natgillin/translations-raw huggingface dataset:
Before administration of a Yttrium (90Y)-labelled medicinal product pregnancy has to be excluded.
Pred dajanjem z itrijem (90Y) označenega zdravila je potrebno izključiti nosečnost.
Alternative techniques which do not involve ionising radiation should always be considered.
Vedno je potrebno razmišljati o uporabi alternativnih tehnik, ki ne vključujejo ionizirajočega sevanja.
Before administering a radioactive medicinal product to a mother who is breast feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breastfeeding.
Pred dajanjem radiofarmaka doječi materi, je treba razmisliti ali je mogoče s preiskavo upravičeno odlašati, dokler mati ne preneha z dojenjem.
If the administration cannot be delayed, a lactating mother should be advised to stop breastfeeding.
Če dajanje radiofarmaka ne more biti odloženo, je treba doječi materi svetovati, naj preneha z dojenjem.
Further information concerning the use of a Yttrium (90Y)-labelled medicinal in pregnancy and lactation is specified in the Summary of Product Characteristics of the medicinal product to be radiolabelled.
Dodatne informacije, ki zadevajo uporabo z itrijem (90Y) označenega zdravila v času nosečnosti in dojenja, so podrobno opisane v povzetku glavnih značilnosti zdravila, ki bo radioaktivno označevano.
Effects on ability to drive and to use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelIed.
Vplivi na sposobnost vožnje in upravljanje s stroji po zdravljenju z zdravilom, označenim z itrijem (90Y), bodo natančno opisani v povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki bo radioaktivno označevano.
Possible side effects following the intravenous administration of Yttrium (90Y)-labelled a medicinal product prepared by radiolabelling with Yttriga, will be dependent on the specific medicinal product being used.
Morebitni neželeni učinki, ki so posledica intravenskega dajanja zdravila, označenega z itrijem (90Y) in pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga, bodo odvisni od specifičnega zdravila, ki bo uporabljeno.
Such information will be supplied in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Takšne informacije bodo zbrane v povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki bo radioaktivno označevano.
The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended therapeutic result.
Dana radioaktivnost mora biti najnižja možna ob upoštevanju dejstva, da je potrebno doseči nameravani rezultat zdravljenja.
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
V vseh primerih je potrebno zagotoviti, da so tveganja zaradi sevanja manjša od same bolezni.
The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga will lead to increased bone marrow toxicity and haematopoetic stern cell damage.
Prisotnost prostega itrijevega (90Y) klorida v telesu, po nenamernem dajanju zdravila Yttriga, bo povzročila povečano toksičnost za kostni mozeg in okvaro hematopoetskih matičnih celic.
Therefore, in case of an inadvertent administration of Yttriga, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like Ca- DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.
Zaradi tega je potrebno, v primeru nenamernega vnosa radiofarmacevtskega predhodnika Yttriga, radiotoksičnost za bolnika zmanjšati s takojšnjim (t. j. v roku 1 ure) dajanjem preparatov, ki vsebujejo kelatorje, kot sta Ca- DTPA ali Ca- EDTA, da se pospeši odstranjevanje radionuklidov iz telesa.
- Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or
- Ca- DTPA (trinatrijev kalcijev dietilentriamin pentaacetat) ali
- Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
- Ca- EDTA (kalcijev dinatrijev etilendiamin tetraacetat)
1 g of the chelating agents should be administered by slow intravenous injection over 3 – 4 minutes or by infusion (1 g in 100 – 250 ml of dextrose, or normal saline).
1 g kelatorja se daje s počasno intravensko injekcijo v času 3 – 4 minut ali z infuzijo (1 g v 100 – 250 ml dekstroze ali fiziološke raztopine).
In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
V vsakem primeru je potrebno opazovati bolnikove krvne parametre in takoj ustrezno ukrepati, če se pokažejo znaki okvare kostnega mozga.
