natgillin/translations-raw huggingface dataset:
For the full list of side effects and restrictions with Libtayo, see the package leaflet. 
Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Libtayo potražite u uputi o lijeku.
Please discuss with your doctor if you have further questions. 
Molimo razgovarajte sa svojim liječnikom ako imate dodatnih pitanja.
The carcinogenic potential was not evaluated. 
Karcinogeni potencijal nije procijenjen.
This has been shown in studies in animals and in laboratory studies. 
To je dokazano u ispitivanjima na životinjama i u laboratorijskim ispitivanjima.
This medicine is a muscle relaxant. 
Ovaj lijek je mišićni relaksans.
[*For the printed material, please refer to the guidance of the annotated QRD template.] 
[*Za tiskani materijal, molimo pogledajte smjernice naznačenog QRD predloška.]
Always take this medicine exactly as your doctor or pharmacist has told you. 
Uvijek uzmite ovaj lijek točno onako kako vam je rekao vaš liječnik ili ljekarnik.
This is because the medicine passes into your breast-milk. 
To je zato što lijek prelazi u vaše majčino mlijeko.
Do not exceed the recommended doses and treatment duration. 
Nemojte prekoračiti preporučene doze i trajanje liječenja.
The dose without toxic effect was 3 mg/kg/day. 
Doza bez toksičnog učinka bila je 3 mg/kg/dan.
Studies in animals have shown teratogenic effects (see section 5.3). 
Ispitivanja na životinjama pokazala su teratogene učinke (vidjeti dio 5.3).
The treatment duration is limited to 5 consecutive days. 
Trajanje liječenja ograničeno je na 5 uzastopnih dana.
Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed. 
Bolesnike se mora pažljivo informirati o potencijalnim rizicima moguće trudnoće i o djelotvornim mjerama kontracepcije koje je potrebno poduzeti.
The treatment duration is limited to 7 consecutive days. 
Trajanje liječenja ograničeno je na 7 uzastopnih dana.
This is based on laboratory studies (see section 2 “Warnings and precautions”). 
Ovo se temelji na laboratorijskim ispitivanjima (pogledajte dio 2 „Upozorenja i mjere opreza”).
Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy. 
Vaš će vas liječnik informirati o svim mjerama koje su povezane s učinkovitom kontracepcijom i o potencijalnim rizicima kod trudnoće.
Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification). 
Nadalje, opažene su manje abnormalnosti (prekobrojna rebra, zakašnjela osifikacija).
Strictly respect the doses and duration of treatment detailed in section 3. 
Strogo poštujte doze i trajanje liječenja kako je navedeno u dijelu 3.
You should not use this medicine at higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms). 
Ne smijete uzimati ovaj lijek u većim dozama ili dulje od 7 dana (kod oblika lijeka za primjenu kroz usta)/5 dana (kod oblika lijeka za primjenu u mišić).
[this wording should be inserted] 
[Mora se unijeti ovaj tekst]
- After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%. 
- Nakon peroralne primjene, ukupna radioaktivnost je većinom izlučena u stolicu (79%), dok se putem mokraće izluči tek 20%.
There are limited data on the use of thiocolchicoside in pregnant women. 
Postoje ograničeni podaci o primjeni tiokolhikozida u trudnica.
[the currently approved indications should be deleted and replaced by the following] 
[trenutno odobrene indikacije moraju se obrisati i zamijeniti sljedećim]
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*. 
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
[This wording should be inserted] This medicine is subject to additional monitoring. 
[mora se unijeti donji tekst] Ovaj je lijek pod dodatnim praćenjem.
4 mg/2 ml [up to 10] vials/ampoules 
4 mg/2 ml [do 10] bočica/ampula
Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards. 
Adjuvantno liječenje bolnih kontraktura mišića kod akutne spinalne patologije u odraslih i adolescenata u dobi od 16 godina i starijih.
The corresponding values of AUC are respectively 283 and 417 ng.h/mL. 
Odgovarajuće AUC vrijednosti su 283 odnosno 417 ng.h/mL.
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). 
Pedijatrijska populacija <Zaštićeno ime> se, iz sigurnosnih razloga, ne smije primjenjivati u djece i adolescenata mlađih od 16 godina (vidjeti dio 5.3).
o For intramuscular form: 
o Oblici za intramuskularnu primjenu:
4 mg [up to 30] hard capsules [up to 30] tablets 
4 mg [do 30] tvrdih kapsula [do 30] tableta
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). 
To je zato što jedan od produkata koji se stvara u vašem tijelu kad uzimate tiokolhikozid u većim dozama može oštetiti neke stanice (abnormalni broj kromosoma).
