natgillin/translations-raw huggingface dataset:
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
Application of the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l.
Z uporabo smernice CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje ob smernicah VICH GL6 in GL38 dobimo oceno PKOpovršinska voda 0,019 µg/l.
The seeds were placed in a natural sandy soil containing the test item at nominal concentrations of 10, 31.6, 100, 316 and 1000 mg enrofloxacin/kg dry soil (cucumber, lettuce, mung bean, oat and wheat) and 3, 12, 48, 192 and 768 mg enrofloxacin/kg dry soil (rye), respectively.
Semena so položili v naravno peščeno prst, ki je vsebovala preskušano snov v nazivnih koncentracijah 10, 31,6, 100, 316 in 1 000 mg enrofloksacina/kg suhe prsti (kumara, zelena solata, fižol, oves in pšenica) oziroma 3, 12, 48, 192 in 768 mg enrofloksacina/kg suhe zemlje (rž).
Unisol 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product.
Unisol 10 % peroralna raztopina vsebuje 100 mg enrofloksacina kot zdravilne učinkovine na 1 ml zdravila.
As ciprofloxacin represents only 2% of the total outcome of the enrofloxacin metabolism in chickens it is assumed that any potential risk of metabolites is encompassed by using the total residue approach assuming that the total dose is excreted as parent compound or as metabolites with a toxicity that is similar to the parent compound.
Ker ciprofloksacin predstavlja le 2 % skupne presnove enrofloksacina pri kokoših, se šteje, da so vsa možna tveganja presnovkov zajeta s pristopom vseh ostankov pri predpostavki, da se celotni odmerek izloči kot izhodna spojina ali kot presnovki s toksičnostjo, podobno izhodni spojini.
A study taken from the open literature, Knapp et al (2005)4, indicated that exposure is very low.
Študija Knapp et al. (2005)4 iz dostopne literature kaže, da je izpostavljenost zelo majhna.
A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers.
V študiji, ki je bila objavljena v recenzirani in dostopni literaturi (Nowara et al 1997)1, ugotavljajo, da se enrofloksacin in drugi fluorokinoloni močno vežejo na zemljo z visoko vsebnostjo glinenih mineralov montmorilonita in kaolinita, predvsem z elektrostatskimi interakcijami med ioniziranimi karboksiliranimi skupinami fluorokinolonov ter zamenljivimi kationi v glinenih plasteh.
The applicant provided an environmental risk assessment for Unisol 10% Oral Solution that followed in general the established guidelines and recommendations.
Predlagatelj je predložil oceno tveganja zdravila Unisol 10 % peroralna raztopina za okolje, v katerem je na splošno upošteval uveljavljene smernice in priporočila.
The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Unisol 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment.
V fazi I ocene tveganja za okolje na podlagi smernic VICH so dobljene predvidene koncentracije v okolju (PKO) v zemlji za zdravilo Unisol 10 % peroralna raztopina pri brojlerjih (10 mg/kg telesne mase /dan, 5 dni) nad 100 µg/kg, kar pomeni, da je potrebna ocena faze II.
During the decentralised procedure concerns were raised that Unisol 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants.
Med decentraliziranim postopkom so se pojavili zadržki, da bi lahko zdravilo Unisol 10% peroralna raztopina pomenila resno tveganje za okolje glede na modrozelene alge in kopenske rastline.
If the geometric mean of DT50 values from the four soils is used, the PECsoil-plateau is 506 µg/kg.
Če uporabimo geometrično povprečje vrednosti DT50 štirih prsti, je PKOzemlja-plato 506 µg/kg.
2.1.2 Soil adsorption and desorption
2.1.2 Adsorpcija in desorpcija v zemlji
Unisol 10% Oral solution
Unisol 10 % peroralna raztopina Peroralna raztopina
However, a margin of more than 800 between the estimated PECsw and the EC50 calculated on the basis of the data in the Robinson et al paper indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable.
Kljub temu meja več kot 800 med ocenjeno vrednostjo PKOsw in vrednostjo EC50, izračunano na podlagi podatkov iz prispevka Robinsona et al., kaže na zelo majhno izpostavljenost cianobakterijpri uporabi tega zdravila, ter zagotavlja, da je dejansko tveganje za cianobakterije sprejemljivo.
2.3.3 Fish Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Pimephales promelas (fathead minnow).
V študiji Robinsona et al. (2005)2 so proučili toksičnost enrofloksacina za Pimephales promelas (črnoglavega pisanca).
Using this PNEC value and the PECsoil established above (542.9 µg/kg) a risk quotient of 0.44 can be established for plants.
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOzemlja (542,9 µg/kg) se lahko za rastline določi količnik tveganja 0,44.
