natgillin/translations-raw huggingface dataset:
You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with hydroxycarbamide.
Med zdravljenjem in po prenehanju zdravljenja s hidroksikarbamidom si morate kožo zaščititi pred soncem in si jo redno pregledovati.
Infections and infestations
Preiskave in pregledi
To minimise air bubbles, the bottle should not be shaken prior to dosing.
Pred dajanjem odmerka ne pretresite steklenice, da čim bolj omejite nastanek zračnih mehurčkov.
o Teratogenicity and male fertility; Need for contraception; Breast feeding; o Growth follow-up in children; - Key signs and symptoms of serious adverse reactions; - Information on crisis or infections; When to seek urgent attention from the health care provider
o okvara ledvic in/ali jeter, o teratogenost in plodnost moških, potreba po kontracepciji, dojenje, o spremljanje rasti otrok;
You should not take Xromi if you have severe kidney disease.
Če imate hudo ledvično okvaro, ne smete jemati zdravila Xromi.
Leg ulcers
Ulysses House
Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Pri bolnikih z mieloproliferativnimi motnjami so se med zdravljenjem s hidroksikarbamidom pojavili toksični kožni vaskulitisi, vključno z vaskulitičnimi ulkusi in gangreno.
Elevated liver enzymes, Hepatotoxicity
Bolezni jeter, žolčnika in žolčevodov občasni zvišane vrednosti jetrnih encimov, hepatotoksičnost
Put on disposable hand gloves before handling Xromi.
Pred rokovanjem z zdravilom Xromi nataknite rokavice za enkratno uporabo.
The Guide for healthcare professionals shall contain the following key elements: - Indication, dosage and dose adjustment; - Description of safe handling of Xromi, including the risk of medication error due to the use of two different dosing syringes; - Warnings about important risks associated with using Xromi: o Switching patients from capsule and tablet to liquid formulation; o Haematological toxicity, use of other myelosuppressive agent or radiation therapy; o Concomitant use of nucleoside analogue reverse transcriptase inhibitors; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer); o Teratogenicity and male fertility; Need for contraception; Breast feeding; o Adverse drug reactions most frequently reported; - Follow-up of patients treated with Xromi: o Haematological follow-up and dose adjustment; o Follow-up of patients with renal and/or hepatic impairment; o Growth follow-up in children;
o prehod bolnikov s kapsul in tablet na tekočo obliko zdravila, o hematološka toksičnost, uporaba drugih mielosupresivnih zdravil ali radioterapije, o sočasna uporaba analogov nukleozidnih zaviralcev reverzne transkriptaze, o kožni ulkusi in vaskulitis, ulkusi na nogah,
In all clinical studies, there was a significant increase in
Pri vseh kliničnih študijah so po uporabi hidroksikarbamida opazili znaten porast HbF v primerjavi z izhodiščem.
Hydroxycarbamide can cause foetal harm when administered to a pregnant woman.
Če se hidroksikarbamid da nosečnici, lahko škoduje plodu.
Adverse reactions affecting the skin and subcutaneous tissue such as darkening of the skin nail beds, dry skin, skin ulcers, and alopecia tend to occur following several years of long-term daily maintenance therapy.
kožni ulkusi in alopecija, se običajno pojavijo po več letih dolgotrajne vsakodnevne vzdrževalne terapije.
Hydroxycarbamide is an orally active antineoplastic agent.
Mehanizem delovanja Hidroksikarbamid je peroralno aktivno zdravilo z delovanjem na novotvorbe.
Oligospermia, azoospermia
Motnje reprodukcije in dojk zelo pogosti oligospermija, azoospermija neznana amenoreja
- if you have a liver disease (additional monitoring may be needed) - if you have a kidney disease (the dose may be adjusted) - if you have leg ulcers - if you have a known lack of vitamin B12 or folate
- če imate ulkuse na nogah, - če imate znano pomanjkanje vitamina B12 ali folatov.
Full blood cell count with white cell differential and reticulocyte count should be monitored every 2 weeks for the first 2 months following treatment initiation.
Prva dva meseca po začetku zdravljenja je treba število vseh krvnih celic, vključno z diferencialno belo krvno sliko in številom retikulocitov,
Gastrointestinal disturbances, gastrointestinal ulcer, severe hypomagnesaemia
Bolezni prebavil pogosti navzea, zaprtost občasni stomatitis, driska, bruhanje neznana prebavne motnje, gastrointestinalna razjeda, huda hipomagneziemija
Posology
Razpon
Range
SERIJ
Hydroxycarbamide administered to male rats at 60 mg/kg body weight/day (about double the recommended usual maximum dose in humans) produced testicular atrophy, decreased spermatogenesis and significantly reduced their ability to impregnate females.