{group}, ATC code:
{skupina}, oznaka ATC:
{code} [pending]
{oznaka} [v teku]
The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Farmakodinamične lastnosti z itrijem (90Y) označenega zdravila, pripravljenega z radioaktivnim označevanjem z radiofarmacevtskim predhodnikom Yttriga pred dajanjem, bodo odvisne od vrste zdravila, ki bo radioaktivno označevano.
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Upoštevajte povzetek glavnih značilnosti zdravila/ navodilo za uporabo določenega zdravila, ki bo radioaktivno označeno.
At 1 and 24 hours, blood radioactivity decreases from 11.0% to 0.14% of the administered activity.
Po 1 uri in 24 urah se radioaktivnost krvi zmanjša z 11, 0% na 0, 14% dane aktivnosti.
In the liver, 18% of the injected activity is taken up 5 min after injection.
Jetra 5 minut po injekciji sprejmejo 18% injicirane aktivnosti.
Liver uptake decreases then to 8.4% 24 hours after injection.
24 ur po dajanju se vrednost v jetrih zmanjša na 8, 4%.
In bone, percentage of injected activity increases from 3.1% at 5 min to 18% at 6 hours and then decreases with time.
V kosteh odstotek injicirane aktivnosti naraste s 3, 1%, po 5 minutah, na 18%, po 6 urah, in se nato sčasoma zmanjšuje.
Faecal and urinary elimination is slow: about 31% of the administered activity is eliminated in 15 days.
Izločanje z blatom in urinom je počasno: okrog 31% dane aktivnosti se izloči po 15 dneh.
Hydrochloric acid (0.04 M)
klorovodikova kislina (0, 04 M)
1t is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled medicinal product are thoroughly cleaned to ensure freedom from such trace metal impurities.
Pomembno je, da je vsa steklovina, igle za brizge itn., ki se uporabljajo za pripravo radioaktivno označenih zdravil, temeljito očiščena, tako da se zagotovi odsotnost takšnih nečistot.
6.4 Special precautions for storage
5 6. 4 Posebna navodila za shranjevanje
No special storage conditions required.
Ni posebnih pogojev za shranjevanje.
6.5 Nature and contents of container
6. 5 Vrsta in vsebina vsebnika
Colourless type I glass vial of 3 ml with a V-shapped bottom or a 10 ml with a flat bottom with a PTFE faced chlorobytylrubber stopper or silicon stopper, closed with an aluminium seal.
Brezbarvna steklena viala tip I, volumna 3 ml, z dnom v obliki črke V, ali volumna 10 ml, z ravnim dnom, z gumeno zaporko iz klorobutilnega kavčuka ali silikona usmerjeno proti PTFE, zaprto z aluminijastim pokrovčkom.
The outer container is a lead container lined with synthetic material inside.
Zunanji vsebnik je svinčen, na notranji strani prevlečen s sintetičnim materialom.
1 vial containing 0.02-5 ml solution calibrated for a reference day/ time depending on the ordered radioactivity.
1 viala vsebuje 0, 02- 5 ml raztopine, kalibrirane za referenčni dan/ uro, odvisno od naročene radioaktivnosti.
nuclitec GmbH Gieselweg 1 D-38110 Braunschweig Germany
nuclitec GmbH Gieselweg 1 D- 38110 Braunschweig Nemčija
Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Informacije o dozimetriji sevanja vsakega različnega zdravila po dajanju radioaktivno označenega zdravila, bodo na voljo v povzetku glavnih značilnosti zdravila/ navodilu za uporabo določenega zdravila, ki bo radioaktivno označevano.
6 The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of Yttriga.
Spodnja tabela dozimetrije predstavlja ocenjevanje prispevka nekonjugiranega itrija (90Y) k prejeti dozi sevanja, ki sledi dajanju z itrijem (90Y) označenega zdravila ali kot rezultat radioaktivno označene naključne intravenske injekcije radiofarmacevtskega predhodnika Yttriga.
The dosimetry estimates were based on a rat distribution study and the calculations were effected in accordance with MIRD/ ICRP 60 recommendations.