For both metabolites, maximum plasma concentrations occur 1hour after thiocolchicoside administration. 
Za oba metabolita, maksimalne koncentracije u plazmi dosegnute su 1 sat nakon primjene tiokolhikozida.
4.6 Fertility, pregnancy and lactation [the currently approved wording should be deleted and replaced by the following] 
4.6 Plodnost, trudnoća i dojenje [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim]
Therefore, the potential hazards for the embryo and foetus are unknown. 
Prema tome, potencijalni rizici za zametak i plod nisu poznati.
This medicine should not be used for long-term treatment (see section 2 “Warnings and precautions”). 
Ovaj se lijek ne smije koristiti za dugotrajno liječenje (pogledajte dio 2 „Upozorenja i mjere opreza”).
Do not give this medicine to children and adolescents below 16 years old because of safety concerns. 
Iz sigurnosnih razloga, nemojte davati ovaj lijek djeci i adolescentima mlađim od 16 godina.
No data are available for the inactive metabolite SL59.0955. 
Nema raspoloživih podataka za neaktivni metabolit SL59.0955.
How to take X [the currently approved wording should be deleted and replaced by the following] 
Kako uzimati X [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim]
Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see section 4.3). 
Budući da prolazi u majčino mlijeko, primjena tiokolhikozida kontraindicirana je za vrijeme dojenja (vidjeti dio 4.3).
This step mainly occurs by intestinal metabolism explaining the lack of circulating unchanged thiocolchicoside by this route of administration. 
To se uglavnom događa intestinalnim metabolizmom što objašnjava nedostatak cirkulirajućeg nepromijenjenog tiokolhikozida kod ovog puta primjene.
Method of administration [To be completed nationally] 
Način primjene [Popuniti u svakoj zemlji posebno]
It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions. 
Primjenjuje se kod odraslih i adolescenata u dobi od 16 godina i starijih kao adjuvantno liječenje bolnih mišićnih kontrakcija.
- After oral administration, no thiocolchicoside is detected in plasma. 
- Nakon peroralne primjene, nije detektiran tiokolhikozid u plazmi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za tvrde kapsule/ tablete/raspadljive tablete za usta i otopinu za injekciju
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 
Nemojte uzeli ovaj lijek ako: - ste trudni, ako biste mogli biti trudni ili mislite da ste trudni, - ste žena u fertilnoj dobi i ne koristite kontracepciju.
It is to be used for acute conditions related to spinal column. 
Primjenjuje se kod akutnih stanja povezanih s kralješnicom.
You can also report side effects directly via {the national reporting system listed in Appendix V}*. 
Nuspojave možete prijaviti izravno putem {nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V}*.
SL59.0955 is also demethylated into didemethyl-thiocolchicine. 
SL59.0955 se također demetilira u didemetil-tiokolhicin.
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 SL59.0955, te su vrijednosti puno niže: Cmax iznosi oko 13 ng/mL dok je AUC u rasponu od 15,5 ng.h/mL (do 3h) do 39,7 ng.h/mL (do 24h).
This medicine might cause problems to the male fertility due to potential damage to sperm cells (abnormal number of chromosomes). 
Ovaj lijek može uzrokovati probleme u muškoj plodnosti radi mogućeg oštećenja spermatozoida (abnormalni broj kromosoma).
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. 
Tiokolhikozid se dobro podnosio nakon peroralne primjene tijekom razdoblja do 6 mjeseci kod štakora i nečovjekolikih primata kad se primjenjivao u ponovljenim dozama manjim ili jednakim 2 mg/kg/dan kod štakora i manjim ili jednakim 2,5 mg/kg/dan kod nečovjekolikih primata, te intramuskularnim putem kod primata u ponovljenim dozama do 0,5 mg/kg/dan tijekom 4 tjedna.
o For the oral form 4 mg and 8 mg: 
Doziranje o Oblici za peroralnu primjenu od 4 mg i 8 mg:
PL 
o
8 mg [up to 14] hard capsules [up to14] orodispersible tablets 
8 mg [do 14] tvrdih kapsula [do14] raspadljivih tableta za usta
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. 
Tiokolhikozid se ne smije upotrebljavati: - u bolesnika preosjetljivih na djelatnu tvar i na bilo koju od pomoćnih tvari navedenih u dijelu 6.1, - za cijelo vrijeme trajanja trudnoće, - za vrijeme dojenja, - u žena fertilne dobi koje ne koriste kontracepciju.
Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955. 
Opažena su samo dva metabolita: Farmakološki aktivni metabolit SL18.0740 i neaktivni metabolit SL59.0955.
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. 
