil sprožen napotitveni postopek, je predlagatelj predložil prilagojeno oceno tveganja za okolje za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče in dodatne podatke o razgradnji ter adsorpciji/desorpciji v tleh.
PECgroundwater (combination) was 98.67 μg/l.
PECpodtalnica (za kombinacijo) je bila 98,67 μg/l.
The refined PECsurfacewater value was used for recalculation of RQ for algae.
Novo vrednost PECpovršinska voda so nato uporabili za ponoven izračun količnika tveganja za alge.
Environmental risk assessment of the product
Ocena tveganja za okolje pri tem zdravilu
The exposure to the environment will be via slurry application onto land.
Do izpostavljenosti okolja zdravilu pride po politju gnojevke po tleh.
The applicant submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Predlagatelj je za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče predložil vlogo za decentralizirani postopek v skladu s členom 13(1) Direktive 2001/82/ES, kakor je bila spremenjena, ki se sklicuje na referenčno zdravilo Amoksiklav 500/125 mg/g prašek za dajanje v vodo za pitje, odobreno v Češki republiki (št. dovoljenja za promet: 96/069/98-C).
The provided study on soil degradation of amoxicillin is considered acceptable even though nonlabelled material was used and the extraction efficiencies were slightly below those recommended in the OECD guideline 307.
Kljub dejstvu, da so uporabili neoznačen material in da je bila učinkovitost ekstrakcije nekoliko manjša od tiste, ki jo priporočajo smernice OECD 307, je bila predložena študija o razgradnji amoksicilina v tleh ocenjena kot sprejemljiva.
The benefit of STRENZEN 500/125 mg/g powder for use in drinking water for pigs is that treatment of infections caused by microorganisms in intensively reared pigs including respiratory diseases can be treated.
Korist zdravila STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče je zdravljenje prašičev v intenzivni reji z okužbami, ki jih povzročajo mikroorganizmi, vključno z boleznimi dihal.
The RQs for daphnids and fish were below the trigger value of 1 but for algae the RQ was above the trigger value.
Količniki tveganja za vodne bolhe in ribe so bili pod mejno vrednostjo 1, za alge pa so presegali mejno vrednost.
The proposed indications for STRENZEN 500/125 mg/g powder for use in drinking water for pigs are treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Predlagani indikaciji za zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče sta zdravljenje okužb dihal, ki jih povzročajo mikroorganizmi Actinobacillus pleuropneumoniae, Pasteurella spp.
STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names contains amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 as active ingredients.
Zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče in povezana imena vsebujejo zdravilni učinkovini amoksicilin in klavulansko kislino (v obliki kalijeve soli) v razmerju 4 : 1.
PECsoil values for clavulanic acid administered in weaner pigs and fattening pigs exceeded the trigger value 100 μg/kg.
Vrednosti PECtla za klavulansko kislino, ki so jo dajali tekačem/odstavljencem in pitancem, so presegale mejno vrednost 100 μg/kg.
These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started.
Ta vprašanja so ostala nerešena, zato je bil sprožen napotitveni postopek v skladu s členom 33(1) Direktive 2001/82/ES, ki je bil predložen Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
No further risk management or mitigation measures are required as a consequence of this referral procedure.
Med napotitvenim postopkom odbor ni ugotovil, da bi bili potrebni dodatni ukrepi za obvladovanje ali zmanjšanje tveganja.
Evaluation of the benefit-risk balance
Vrednotenje razmerja med tveganji in koristmi
STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients.
Zdravilo STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče vsebuje zdravilni učinkovini amoksicilin in klavulansko kislino.
Overall summary of the scientific evaluation of STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Splošni povzetek znanstvenega vrednotenja zdravila STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče
Scientific conclusions and grounds for the granting of the marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Znanstveni zaključki in podlaga za odobritev dovoljenja za promet z zdravilom STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče
Treatment of weaner pigs was considered to be the worst case scenario.