Dozimetrične ocene temeljijo na študiji porazdelitve pri podganah, izračuni pa so bili izvedeni v skladu s priporočili MIRD/ ICRP 60.
Absorbed dose per unit activity administered (mGy/ MBq)
6 Absorbirana doza na enoto dane aktivnosti (mGy/ MBq)
10 years 5 years 1 year
10 let 5 let 1 leto
5 years 10 years 5 years
5 let 10 let 5 let
Newborn
Novorojenč
(5 kg)
ki (5 kg)
Adrenals Blood Bone marrow Brain Carcass Colon Femur Gastro-intestinal
nadledvična žleza kri kostni mozek možgani okostje kolon femur vsebina
7.23 E-01 4.20 E-02 2.58 E+00 8.60 E-03 5.82 E-01 2.30 E-02 7.76 E+00
7. 23 E- 01 4. 20 E- 02 2, 58 E+00 8. 60 E- 03 5, 82 E- 01 2, 30 E- 02 7, 76 E+00
1.09 E+00 6.29 E-02 3.88 E+00 1.29 E-02 8.72 E-01 3.46 E-02 1.16 E+01
1. 09 E+00 6, 29 E- 02 3, 88 E+00 1, 29 E- 02 8, 72 E- 01 3, 46 E- 02 1, 16 E+01
2.53 E+00 1.47 E-01 9.05 E+00 3.01 E-02 2.04 E+00 8.06 E-02 2.72 E+01
2. 53 E+00 1, 47 E- 01 9, 05 E+00 3, 01 E- 02 2, 04 E+00 8, 06 E- 02 2, 72 E+01
2.17 E+01 1.26 E+00 7.75 E+01 2.58 E-01 1.75 E+01 6.91 E-01 2.33 E+02
2. 17 E+01 1, 26 E+00 7, 75 E+01 2, 58 E- 01 1, 75 E+01 6, 91 E- 01 2. 33 E+02
content Heart Ileum Kidneys Liver Lungs Ovaries Pancreas Skeletal muscle Skin Spleen Stomach Thymus Thyroids Urinary bladder Uterus Effective Dose
srce ileum ledvice jetra pljuča ovariji pankreas skeletne mišice koža vranica želodec timus žleza ščitica mehur uterus učinkovit
1.22 E-01 2.53 E-01 1.16 E-02 2.35 E+00 1.27 E+00 4.23 E-01 3.33 E-01 7.90 E-02 6.12 E-04 1.02 E-01 4.90 E-01 6.47 E-02 7.34 E-02 9.99 E-01 3.62 E-01 1.51 E-02
2, 53 E- 01 1, 16 E- 02 2, 35 E+00 1, 27 E+00 4, 23 E- 01 3, 33 E- 01 7, 90 E- 02 6. 12 E- 04 1, 02 E- 01 4, 90 E- 01 6, 47 E- 02 7, 34 E- 02 9, 99 E- 01 3, 62 E- 01 1, 51 E- 02
1.22 E+00 2.53 E+00 1.16 E-01 2.35 E+01 1.27 E+01 4.23 E+00 3.33 E+00 7.90 E-01 6.12 E-03 1.02 E+00 4.90 E+00 6.47 E-01 7.34 E-01 9.99 E+00 3.62 E+00 1.51 E-01
2. 53 E+00 1, 16 E- 01 2, 35 E+01 1, 27 E+01 4, 23 E+00 3, 33 E+00 7, 90 E- 01 6, 12 E- 03 1, 02 E+00 4, 90 E+00 6, 47 E- 01 7, 34 E- 01 9, 99 E+00 3, 62 E+00 1, 51 E- 01
(mSv/ MBq)
odmerek (mSv/ MBq)
1.99 E+1
1. 99 E+1
7 The vial should never be opened and must be kept inside its lead shielding.
Viale se ne sme nikoli odpreti, ostati mora znotraj svinčene zaščite.