Prisutnost aglikon metabolita (3-demetiltiokolhicinSL59.0955) nakon intramuskularne primjene nije nikad procijenjena, prema tome njegov nastanak pomoću ovog puta primjene ne može se isključiti.
If you accidentally take more X than you should talk to your doctor, pharmacist or nurse. 
Ako slučajno uzmete više X nego što ste trebali, javite to svom liječniku, ljekarniku ili medicinskoj sestri.
In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility. 
Kod ljudi, ovaj tip oštećenja stanica predstavlja faktor rizika za rak, za oštećenja nerođenog djeteta i poremećaj muške plodnosti.
In the rabbit, thiocolchicoside showed maternotoxicity starting from 24 mg/kg/day. 
Kod kunića, tiokolhikozid je pokazao toksičnost za majku počevši od doze od 24 mg/kg/dan.
<Invented name> is contraindicated during pregnancy and in women of childbearing potential not using contraception (see section 4.3). 
<Zaštićeno ime> je kontraindiciran(a) za vrijeme trudnoće i u žena fertilne dobi koje ne koriste kontracepciju (vidjeti dio 4.3).
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). 
Kao mjera opreza, primjena lijeka u dozama većim od preporučene doze ili dugotrajna primjena moraju se izbjegavati (vidjeti dio 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 
Nemojte uzimati X ako: - ste alergični na tiokolhikozid ili bilo koji sastojak ovog lijeka (naveden u dijelu 6), - ste trudni, ako biste mogli biti trudni ili mislite da ste trudni, - ste žena u fertilnoj dobi i ne koristite kontracepciju, - dojite.
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. 
Aneuploidija je modifikacija broja kromosoma i gubitak heterozigotnosti, koji je prepoznat kao faktor rizika za teratogenost, embriotoksičnost/ spontani abortus i poremećaj muške plodnosti kad utječe na zametne stanice i potencijalni faktor rizika za rak kad utječe na somatske stanice.
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). 
U štakora, peroralna doza tiokolhikozida od 12 mg/kg/dan uzrokovala je značajne malformacije i fetotoksičnost (usporeni rast, smrt zametka, poremećaj stope raspodjele spola).
After repeated administration, thiocolchicoside induced gastro-intestinal disorders (enteritis, emesis) by oral route and emesis by IM route. 
Nakon ponovljene primjene, tiokolhikozid je izazvao gastrointestinalne poremećaje (enteritis, emezu) kod primjene peroralnim putem i emezu kod intramuskularne primjene.
o Both for oral and for IM: Doses exceeding recommended doses or long-term use should be avoided (see section 4.4). 
Za peroralnu primjenu i za intramuskularnu primjenu: Doze koje prelaze preporučene doze ili dugotrajna primjena moraju se izbjegavati (vidjeti dio 4.4).
Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration. 
Profil tiokolhikozida procijenjen je in vitro i in vivo nakon parenteralne i peroralne primjene.
The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day). 
Preporučena i maksimalna doza je 8 mg svakih 12 sati (tj. 16 mg na dan).
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 zatim glukurokonjugira u SL18.0740 koji ima ekvipotentnu farmakološku aktivnost na tiokolhikozid i tako potpomaže farmakološku aktivnost nakon peroralne primjene tiokolhikozida.
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. 
Aneugenični učinak SL18.0740 bio je opažen pri koncentracijama u in vitro testu i AUC izloženosti plazme u in vivo testovima više (više nego 10-erostruke doze temeljem AUC-a) nego kod onih primijećenih u ljudskoj plazmi pri terapijskim dozama.
Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is recognised as a risk factor for impairment of human fertility. 
Tiokolhikozid i njegovi metaboliti pokazuju aneugeničnu aktivnost pri različitim koncentracijama, što je prepoznato kao rizični faktor za poremećaj plodnosti u ljudi.
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. 
Aneuploidija se smatra faktorom rizika za teratogenost, embriofetalnu toksičnost, spontani abortus i poremećaj plodnosti kod muškarca i potencijalno rizičnim faktorom za rak.
Biotransformation After oral administration, thiocolchicoside is first metabolized in the aglycon 3demethyltiocolchicine or SL59.0955. 
Biotransformacija Nakon peroralne primjene, tiokolhikozid se prvo metabolizira u aglikon 3-demetiltiokolhicin ili SL59.0955.
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. 
Nakon peroralne primjene tiokolhikozida, metabolit SL18.0740 se eliminira s prividnim t1/2 u rasponu od 3,2 do 7 sati dok metabolit SL59.0955 ima prosječni t1/2 od 0,8 sati.
