natgillin/translations-raw huggingface dataset:
- After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%. 
- Po peroralni uporabi se celotna radioaktivnost v glavnem izloči v blatu (79 %), v urinu pa se izloči le 20 %.
The dose without toxic effect was 3 mg/kg/day. 
Odmerek brez toksičnega učinka je bil 3 mg/kg/dan.
4 mg/2 ml [up to 10] vials/ampoules 
4 mg/2 ml [do 10] viale/ampule
The treatment duration is limited to 5 consecutive days. 
Trajanje zdravljenja je omejeno na 5 zaporednih dni.
This is because the medicine passes into your breast-milk. 
Zdravilo namreč prehaja v materino mleko.
Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy. 
Zdravnik vas bo seznanil z vsemi ukrepi v zvezi z učinkovito kontracepcijo in o možnih tveganjih za zanositev.
The treatment duration is limited to 7 consecutive days. 
Trajanje zdravljenja je omejeno na 7 zaporednih dni.
Therefore, the potential hazards for the embryo and foetus are unknown. 
Zato možna tveganja za zarodek in plod niso znana.
The carcinogenic potential was not evaluated. 
Kancerogenosti niso preučili.
The corresponding values of AUC are respectively 283 and 417 ng.h/mL. 
Ustrezni vrednosti AUC sta 283 in 417 ng.h/ml.
Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed. 
Bolnike je treba natančno seznaniti z možnimi tveganji v primeru morebitne nosečnosti in z učinkovitimi kontracepcijskimi ukrepi, ki jih je treba upoštevati.
It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions. 
Uporabljamo ga pri odraslih in mladostnikih od 16. leta dalje kot dodatno zdravljenje bolečih mišičnih krčev.
You should not use this medicine at higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms). 
Tega zdravila ne smete uporabljati v večjem odmerku ali dlje kot 7 dni (peroralne oblike) oziroma 5 dni (intramuskularne oblike).
o For the oral form 4 mg and 8 mg: 
o Za peroralno obliko 4 mg in 8 mg:
There are limited data on the use of thiocolchicoside in pregnant women. 
Podatkov o uporabi tiokolhikozida pri nosečnicah je malo.
This is based on laboratory studies (see section 2 “Warnings and precautions”). 
Ta ugotovitev temelji na laboratorijskih študijah (glejte 2. poglavje, "Opozorila in previdnostni ukrepi").
You can also report side effects directly via {the national reporting system listed in Appendix V}*. 
O neželenih učinkih lahko poročate tudi neposredno na {nacionalni center za poročanje, ki je naveden v Prilogi V}*.
Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification). 
Poleg tega so opažali manjše nepravilnosti (nadštevilna rebra, zapoznelo osifikacijo).
Method of administration [To be completed nationally] 
Način uporabe [Izpolni država članica]
[the currently approved indications should be deleted and replaced by the following] 
[Trenutno odobreno besedilo je treba izbrisati in zamenjati z naslednjim besedilom]
o For intramuscular form: 
o Za intramuskularno obliko:
This medicine should not be used for long-term treatment (see section 2 “Warnings and precautions”). 
Tega zdravila se ne sme uporabljati za dolgotrajno zdravljenje (glejte 2. poglavje, "Opozorila in previdnostni ukrepi").
8 mg [up to 14] hard capsules [up to14] orodispersible tablets 
8 mg [do 14] trde kapsule [do 14] orodisperzibilne tablete
The presence of the aglycon metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been assessed, therefore its formation using this route of administration can not be excluded. 
Prisotnost aglikonskega presnovka (3-demetiltiokolhicin - SL59.0955) po intramuskularni aplikaciji ni bila nikoli raziskana, zato njegove tvorbe z uporabo tega načina aplikacije ni mogoče izključiti.
Paediatric population <Invented name> should not be used in children and adolescents under 16 years of age because of safety concerns (see section 5.3). 
Zdravila <Izmišljeno ime> se zaradi pomislekov v zvezi z varnostjo ne sme uporabljati pri otrocih in mladostnikih do 16. leta starosti (glejte poglavje 5.3).
Please discuss with your doctor if you have further questions. 
Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Do not give this medicine to children and adolescents below 16 years old because of safety concerns. 
Tega zdravila zaradi pomislekov v zvezi z varnostjo ne smete dajati otrokom in mladostnikom do 16. leta starosti.
<Invented name> is contraindicated during pregnancy and in women of childbearing potential not using contraception (see section 4.3). 