(približno dvakratni odmerek priporočenega najvišjega odmerka za človeka), je povzročil atrofijo mod, zmanjšanje spermatogeneze in bistveno zmanjšano sposobnost za oploditev samic.
Mean corpuscular haemoglobin concentration (MCHC) (%)
Povprečna koncentracija neznačilna hemoglobina v eritrocitu (MCHC)
- if you take antiretroviral medicines for the treatment of Human Immunodeficiency Virus (HIV),
- če ste noseči ali dojite (glejte poglavje „Nosečnost, dojenje in plodnost“), - če jemljete protiretrovirusna zdravila za zdravljenje virusa humane imunske pomanjkljivosti
Stomatitis, diarrhoea, vomiting
Bolezni živčevja pogosti glavobol, omotica
Platelets (×109/L)
Trombociti (× 109/l) 443,2 ± 189,1
- Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov - vnetje kože, ki povzroča nastajanje rdečih, luskastih zaplat in se lahko pojavlja skupaj z bolečinami v sklepih
Speak to your doctor if you are concerned by any of these side effects.
Če ste zaskrbljeni zaradi katerega od teh neželenih učinkov, se posvetujte z zdravnikom.
After 18 months of treatment, there was a significant difference in the number of vaso-occlusive crises between the hydroxycarbamide group and placebo group, mean difference
P-vrednost je za primerjavo med skupinama s hidroksikarbamidom oziroma placebom pri 18 mesecih.
Reproductive system and breast disorders
Ženske v rodni dobi/kontracepcija pri moških in ženskah
In a randomised, double-blind, placebo controlled study conducted in a tertiary hospital in India,
V randomizirani, dvojno slepi, s placebom kontrolirani študiji v terciarni bolnišnici v Indiji so 60 otrok (starih 5-18 let), ki so na leto imeli tri ali več transfuzije krvi ali vazookluzivne krize,
Package leaflet: Information for the user Xromi 100 mg/ml oral solution hydroxycarbamide Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Intravenous administration should not be protracted over more than 2 hours.
Z intravenskim dajanjem se ne sme odlašati več kot dve uri.
The use of television monitor systems to monitor the patients is recommended.
Priporočljiva je uporaba sistemov s televizijskim monitorjem za spremljanje bolnikov.
ICRP-30 data
Podatki ICRP-30
Email: quality@idb-radiopharmacy.com
E-pošta: quality@idb-radiopharmacy.com
The ART is defined as the end of production.
ART je določen kot konec izdelave.
Precautions with respect to relatives, carers and hospital staff are provided in section 6.6.
Previdnostni ukrepi, namenjeni sorodnikom, negovalcem in bolnišničnemu osebju, so navedeni v poglavju 6.6.
Effects of the respiration were slight and variable.
Učinki na dihanje so bili rahli in spremenljivi.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1013/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/15/1013/001
(GBq: GigaBecquerel is the unit in which radioactivity is measured).
(GBq: gigabekerel je enota za merjenje radioaktivnosti).
However, in case of an overdose, you will receive the appropriate treatment.
Če kljub temu pride do prevelikega odmerjanja, boste prejeli ustrezno zdravljenje.
Also low gamma energy is emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Prav tako prihaja do emisije nizkoenergijskih gama žarkov, npr. 113 keV (6,2 %) in 208 keV (11 %).
No gross differentiating changes were found of the tissues demonstrating no evidence of acute damage resulting from the experiment.
V tkivih niso odkrili večjih diferencialnih sprememb, zato niso našli dokazov o akutnih poškodbah, ki bi nastale zaradi eksperimenta.
This is below the threshold considered acceptable for discharge from the clinic (20 µSv/h).
Ta stopnja je pod pragom, ki ga upoštevamo za sprejemljivega za odpust s klinike (20 µSv/h).
Activity measurements using an ionization chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Meritve aktivnosti z uporabo ionizacijske celice so zelo občutljive na geometrične faktorje in jih je zaradi tega treba izvajati samo pod geometričnimi pogoji, ki so bili primerno validirani.
It appeared that more than 78% of the doses was distributed into liver, bone and spleen.