Najslabši možni primer naj bi bil zdravljenje tekačev/odstavljencev.
Predicted environmental concentrations (PECs) of amoxicillin and clavulanic acid in soil were calculated in phase I. All PECsoil values for amoxicillin exceeded the trigger value 100 μg/kg.
Vse vrednosti PECtla za amoksicilin so presegale mejno vrednost 100 μg/kg.
Grounds for the granting of marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs
Podlaga za odobritev dovoljenja za promet z zdravilom STRENZEN 500/125 mg/g prašek za dajanje v vodo za pitje za prašiče
5 May 2009 EMEA/215198/2009
5. maj 2009 EMEA/215198/2009
The final opinion was converted into a Decision by the European Commission on 5 May 2009.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 5. maja 2009.
The Decentralised Procedure IE/V/0200/001/DC started on 19 January 2007.
Decentralizirani postopek IE/V/0200/001/DC se je začel 19. januarja 2007.
Written explanations were provided by the Applicant on 17 November 2008.
Predlagatelj je 17. novembra 2008 predložil pisna pojasnila.
The Rapporteur and Co-Rapporteur appointed were: Dr Anja Holm (Denmark) and Dr Boris Kolar (Slovenia), respectively.
Poročevalec in soporočevalec sta bila dr. Anja Holm (Danska) in dr. Boris Kolar (Slovenija).
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so navedeni v Dodatku II.
The referral procedure started on 14 May 2008.
Napotitveni postopek se je začel 14. maja 2008.
International Non-Proprietary Name (INN): Enrofloxacin
Mednarodno nelastniško ime (INN): Enrofloksacin
On the basis of the grounds for referral, the points considered by the CVMP were:
Na osnovi razlogov za napotitev je CVMP proučil naslednje točke:
• Adequacy of the data available in respect to the environmental risk assessment for blue-green algae and terrestrial plants;
• ustreznost razpoložljivih podatkov v zvezi z oceno okoljskega tveganja za modrozelene alge in kopenske rastline;
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4) ZA ZDRAVILO
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Enrofloksacin je sintetična, širokospektralna protimikrobna učinkovina iz skupine antibiotikov fluorokinolonov.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Ireland and the Concerned Member States were Belgium, Czech Republic, Germany and Poland.
Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kot je bila spremenjena, pri čemer je bila Irska referenčna država članica, Belgija, Češka republika, Nemčija in Poljska pa zadevne države članice.
On 29 April 2008 Ireland, referred the matter to the EMEA under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that enrofloxacin may present a potential serious risk to the environment (risk to blue-green algae and to terrestrial plants).
Irska je dne 29. aprila 2008 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na agencijo EMEA zaradi zadržkov, ki jih je izpostavila Nemčija, in sicer, da enrofloksacin utegne predstavljati morebitno resno tveganje za okolje (tveganje za modrozelene alge in kopenske rastline).
During its 13-15 January 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion that the use of the product as recommended does not constitute a risk for the environment and therefore the points of disagreement raised by Germany should not prevent the granting of a Marketing Authorisation.
Med svojim zasedanjem 13.-15. januarja 2009 je CVMP na podlagi celotnih predloženih podatkov in znanstvene razprave znotraj Odbora soglasno sprejel mnenje, da priporočena uporaba zdravila ne predstavlja tveganja za okolje, zato ugovori, ki jih je izpostavila Nemčija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.
UNISOL 10% ORAL SOLUTION
UNISOL 10% PERORALNA RAZTOPINA
The applicant, Universal Farma S.L., submitted an application for a decentralised procedure for Unisol 10% Oral Solution, indicated for chickens and turkeys and for oral administration via the drinking water.
Predlagatelj, družba Universal Farma S.L., je vlogo za zdravilo Unisol 10% peroralna raztopina, indicirano za kokoši in purane ter peroralno uživanje s pitno vodo, predložil v presojo po decentraliziranem postopku.