Zdravilo <Izmišljeno ime> je kontraindicirano med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection 
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za trde kapsule/tablete/orodisperzibilne tablete in raztopino za injiciranje
For both metabolites, maximum plasma concentrations occur 1hour after thiocolchicoside administration. 
Oba presnovka dosežeta največjo koncentracijo v plazmi 1 uro po uporabi tiokolhikozida.
For SL59.0955 these values are much lower: Cmax around 13 ng/mL and AUC ranging from 15.5 ng.h/mL (until 3h) to 39.7 ng.h/mL (until 24h). 
Za presnovek SL59.0955 sta ti vrednosti veliko nižji: Cmax okoli 13 ng/ml in AUC od 15,5 ng.h/ml (do 3 ure) do 39,7 ng.h/mL (do 24 ur).
o Both for oral and for intramuscular forms: 
o Za peroralno in intramuskularno obliko:
In the rat, an oral dose of 12 mg/kg/day of thiocolchicoside caused major malformations along with foetotoxicity (retarded growth, embryo death, impairment of sex distribution rate). 
Pri podganah je odmerek 12 mg/kg/dan tiokolhikozida povzročil pomembne malformacije in fetotoksičnost (upočasnjeno rast, smrt zarodka, okvaro deleža spolne porazdelitve).
Do not take this medicine if: - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception 
Ne jemljite tega zdravila: - če ste noseči, bi lahko zanosili, ali mislite, da ste noseči, - če ste ženska v rodni dobi in ne uporabljate kontracepcije.
- After oral administration, no thiocolchicoside is detected in plasma. 
- Po peroralni uporabi tiokolhikozid ni zaznaven v plazmi.
Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration. 
Profil tiokolhikozida so preučili in vitro ter in vivo po parenteralni in peroralni uporabi.
This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes). 
Vzrok za to je, da lahko ena od snovi, ki v telesu nastanejo med jemanjem velikih odmerkov tiokolhikozida, okvari nekatere celice (povzroči nenormalno število kromosomov).
SL59.0955 is also demethylated into didemethyl-thiocolchicine. 
SL59.0955 se tudi demetilira v didemetil-tiokolhicin.
Thiocolchicoside must not be used - in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1 - during the entire pregnancy period - during lactation - in women of childbearing potential not using contraception. 
Tiokolhikozida se ne sme uporabljati - pri bolnikih, preobčutljivih na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju - med celotno nosečnostjo - med obdobjem dojenja - pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom,, farmacevtom ali z medicinsko sestro.
In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility. 
Pri človeku je takšna okvara celic dejavnik tveganja za raka, okvaro pri nerojenem otroku in okvaro plodnosti pri moškem.
This step mainly occurs by intestinal metabolism explaining the lack of circulating unchanged thiocolchicoside by this route of administration. 
To se v glavnem zgodi z intestinalno presnovo; to pojasni, zakaj pri tej poti uporabe v obtoku ni nespremenjenega tiokolhikozida.
This medicine might cause problems to the male fertility due to potential damage to sperm cells (abnormal number of chromosomes). 
To zdravilo lahko povzroči težave s plodnostjo pri moškem, ker lahko okvari semenčice (nenormalno število kromosomov).
No data are available for the inactive metabolite SL59.0955. 
Podatkov za neaktivni presnovek SL59.0955 ni.
SL59.0955 is then glucuroconjugated into SL18.0740 which has equipotent pharmacological activity to thiocolchicoside and thus supports the pharmacological activity after oral administration of thiocolchicoside. 
SL59.0955 se nato glukurokonjugira v SL18.0740, ki ima ekvipotentno farmakološko delovanje kot tiokolhikozid in tako podpira farmakološko delovanje po peroralni uporabi tiokolhikozida.
As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided (see section 4.2). 
Zaradi previdnosti se je treba izogniti uporabi zdravila v odmerkih, večjih od priporočenega odmerka in dolgotrajni uporabi (glejte poglavje 4.2).
Do not take X if: - you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception - you are breast feeding 
Ne jemljite zdravila X: - če ste alergični na tiokolhikozid ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če ste noseči, bi lahko zanosili, ali mislite, da ste noseči - če ste ženska v rodni dobi in ne uporabljate kontracepcije - če dojite
Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955. 
Opažali so le dva presnovka: farmakološko aktivni presnovek SL18.0740 in neaktivni presnovek SL59.0955.
The aneugenic effect of SL59.0955 was observed at concentrations in the in vitro test and at exposures in the in vivo test close to those observed in human plasma at therapeutic doses of 8 mg twice daily per os. Aneugenic effect in dividing cells may result in aneuploid cells. 