Ugotovili so, da se je več kot 78 % odmerkov porazdelilo v jetra, kosti in vranico.
Client code:
Šifra stranke:
For minimising radiation exposure resulting from repeated exposure, there is no specific recommendation except the strict observance of the above ones.
Za zmanjšanje izpostavljenosti sevanju, do katere prihaja ob ponavljajoči se izpostavljenosti, ni specifičnih priporočil, z izjemo strogega upoštevanja zgoraj navedenih.
However, a post-exposure interval >1 hour does not preclude the administration and effective action of chelator with reduced efficiency.
Kljub temu pa interval > 1 ure po izpostavljenosti ne izključuje dajanja in uspešnega delovanja kelatorja z zmanjšano učinkovitostjo.
Fax: +31(0)13 5079 912
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Electrocardiograms showed no irregularities in cardiac rhythm or conduction.
Elektrokardiogrami niso pokazali nepravilnosti v srčnem ritmu ali prevodnosti.
Do not use this medicine after the expiry date and time which are stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu in času izteka roka uporabnosti, ki sta navedena na nalepki poleg oznake EXP.
With respect to the distribution pattern in blood it appeared that 2 h after administration 15% of the Lutetium as being present in blood, had entered the blood cells with the remaining 85% still being present in the serum.
Glede na vzorec porazdelitve v krvi, so ugotovili, da je dve uri po dajanju 15 % lutecija, ki je bil prisoten v krvi, vstopilo v krvne celice, preostalih 85 % pa je bilo še vedno prisotnih v serumu.
8 days from the date of ART (= end of production).
6.3 Rok uporabnosti 8 dni od datuma ART (= konec izdelave).
No special storage condition required.
Ni posebnih pogojev za shranjevanje.
The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Učinkovitost keliranja je največja takoj ali eno uro po izpostavljenosti, ko radionuklid kroži ali se nahaja v tkivnih tekočinah in plazmi.
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 treba zagotoviti, da so tveganja zaradi sevanja manjša od tveganj bolezni same.
These medicines can then be used in medical procedures to carry radioactivity to where it is needed in the body such as sites of tumour cells.
Ta zdravila je nato mogoče uporabiti v medicinskih postopkih za prenašanje radioaktivnosti v tiste dele telesa, kjer jo potrebujemo, npr. na mesta tumorskih celic.
It will only be administered as a combination.
Dan bo le v kombinaciji.
The European Medicines Agency has waived the obligation to submit the results of the studies with Lumark in all subsets of the paediatric population on grounds that the specific medicinal product is likely to be ineffective or unsafe in part or all of the paediatric population and on grounds that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for the paediatric patients.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z radionuklidnim predhodnikom Lumark za vse podskupine pediatrične populacije na podlagi dejstva, da določeno zdravilo verjetno ni učinkovito ali varno za del ali za celotno pediatrično populacijo in na podlagi dejstva, da določeno zdravilo v okviru obstoječih zdravljenj ne kaže posebne terapevtske koristi za pediatrične bolnike.
This should be taken into account when considering the benefit/risk, especially in patients with possible risk factors like prior exposure to chemotherapeutic agents (such as alkylating agents).
To je treba upoštevati pri ocenjevanju razmerja med koristjo in tveganjem, zlasti pri bolnikih z možnimi dejavniki tveganja, kot je predhodna izpostavitev kemoterapevtskim učinkovinam (npr. alkilirajočim citostatikom).
The surface dose rates and the accumulated dose depend on many factors.
Stopnje površinskega odmerka in kopičenega odmerka so odvisne od več dejavnikov.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti radionuklidnega predhodnika za ta radionuklidni predhodnik predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
- Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
- Ugotovljena nosečnost ali sum nanjo ali kadar nosečnost ni bila izključena (glejte poglavje 4.6).
Absorbed dose per unit activity administered for various tissues
Absorbirani odmerek na enoto dane aktivnosti za različna tkiva
These people will take special care for the safe use of this product and will keep you informed of their actions.
Te osebe bodo posebej pozorne na varno uporabo radionuklidnega predhodnika in vas bodo sproti obveščale o svojem ravnanju.
Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff.
Meritve na lokaciji in med delom so ključnega pomena in jih je treba izvajati za natančnejšo in svetovalno določitev skupnega odmerka sevanja za osebje.
If at any time in the preparation of this product the integrity of this container is compromised it should not be used.