9 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
nuclitec GmbH Gieselweg 1 38110 Braunschweig Germany
nuclitec GmbH Gieselweg 1 38110 Braunschweig Nemčija
TIN CAN AND LEAD POT
PLOČEVINKA IN SVINČENA POSODA
Yttrium (90Y) chloride
Yttriga radiofarmacevtski predhodnik, raztopina itrijev (90Y) klorid
(Y) GBq/ vial
(Y) GBq/ viala
{DD/ MM/ YYYY} (12h CET)
{DD/ MM/ LLLL} (12h CET)
Specific activity at calibration:
Specifična aktivnost pri kalibraciji:
EXP {MM/ YYYY} (12h CET)
EXP {DD/ MM/ LLLL} (12h CET)
Batch N°:
Št. serije:
EXP {DD/ MM/ YYYY} (12h CET)
EXP {DD/ MM/ LLLL} (12h CET)
{Y}________GBq/ vial
{Y} ________ GBq/ vial
{DD/ MM/ AAAA} (12h CET)
{DD/ MM/ LLLL} (12h CET)
Yttriga Yttrium (90Y) chloride solution for in-vitro labelling
Yttriga raztopina itrijevega (90Y) klorida za označevanje in- vitro
Yttrium (90Y) Chloride
Yttriga radiofarmacevtski predhodnik, raztopina. itrijev (90Y) klorid
What Yttriga is and what it is used for 2.
Kaj je radiofarmacevtski predhodnik Yttriga in za kaj ga uporabljamo 2.
Before you use Yttriga 3.
Kaj morate vedeti, preden boste uporabili radiofarmacevtski predhodnik Yttriga 3.
4.
Kako uporabljati radiofarmacevtski predhodnik Yttriga 4.
How to store Yttriga 6.
Shranjevanje radiofarmacevtski predhodnik Yttriga 6.
The active substance is Yttrium (90Y) Chloride.
Zdravilna učinkovina je itrijev (90Y) klorid.
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
1 ml sterilne raztopine vsebuje 0, 1- 300 GBq itrija (90Y), ob referenčnem datumu in času (ustrezna 0, 005- 15 mikrogramom itrija [90Y]) (kot itrijev [90Y] klorid).
Each vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Vsaka viala vsebuje 0. 1- 300 GBq, ustrezno z 0. 005- 15 mikrogrami itrija (90Y) ob referenčnem datumu in času.
1 vial contains 0.02 -5 ml sterile Yttrium (90Y) solution (as Yttrium [90Y] chloride).
1 viala vsebuje 0. 02 - 5 ml sterilne raztopine itrija (90Y) (kot itrijev [90Y] klorid).
Yttriga is a radiopharmaceutical precursor which is a clear and colourless solution.
Yttriga je radiofarmacevtski predhodnik, ki je bistra, brezbarvna raztopina.
It comes in single vials containing 0.1-300 GBq (corresponding to 0.005-15 micrograms of (90Y) Yttrium calibrated at 12h00 at calibration date.
Na voljo je v posameznih vialah, ki vsebujejo 0, 1- 300 GBq (kar ustreza 0, 005- 1, 5 mikrogramom itrija (90Y), kalibriranega ob 12h00 na kalibracijski datum.
For further information regarding the treatment and possible effects caused by the medicinal product to be radiolabelled, please refer to the package leaflet of the medicinal product to be radiolabelled.
Za dodatne informacije o zdravljenju in morebitnih učinkih, ki jih povzroča zdravilo, ki bo radioaktivno označevano, upoštevajte navodilo za uporabo zdravila, ki bo radioaktivno označevano.
- if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of
če ste alergični na (preobčutljivi za) itrijev (90Y) klorid ali katerokoli sestavino
Yttriga.
radiofarmacevtskega predhodnika Yttriga.
- if you are pregnant or if there is a possibility that you may be pregnant (see below).
- če ste noseči ali obstaja možnost, da ste morda noseči (glejte spodaj).