Anevgenični učinek SL59.0955 so opažali v koncentracijah, ki so bile pri testu in vitro in pri izpostavljenosti v testu in vivo blizu koncentracijam, opaženim v človeški plazmi med peroralno uporabo terapevtskih odmerkov 8 mg dvakrat na dan. Anevgenični učinek v delečih se celicah lahko povzroči nastanek anevploidnih celic.
After oral administration of thiocolchicoside, the SL18.0740 metabolite is eliminated with an apparent t1/2 ranging from 3.2 to 7 hours and the metabolite SL59.0955 has a t1/2 averaging 0.8h. 
Po peroralni uporabi tiokolhikozida se presnovek SL18.0740 odstrani z navideznim t1/2 v razponu od 3,2 do 7 ur, presnovek SL59.0955 pa ima povprečen t1/2 0,8 ure.
Thiocolchicoside was well tolerated following oral administration for periods of up to 6 months in both the rat and the non-human primate when administered at repeated doses of less than or equal to 2 mg/kg/day in the rat and less or equal to 2.5 mg/kg/day in non-human primate, and by the intramuscular route in the primate at repeated doses up to 0.5 mg/kg/day for 4 weeks. 
Podgane in živalski primati so tiokolhikozid po peroralni uporabi dobro prenašali v obdobju do 6 mesecev med prejemanjem ponavljajočih se odmerkov, manjših ali enakih 2 mg/kg/dan pri podganah in manjših ali enakih 2,5 mg/kg/dan pri živalskih primatih, ter med intramuskularno uporabo pri primatih v ponavljajočih se odmerkih do 0,5 mg/kg/dan 4 tedne.
Distribution The apparent volume of distribution of thiocolchicoside is estimated around 42.7 L after an IM administration of 8 mg. No data are available for both metabolites. 
Ocenjeni navidezni volumen porazdelitve tiokolhikozida po intramuskularni uporabi 8 mg je okoli 42,7 l. Podatkov za presnovka ni.
The aneugenic effect of SL18.0740 was observed at concentrations in the in vitro test and at AUC plasma exposures in the in vivo test higher (more than 10 fold based on AUC) than those observed in human plasma at therapeutic doses. 
Anevgenični učinek SL18.0740 so opažali v koncentracijah, ki so bile pri testu in vitro in plazemski izpostavljenosti AUC v testu in vivo višje (več kot 10-krat na podlagi AUC), kot so opažene v človeški plazmi po terapevtskih odmerkih.
[the wording below should be inserted] 
[Spodnje besedilo je treba vstaviti]
SL18.0740 and SL59.0955 are found in urine and feces while the didemethyl-thiocolchicine is only recovered in feces. 
SL18.0740 in SL59.0955 se pojavita v urinu in blatu, didemetil-tiokolhicin pa se pojavi le v blatu.
In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg, i.e. at dose levels inducing no clinical effect. 
V študiji plodnosti pri podganah niso ugotovili okvare plodnosti v odmerkih do 12 mg/kg, tj. v odmerkih, ki ne povzročijo kliničnega učinka.
Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see section 4.3). 
Tiokolhikozid prehaja v materino mleko, zato je njegova uporaba med obdobjem dojenja kontraindicirana (glejte poglavje 4.3).
Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impairment of human fertility (see section 5.3). 
Tiokolhikozid in njegovi presnovki delujejo anevgenično v različnih koncentracijah in to je dejavnik tveganja za okvaro plodnosti pri človeku (glejte poglavje 5.3).
In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg/day, i.e. at dose levels inducing no clinical effect. 
V študiji plodnosti pri podganah niso ugotovili okvare plodnosti v odmerkih do 12 mg/kg/dan, tj. v odmerkih, ki ne povzročijo kliničnega učinka.
Do not take a double dose to make up for a forgotten dose. 
Če ste pozabili vzeti zdravilo X Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
No unchanged thiocolchicoside is excreted either in urine or feces. 
Ne v urinu ne v blatu se ne izloči nič nespremenjenega tiokolhikozida.
Biotransformation After oral administration, thiocolchicoside is first metabolized in the aglycon 3demethyltiocolchicine or SL59.0955. 
Po peroralni uporabi se tiokolhikozid najprej presnovi v aglikon 3-demetiltiokolhicin ali SL59.0955.
Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is recognised as a risk factor for impairment of human fertility. 