Please tell your doctor if:
Obvestite zdravnika, če:
Absolute Difference
Absolutna razlika
This leaflet was last revised in{month YYYY}.
Navodilo je bilo nazadnje revidirano dne{mesec LLLL}.
The interval between treatments will be decided by your doctor.
Interval med zdravljenji vam bo določil zdravnik.
Do not drive or use machinery until such effects have cleared.
Ne vozite in ne uporabljajte strojev, dokler ti učinki ne prenehajo.
Chemical and physical in-use stability has been demonstrated for 72 hours at 2 - 8°C.
Kemična in fizikalna stabilnost med uporabo je bila dokazana za 72 ur pri 2 °C-8 °C.
To prevent this, there must be a gap of at least three months between doses.
Da bi se to preprečilo, morajo med odmerki preteči najmanj trije meseci.
Following inactivation, dispose of in accordance with local requirements.
Po inaktivaciji jo zavrzite v skladu z lokalnimi zahtevami.
Symptomatic treatment should be instigated if necessary.
Po potrebi je treba začeti simptomatsko zdravljenje.
Effects on peri-/postnatal development have not been evaluated.
Učinki na razvoj v perinatalnem/postnatalem obdobju niso bili ocenjeni.
The central part of the rubber cap should be cleaned with alcohol.
Osrednji del gumijastega pokrovčka je treba očistiti z alkoholom.
- Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
- Zagotovite, da je injicirana količina/odmerek točen in po možnosti čim manjši.
- if you have an infection or inflammation at the proposed injection sites.
- če imate okužbo ali vnetje na predlaganih mestih injiciranja.
Each pack contains 1 vial.
Posamezno pakiranje vsebuje eno vialo.
Reconstitution should be performed in accordance with aseptic technique principles.
Rekonstitucijo je treba opraviti v skladu z načeli aseptične tehnike.
Swallowing and breathing difficulties are serious and can result in death.
Težave s požiranjem in dihanjem so resne in se lahko končajo s smrtjo.
Absorption, distribution, biotransformation and elimination (ADME) studies on the active substance have not been performed due to the nature of this product.
Študije absorpcije, porazdelitve, biotransformacije in izločanja (ADME) za učinkovino niso bile opravljene zaradi narave tega zdravila.
Reconstitution should be performed in accordance with good clinical practice, particularly with respect to aseptic technique.
Rekonstitucijo je treba opraviti v skladu z dobro klinično prakso, zlasti ob upoštevanju aseptične tehnike.
It works by blocking the nerve impulses to the muscles in which it has been injected.
Deluje z blokiranjem prenosa živčnih impulzov do mišic, v katere je bilo injicirano.
• Re-evaluation of the appropriateness of treatment with botulinum toxin type A. The efficacy and safety of repeat injections beyond 12 months has not been evaluated.
• ponovna ocena ustreznosti zdravljenja z botulinskim toksinom tipa A. Učinkovitost in varnost ponovnih injiciranj v obdobju, ki bi presegalo 12 mesecev, nista bili ocenjeni.
It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact.
Uporablja se pri odraslih, mlajših od 65 let, pri katerih imajo navedene obrazne gube pomemben psihološki vpliv.
Uncommon events occurred in between 2 and 7 subjects.
Občasni primeri so se pojavili pri dveh do sedmih osebah.
Number Percentage 4.2% 82.8% 87.2% 78.6% 83.1% 4.4%
Število Odstotek 4,2 % 82,8 % 87,2 % 78,6 % 83,1 % 4,4 % (% CI) P-vrednost Lestvica za glabelarne gube (GLS - Glabellar Lines Score); 0 = brez gub, 1 = blaga izraženost, 2 =
Only clear, colorless solution without particles should be used.
Uporabi se lahko samo bistra, brezbarvna raztopina brez delcev.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before you receive this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
4 Units
4 enote
The usual dose of NUCEIVA is 20 Units.
Običajni odmerek zdravila NUCEIVA je 20 enot.
Most side effects are of mild to moderate severity.
Večina neželenih učinkov je blagih do zmernih.
This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only.
Opomba: Od 1659 oseb, zdravljenih z zdravilom NUCEIVA, so se redki primeri pojavili pri samo eni osebi.
Signs of overdose may not be apparent immediately post-injection.
Znaki prevelikega odmerjanja se morda ne pokažejo takoj po injiciranju.
Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided.
Preprečiti je treba injiciranje v ranljive anatomske strukture, kot so živci in krvne žile.
These instructions for use, handling and disposal should be strictly followed.
Ta navodila za uporabo, rokovanje in odlaganje je treba dosledno upoštevati.