• Identification of a potential serious risks to blue-green algae and terrestrial plants arising from the use of Unisol 10% Oral solution.
• ugotavljanje morebitnih resnih tveganj za modrozelene alge in kopenske rastline, ki izhajajo iz uporabe zdravila Unisol 10 % peroralna raztopina.
The Committee limited its considerations to the data presented by the Applicant in the dossier for this product in line with the restrictions in legislation with respect to data on environmental risk.
Odbor je v skladu z zakonskimi omejitvami, ki veljajo za podatke o okoljskih tveganjih, svojo presojo omejil na podatke, ki jih je predstavil predlagatelj v dokumentaciji za to zdravilo.
No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredient.
O uporabnosti teh zaključkov pri drugih odobrenih zdravilih, ki vsebujejo isto zdravilno učinkovino, se ni razpravljalo niti niso bili glede tega sprejeti nobeni sklepi.
July 2020
Julij 2020
Cmax, µg/ml AUC0-t, µg-hr/ml Vz, ml
Cmax, µg/ml AUC0-t, µg-uro/ml Vz, ml
Date of first authorisation: 30 May 2017
Datum prve odobritve: 30. maj 2017
2 years and older
2 leti in starejši
No information is available.
Informacij ni na voljo.
This score signifies a decline from a previous level of ability (from the individual maximum reached by the child).
Ta rezultat pomeni upad s prejšnje ravni sposobnosti (od individualne najvišje ocene, ki jo je otrok dosegel).
Annual reports to be submitted as part of the annual reassessment
ki bodo predložena kot del letne ponovne presoje
0 Can no longer walk or crawl.
Ne more več hoditi ali se plaziti.
Clinical and laboratory monitoring
Klinično in laboratorijsko spremljanje
2 Independent gait, as defined by ability to walk without support for 10 steps.
Neodvisna hoja, kot jo opredeljuje sposobnost hoje 10 korakov brez podpore.
An extension line may be added if needed.
Po potrebi se lahko doda podaljševalna linija.
All infusion components must be sterile.
Vse infuzijske komponente morajo biti sterilne.
This medicine works to slow the progression of the disease.
To zdravilo deluje tako, da upočasni napredovanje bolezni.
No decline noted yet.
Upad še ni opazen.
Effects of the potentially increased medicinal product exposure on the periphery are unknown.
Učinki možnega povečanja izpostavljenosti zdravilu na periferijo niso znani.
1 Hardly understandable.
Skoraj nerazumljivo.
The doctor may decide on additional monitoring if it is needed.
Zdravnik se lahko po potrebi odloči za dodatno spremljanje.
In addition, these investigations included very small animal numbers, mostly tested single dose groups and lacked appropriate controls.
Poleg tega so raziskave vključevale zelo majhno število živali, pri katerih so večinoma testirali skupine z enim odmerkom brez ustreznih kontrol.
Birth to < 6 months 6 months to < 1 year 1 year to < 2 years
od rojstva do < 6 mesecev od 6 mesecev do < 1 leto od 1 leta do < 2 leti
1 Requires external assistance to walk, or can crawl only.
Za hojo potrebuje zunanjo pomoč ali se lahko le plazi.
This medicine may cause other side effects:
To zdravilo lahko povzroči druge neželene učinke:
Please consult your doctor.
Posvetujte se z zdravnikom.
Language has become recognizably abnormal: some intelligible words, may form short sentences to convey concepts, requests, or needs.
Govor je postal razpoznavno nenormalen: nekatere razumljive besede, morda tvori kratke stavke za izražanje konceptov, zahtev ali potreb.
The recommended dose of Brineura is based upon your or your child's age, and is given once every other week as follows:
Priporočeni odmerek zdravila Brineura temelji na vaši ali otrokovi starosti in se ga daje vsak drugi teden, kot sledi:
In people with CLN2 disease, these materials build-up in certain parts of the body, mainly the brain.