Tiokolhikozid in njegovi presnovki delujejo anevgenično v različnih koncentracijah in to je ugotovljen dejavnik tveganja za okvaro plodnosti pri človeku.
If you accidentally take more X than you should talk to your doctor, pharmacist or nurse. 
Če ste vzeli večji odmerek zdravila X, kot bi smeli Če pomotoma vzamete večji odmerek zdravila X, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
It is to be used for acute conditions related to spinal column. 
Namenjeno je za uporabo pri akutnih obolenjih hrbtenice.
Aneuploidy is considered as a risk factor for teratogenicity, embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer. 
Anevploidija je ugotovljen dejavnik tveganja za teratogenost, embrio- in fetotoksičnost, spontane splave in okvarjeno plodnost moških in kot možen dejavnik tveganja za raka.
In the rabbit, thiocolchicoside showed maternotoxicity starting from 24 mg/kg/day. 
Pri kuncih je bil tiokolhikozid toksičen za samice matere od odmerka 24 mg/kg/dan.
Elimination - After IM administration the apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h. 
Izločanje - Po intramuskularni uporabi je navidezni t1/2 tiokolhikozida 1,5 ure, njegov plazemski očistek pa 19,2 l/h.
Absorption - After IM administration, thiocolchicoside Cmax occur in 30 min and .reach values of 113 ng/mL after a 4 mg dose and 175 ng/mL after a 8 mg dose. 
Absorpcija - Po intramuskularni uporabi se največja koncentracija tiokolhikozida v plazmi pojavi v 30 minutah in doseže 113 ng/ml po odmerku 4 mg in 175 ng/ml po odmerku 8 mg.
The pharmacologically active metabolite SL18.0740 is also observed at lower concentrations with a Cmax of 11.7 ng/mL occurring 5 h post dose and an AUC of 83 ng.h/mL. 
Farmakološko aktivni presnovek SL18.0740 se tudi pojavi, in sicer v nižji koncentraciji (Cmax 11,7 ng/ml) 5 ur po odmerku in z AUC 83 ng.h/ml.
The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH centromere staining), suggesting aneugenic properties. 
Mikrojedra so nastala pretežno zaradi izgube kromosomov (centromerno pozitivna mikrojedra po barvanju centromerov FISH), kar nakazuje anevgenične lastnosti.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets 
Dopolnitve, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH or CREST centromere staining), suggesting aneugenic properties. 
Mikrojedra so nastala pretežno zaradi izgube kromosomov (centromerno pozitivna mikrojedra po barvanju centromerov FISH ali CREST), kar nakazuje anevgenične lastnosti.
After a single oral dose of 8 mg of thiocolchicoside the Cmax and AUC of SL18.0740 are about 60 ng/mL and 130 ng.h/mL respectively. 
Po posamičnem peroralnem odmerku 8 mg tiokolhikozida je Cmax presnovka SL18.0740 približno 60 ng/ml in njegova AUC 130 ng.h/ml.
The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day). 
Priporočeni in največji odmerek je 8 mg na 12 ur (tj. 16 mg na dan).
If you forget to take X 
Kako jemati zdravilo X
o Both for oral and for IM: Doses exceeding recommended doses or long-term use should be avoided (see section 4.4). 
o Za peroralno in intramuskularno obliko: Izogniti se je treba uporabi odmerkov, večjih od priporočenih in dolgotrajni uporabi (glejte poglavje
After repeated administration, thiocolchicoside induced gastro-intestinal disorders (enteritis, emesis) by oral route and emesis by IM route. 
Po ponavljajoči se uporabi je tiokolhikozid povzročil gastrointestinalne motnje (enteritis, bruhanje) po peroralni uporabi in bruhanje po intramuskularni uporabi.
The recommended and maximal dose is 4 mg every 12 hours (i.e. 8 mg per day). 
Priporočeni in največji odmerek je 4 mg na 12 ur (tj. 8 mg na dan).
The major glucuro-conjugated metabolite SL18.0740 did not induce gene mutation in bacteria (Ames test); however it induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus test in mouse bone marrow administered orally). 
Glavni glukurokonjugirani presnovek SL18.0740 ni povzročil genskih mutacij pri bakterijah (Amesov test), povzročil pa je kromosomske okvare in vitro (mikrojedrni preizkus na človeških limfocitih in vitro) in kromosomske okvare in vivo (mikrojedrni preizkus v mišjem kostnem mozgu in vivo, apliciran peroralno).