Take special care with Yttriga
Bodite posebno pozorni pri uporabi radiofarmacevtski predhodnik Yttriga
Radiopharmaceutical precursor - Not intended for direct use in patients
Radiofarmacevtski predhodnik – Ni namenjen za direktno uporabo na bolnikih
It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Z njim naj ravnajo in
18 Particular care should be taken when administering radioactive medicinal products to children and adolescents.
18 ga uporabljajo samo osebe, ki so usposobljene in kvalificirane za varno ravnanje z radioaktivnimi materiali.
Taking other medicines Please inform your doctor or pharmacist, if you are taking or have recently taken any other medicines, even those not prescribed.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
No interaction of Yttrium (90Y) chloride with other medicinal products are known, because no studies have investigated this issue.
Medsebojno delovanje itrijevega (90Y) klorida z drugimi zdravili ni poznano, ker študij niso izvedli.
Using Yttriga with food and drink No special care is needed.
Uporaba radiofarmacevtskega predhodnika Yttriga skupaj s hrano in pijačo Posebna previdnost ni potrebna.
It is important to tell your doctor if there is any possibility that you are pregnant.
Pomembno je, da svojemu zdravniku sporočite, če obstaja možnost, da ste noseči.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Pri vsaki ženski, kateri je izostalo mesečno perilo, je treba predpostavljati, da je noseča, dokler ni dokazano nasprotno.
Alternative techniques which do not involve ionising radiation should always be considered.
Vedno je treba razmišljati o uporabi alternativnih tehnik, ki ne vključujejo ionizirajočega sevanja.
Yttriga is not be administered directly to the patient.
Radiofarmacevtskega predhodnika Yttriga se ne sme dajati direktno bolniku.
Dosage Your physician will decide on the amount of Yttriga to be used in your case.
Odmerek Zdravnik bo določil količino radiofarmacevtski predhodnik Yttriga, ki bo uporabljena v vašem primeru.
Method of administration Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Radioaktivno označena zdravila se nato daje v skladu z odobreno potjo uporabe.
If Yttriga is administered inadvertently Since Yttriga is administered by a doctor under strictly controlled conditions there is little risk of possible overdose.
Če ste radiofarmacevtski predhodnik Yttriga dali pomotoma Ker radiofarmacevtski predhodnik Yttriga daje samo zdravnik pod strogo nadzorovanimi pogoji, obstaja majhno tveganje za morebiten prevelik odmerek.
However, should this occur, you will receive appropriate treatment from your doctor.
Če se to vseeno zgodi, vam bo zdravnik nudil primerno zdravljenje.
Store in accordance with local regulations for radioactive substances.
19 Shranjujte v skladu z lokalnimi predpisi za radioaktivne snovi.
Do not use Yttriga after the expiry date and time which is stated on the label.
Radiofarmacevtskega predhodnika Yttriga ne smete uporabljati po datumu in uri izteka roka uporabnosti, ki sta navedena na ovojnini.
What Yttriga contains
Kaj vsebuje radiofarmacevtski predhodnik Yttriga
- The other ingredient is hydrochloric acid (0.04 M).
- Pomožna snov je klorovodikova kislina (0, 04 M).
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
1 ml sterilne raztopine vsebuje 0, 1- 300 GBq itrija (90Y) ob referenčnem datumu in času (ustreza 0, 005- 15 mikrogramom itrija [90Y]) (kot itrijev [90Y] klorid).
Each vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Vsaka viala vsebuje 0, 1- 300 GBq, kar ustreza 0, 005- 15 mikrogramom itrija (90Y) ob referenčnem datumu in času.
The theoretical specific activity is 20 GBq/ micrograms of Yttrium (90Y)
Teoretična specifična aktivnost je 20 GBq/ mikrogram itrija (90Y).
nuclitec GmbH Gieselweg 1, D-38110 Braunschweig Germany Tel +49- 05307-932262 Fax +49- 05307-932337 e-mail
nuclitec GmbH Gieselweg 1, D- 38110 Braunschweig Nemčija Tel +49 - 05307- 932262 Faks +49 - 05307- 932337 e- pošta:
It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘ orodispersible’ tablets (5, 7.5, 10, 15 and 20 mg).