Pri ljudeh s CLN2 se te snovi kopičijo v nekaterih delih telesa, pretežno v možganih.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred začetkom prejemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
These precautions are of particular importance in patients below 3 years of age.
Ti previdnostni ukrepi so posebno pomembni pri bolnikih, starih manj kot 3 leta.
Intelligible and grossly age-appropriate.
Razumljiv in povečini ustrezen starosti.
Pre-treatment of patients with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of infusion.
Predzdravljenje bolnikov z antihistaminiki z antipiretiki ali brez njih se priporoča od 30 do 60 minut pred začetkom infundiranja.
Tell your doctor if you or your child is taking, has recently taken, or might take any other medicines.
Obvestite zdravnika, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
It is important to initiate treatment in children as young as possible, although patients less than 3 years of age were not included in the pivotal study.
Pomembno je, da se zdravljenje uvede pri čim mlajših otrocih, čeprav bolniki, stari manj kot 3 leta, niso bili vključeni v osrednjo študijo.
MRI volumetry measurements show attenuated rate of loss.
Meritve MRI volumetrije so pokazale znižano stopnjo izgube.
So far safety results in younger patients appears consistent with the safety profile observed in older children.
Do sedaj se rezultati varnosti pri mlajših bolnikih zdijo skladni s profilom varnosti, ki so ga ugotovili pri starejših otrocih.
• Syringe: Braun and BD Luer-Lok
• injekcijska brizga: Braun in BD Luer-Lok
Condensation will occur during thawing period.
Med postopkom odtajanja se bo pojavila kondenzacija.
CL, ml/hr t1/2, hr
CL, ml/uro t1/2, ure
• Extension Set with 0.2 micron filter: Impromediform GmbH
• podaljševalni set z 0,2-mikronskim filtrom: Impromediform GmbH
Thaw at room temperature and use immediately.
Odtalite pri sobni temperaturi in takoj uporabite.
The dose may be reduced by 50% and/or the infusion rate decreased to a slower rate.
Odmerek je mogoče zmanjšati za 50 % in/ali zmanjšati hitrost infundiranja.
3 Apparently normal language.
Navidezno normalen govor.
Total dose administered every other week (mg)
Skupni odmerek, apliciran vsak drugi teden (mg)
Few intelligible words.
Nekaj razumljivih besed.
When compared to the expected rate of decline based on natural history, the study results are statistically significant (p < 0.0001) (see Table 4).
V primerjavi s pričakovano stopnjo upada na podlagi naravnega poteka so rezultati študije statistično značilni (p < 0,0001) (glejte preglednico 4).
Non-interventional post-authorisation safety study (PASS): Study 190-501.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): študija 190-501.
Inspect the vials to ensure they are fully thawed.
Viale preglejte in se prepričajte, da so povsem odtaljene.
MedDRA Preferred term
MedDRA Prednostni izraz
Inadequate levels of TPP1 cause CLN2 disease, resulting in neurodegeneration, loss of neurological function and death during childhood.
Nezadostne ravni TPP1 povzročajo CLN2, kar ima za posledico nevrodegeneracijo, izgubo nevrološke funkcije in smrt v otroštvu.
Five patients experienced a single point decrease, and 3 patients experienced a 2 point decrease.
Pet bolnikov je imelo upad za eno točko, pri 3 bolnikih pa je bil upad 2 točki.
No patients had to have their treatment discontinued due to adverse events.
Noben od bolnikov ni prekinil zdravljenja zaradi neželenih učinkov.
A syringe volume of 10 to 20 ml is recommended.
Priporoča se volumen injekcijske brizge od 10 do 20 ml.
Age groups
Starostne skupine
This medicine has been authorised under ‘exceptional circumstances'.
Zdravilo je pridobilo dovoljenje za promet v "izjemnih okoliščinah".
The pharmacokinetic parameters in CSF were assessed in 17 patients and are summarized in Table 5 below.
Farmakokinetični parametri v CSL so bili ocenjeni pri 17 bolnikih in so povzeti spodaj v preglednici 5.