4.4 Special warnings and precautions for use 
4.4 Posebna opozorila in previdnostni ukrepi [Spodnje besedilo je treba vstaviti]
Contents of the pack and other information [the currently approved wording should be deleted and replaced by the following] 30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose. 
Vsebina pakiranja in dodatne informacije [Trenutno odobreno besedilo je treba izbrisati in zamenjati z naslednjim besedilom] 30 tablet/kapsul za 4 mg odmerek in 14 tablet/kapsul za 8 mg odmerek 10 viale/ampule za 4 mg / 2 ml odmerka.
The aglycon metabolite (3-demethylthiocolchicine-SL59.0955) formed mainly after oral administration induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo oral micronucleus test in rat bone marrow administred orally). 
Aglikonski presnovek (3-demetiltiokolhicin - SL59.0955), ki nastane v glavnem po peroralni uporabi, je povzročil kromosomske okvare in vitro (mikrojedrni preizkus na človeških limfocitih in vitro) in kromosomske okvare in vivo (peroralni mikrojedrni test v podganjem kostnem mozgu in vivo).
This is because this medicine may harm your unborn child. Do not take this medicine if you are breast-feeding. 
To zdravilo namreč lahko škoduje vašemu nerojenemu otroku.
Thiocolchicoside itself did not induce gene mutation in bacteria (Ames test), in vitro chromosomal damage (chromosome aberration test in human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus in mouse bone marrow administered intraperitoneally). 
Tiokolhikozid sam ni povzročil genskih mutacij pri bakterijah (Amesov test), kromosomskih okvar in vitro (test kromosomskih aberacij na človeških limfocitih) in kromosomskih okvar in vivo (mikrojedrni preizkus v mišjem kostnem mozgu in vivo, apliciran intraperitonealno).
Aneuploidy is a modification in the number of chromosomes and loss of heterozygosity, which is recognized as a risk factor for teratogenicity, embryotoxicity/ spontaneous abortion, impaired male fertility, when impacting germ cells and a potential risk factor for cancer when impacting somatic cells. 
To je ugotovljen dejavnik tveganja za teratogenost, embriotoksičnost/spontani splav, okvarjeno plodnost moških v primeru vpliva na klične celice in možen dejavnik tveganja za raka v primeru vpliva na somatske celice.
How to take X [the currently approved wording should be deleted and replaced by the following] 
Kaj je zdravilo X in za kaj ga uporabljamo [Trenutno odobreno besedilo je treba izbrisati in zamenjati z naslednjim besedilom] To zdravilo je mišični relaksant.
At high doses, thiocolchicoside induced emesis in dog, diarrhoea in rat and convulsions in both rodents and non-rodents after acute administration by oral route. 
Po akutni peroralni uporabi velikih odmerkov je tiokolhikozid povzročil bruhanje pri psih, drisko pri podganah ter konvulzije pri glodalcih in neglodalcih.
unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily per os (see section 5.3). 
Predklinične študije so pokazale, da je eden od presnovkov tiokolhikozida (SL59.0955) povzročil anevploidijo (tj. neenako število kromosomov v delečih se celicah) v koncentracijah, ki so bile blizu človeški izpostavljenosti, opaženi med peroralno uporabo odmerkov 8 mg dvakrat na dan (glejte poglavje 5.3).
Posology o For the oral form 4 mg and 8 mg: The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day). 
o Za intramuskularno obliko: Priporočeni in največji odmerek je 4 mg na 12 ur (tj. 8 mg na dan).
CLINICAL PARTICULARS 
Pediatrična populacija
Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards. 
KLINIČNI PODATKI 4.1 Terapevtske indikacije [Trenutno odobrene indikacije je treba izbrisati in zamenjati z naslednjim besedilom] Adjuvantno zdravljenje bolečih mišičnih krčev pri akutnih spinalnih obolenjih pri odraslih in mladostnikih od 16. leta dalje.
4.3 Contraindications 
4.3 Kontraindikacije [Spodnje besedilo je treba vstaviti]
PACKAGE LEAFLET 
Porazdelitev
Gran Vía Carlos III, 98 - 7ª 08028 Barcelona Spain 
Gran Vía Carlos III, 98 - 7ª 08028 Barcelona Španija
The calculations for the minor species turkeys were not considered further in this referral as the risk in any case will be lower. 
Izračuni za purane kot skupine MUMS se v tem napotitvenem postopku niso nadalje obravnavali, saj bo tveganje v vsakem primeru manjše.
Effect studies and calculation of PNEC values 
Študije učinka in izračun vrednosti PKBU