Na voljo je v obliki okroglih rumenih tablet (2, 5 mg, 5 mg, 7, 5 mg, 10 mg, 15 mg in 20 mg) in okroglih rumenih „ orodisperzibilnih “ tablet (5 mg, 7, 5 mg, 10 mg, 15 mg in 20 mg).
Zalasta is a ‘ generic medicine’.
Zdravilo Zalasta je „ generično zdravilo “.
This means that Zalasta is similar to ‘ reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
To pomeni, da je podobno „ referenčnima zdraviloma “, ki sta že odobreni v Evropski uniji (EU), in sicer zdravilu Zyprexa in zdravilu Zyprexa Velotab.
10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Priporočeni začetni odmerek zdravila Zalasta je odvisen od bolezni, ki jo zdravimo: odmerek 10 mg na dan se uporablja pri shizofreniji in za preprečevanje maničnih epizod, odmerek 15 mg na dan pa se uporablja pri zdravljenju maničnih epizod, razen v primeru sočasne uporabe z drugimi zdravili, ko lahko začetni odmerek znaša 10 mg na dan.
Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Zdravilna učinkovina zdravila Zalasta, olanzapin, je antipsihotično zdravilo.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Spada med „ atipične “ antipsihotike, ker se razlikuje od starejših antipsihotikov, ki so na voljo že od petdesetih let minulega stoletja.
Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i. e. that the medicines produce the same levels of the active substance in the body).
Ker je zdravilo Zalasta generično zdravilo, so bile študije omejene na teste, s katerimi se lahko dokaže, da je bioekvivalentno referenčnima zdraviloma (to pomeni, da omenjena zdravila dosegajo enake ravni zdravilne učinkovine v telesu).
Therefore, the CHMP’ s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da koristi zdravila Zalasta tako kot pri zdravilih Zyprexa in Zyprexa Velotab odtehtajo znana tveganja.
The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d. d., Novo mesto on 27 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Zalasta, veljavno po vsej Evropski uniji, odobrila družbi KRKA, d. d., Novo mesto dne 27. septembra 2007.
Zalasta 2.5 mg tablets
Zalasta 2, 5 mg tablete
Each tablet contains 2.5 mg olanzapine.
1 tableta vsebuje 2, 5 mg olanzapina.
Each tablet contains 40.4 mg lactose.
Pomož snov: na 1 tableta vsebuje 40, 4 mg laktoze.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Tablete so okrogle, rahlo izboč svetlo rumene barve z morebitnimi posameznimi rumenimi ene, pikami.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapin je uč inkovit za vzdrž evanje kliničnega izboljš pri nadaljevanju zdravljenja bolnikov, pri anja katerih je priš do zač
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Olanzapin je indiciran za zdravljenje zmerne do hude manič epizode. ne
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
Pri bolnikih z manič epizodo bipolarne motnje, ki so pokazali odziv na zdravljenje z olanzapinom, no je olanzapin indiciran za prepreč evanje ponovnega pojava bolezni (gl. poglavje 5. 1).
The recommended starting dose for olanzapine is 10 mg/ day.
Odrasli Shizofrenija Priporoč zač odmerek olanzapina je 10 mg na dan. eni etni
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Manič epizoda na Zač odmerek je 15 mg v enkratnem dnevnem odmerku pri monoterapiji ali 10 mg na dan pri etni kombiniranem zdravljenju (gl. poglavje 5. 1).
Preventing recurrence in bipolar disorder:
Prepreč evanje ponovnega pojava bolezni pri bipolarni motnji Priporoč zač odmerek je 10 mg na dan.
The recommended starting dose is 10 mg/ day.
Pri bolnikih, ki so jemali olanzapin za zdravljenje
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
manič epizode, nadaljujte zdravljenje z enakim odmerkom olanzapina za prepreč