SL18.0740 and SL59.0955 are found in urine and feces while the didemethyl-thiocolchicine is only recovered in feces. 
SL18.0740 i SL59.0955 su pronađeni u mokraći i stolici dok je didemetil-tiokolhicin pronađen samo u stolici.
The recommended and maximal dose is 4 mg every 12 hours (i.e. 8 mg per day). 
Preporučena i maksimalna doza je 4 mg svakih 12 sati (tj. 8 mg na dan).
See section 4.8 for how to report adverse reactions. 
Za postupak prijavljivanja nuspojava vidjeti dio 4.8
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. 
Pri visokim dozama, tiokolhikozid je izazivao emezu kod pasa, dijareju kod štakora i konvulzije i kod glodavaca i neglodavaca nakon akutne primjene peroralnim putem.
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. 
Apsorpcija - Nakon intramuskularne primjene, Cmax tiokolhikozida postiže se za 30 minuta i doseže vrijednosti od 113 ng/mL nakon doze od 4 mg i 175 ng/mL nakon doze od 8 mg.
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. 
Sadržaj pakiranja i druge informacije [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim] 30 tableta/kapsula za dozu od 4 mg i 14 tableta/kapsula za dozu od 8 mg. 10 bočica/ampula za dozu od 4 mg / 2 ml.
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. 
Farmakološki aktivni metabolit SL18.0740 također je opažen pri nižim koncentracijama uz Cmax od 11,7 ng/mL koji se postiže 5 h nakon doze i AUC od 83 ng.h/mL.
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 i njegovi metaboliti imaju aneugenični učinak pri različitim koncentracijama, što je prepoznato kao rizični faktor za poremećaj plodnosti u ljudi (vidjeti dio 5.3).
Elimination - After IM administration the apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h. 
Eliminacija - Nakon intramuskularne primjene prividni t1/2 tiokolhikozida je 1,5 sati dok je klirens plazme 19,2 L/h.
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. 
Nakon jednokratne peroralne doze od 8 mg tiokolhikozida, Cmax i AUC metabolita SL18.0740 iznose oko 60 ng/mL odnosno 130 ng.h/mL.
This is because this medicine may harm your unborn child. Do not take this medicine if you are breast-feeding. 
To je zato što ovaj lijek može naškoditi vašem nerođenom djetetu.
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. 
U ispitivanjima plodnosti provedenim na štakorima, nije opažen utjecaj na plodnost pri dozama do 12 mg/kg, tj. pri dozama koje ne induciraju klinički učinak.
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. 
U ispitivanjima plodnosti provedenim na štakorima, nije opažen utjecaj na plodnost pri dozama do 12 mg/kg/dan, tj. pri dozama koje ne induciraju klinički učinak.
The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH centromere staining), suggesting aneugenic properties. 
Mikronukleusi su predominantno rezultirali iz gubitka kromosoma (mikronukleusi pozitivni na centromere nakon bojenja centromera metodom FISH), što upućuje na aneugenična svojstva.
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. 
Distribucija Prividni volumen raspodjele tiokolhikozida se procjenjuje na oko 42,7 L nakon i.m. primjene doze od 8 mg.
The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH or CREST centromere staining), suggesting aneugenic properties. 
Mikronukleusi su uglavnom rezultirali iz gubitka kromosoma (mikronukleusi pozitivni na centromere nakon bojenja centromera metodama FISH ili CREST), što upućuje na aneugenična svojstva.
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 metabolit SL18.0740 nije izazvao mutaciju gena kod bakterija (Ames test); međutim, izazvao je in vitro oštećenje kromosoma (in vitro mikronukleus test na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo mikronukleus test u koštanoj srži miševa kod peroralne primjene).
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. 
Aneugenični učinak SL59.0955 opažen je u in vitro testu te kod koncentracija i u in vivo testu pri izloženostima blizu onima opaženim u ljudskoj plazmi pri terapijskim dozama od 8 mg dvaput na dan per os.
No unchanged thiocolchicoside is excreted either in urine or feces. 
Neizmijenjeni tiokolhikozid ne izlučuje se ni putem mokraće ni putem stolice.
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 po sebi nije izazvao mutaciju gena kod bakterija (Ames test), in vitro oštećenje kromosoma (test aberacije kromosoma na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo mikronukleus u koštanoj srži miševa kod intraperitonealne primjene).
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). 
Metabolit aglikon (3-demetiltiokolhicin-SL59.0955) koji nastaje uglavnom nakon peroralne primjene izazvao je in vitro oštećenje kromosoma (in vitro mikronukleus test na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo oralni test mikronukleusa na koštanoj srži miševa kod peroralne primjene).