Če je kadar koli med pripravo tega radionuklidnega predhodnika ogrožena integriteta tega vsebnika,
Children and adolescents Medicines radiolabelled with Lumark should not be used in children and adolescents below 18 years of age.
Zdravila, radiooznačena z radionuklidnim predhodnikom Lumark, se ne smejo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.
To bo najmanjša količina, potrebna za doseganje ustreznega izida, glede na sočasno dano zdravilo in njegovo predvideno uporabo.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Client code:
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Koda stranke:
The vial should never be opened and must be kept inside its lead shielding.
Viala se ne sme nikoli odpreti, temveč mora ostati znotraj svinčene zaščite.
For a person in the vicinity of the patient, assuming continuous exposure at 2 m and infinite biological half-life (no disposal by the patient after discharge from the hospital), this dose rate will result in an overall dose of approximately 0.6 mSv, which is approximately one half of the dose limit set for general public (1 mSv/year).
Za osebo v bližini bolnika, kjer predvidevamo neprekinjeno izpostavljenost pri dveh metrih razdalje in neskončen biološki razpolovni čas (brez oddajanja sevanja bolnika po odpustu iz bolnišnice), bo ta stopnja odmerka povzročila celokupni odmerek približno 0,6 mSv, kar je približno polovica zgornje meje odmerka, določene za prebivalstvo (1 mSv/leto).
The distribution and mineral concentrations in the organs were investigated at low (9-10 mg/kg) and high (19-20 mg/kg) doses administered intravenously to rats.
Porazdelitev in mineralne koncentracije v organih so proučevali pri nizkih (9-10 mg/kg) in visokih (19-20 mg/kg) odmerkih, ki so jih podganam dali intravensko.
Appropriate aseptic precautions should be taken, in order to maintain the sterility of Lumark and to maintain sterility throughout the labelling procedures.
Poskrbeti je treba za primerne aseptične previdnostne ukrepe, da se ohrani sterilnost radionuklidnega predhodnika Lumark in sterilnost med postopki označevanja.
Lumark is a type of product called a radiopharmaceutical precursor.
Lumark je vrsta izdelka, ki ga imenujemo radionuklidni predhodnik.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
The dosimetry estimates are based on biodistribution data provided by ICRP-30, showing bone, liver and kidneys as the significant target organs for the biodistribution of lutetium.
Dozimetrične ocene temeljijo na podatkih o biološki porazdelitvi v skladu s priporočili ICRP-30 in prikazujejo kosti, jetra in ledvice kot bistvene ciljne organe za biološko porazdelitev lutecija.
Intravenously administrated doses resulted in varying effects on the blood pressure and a decreased heart rate.
Intravensko dani odmerki so povzročili različne učinke na krvni tlak in upočasnili srčni utrip.
Because Lutetium (177Lu) can sometimes affect your blood cells, your doctor will do blood tests before you start and at regular intervals during treatment.
Lutecij (177Lu) lahko včasih vpliva na vaše krvne celice, zato bo zdravnik pred zdravljenjem in v rednih intervalih med njim opravljal krvne preiskave.
This waiver does however not extend to any diagnostic or therapeutic uses of the product when linked to a carrier molecule (see section 4.2 for information on paediatric use).
Ta odstop od zahteve pa se ne nanaša na nobeno diagnostično ali terapevtsko uporabo radionuklidnega predhodnika, ki je vezana na nosilno molekulo (glejte poglavje 4.2 za informacije o pediatrični uporabi).
Relevant data is included in the Summary of Product Characteristics of the labeled medicinal products.
Ustrezni podatki so vključeni v povzetek glavnih značilnosti zdravila za označena zdravila.
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 glucose, or sodium chloride 9 mg/mL (0,9%) solution for injection).
1 g kelatorja se daje s počasnim intravenskim injiciranjem v času 3-4 minut ali z infuzijo (1 g v 100-250 ml glukoze ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje).
Dose / Injected Activity (mGy/MBq)
Odmerek/injicirana aktivnost (mGy/MBq)
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Če obstaja dvom glede nosečnosti (če je ženski izostala menstruacija, če je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi alternativne tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
Lumark is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Radionuklidni predhodnik Lumark se ne sme dajati neposredno bolniku, temveč ga je treba uporabiti za radioaktivno označevanje nosilnih molekul, kot so monoklonska protitelesa, peptidi ali drugi substrati.
For Lutetium (177Lu) the different dose levels did not result in significantly different uptake with 65% appearing in the liver, 5.3% in the spleen and 13% in the bones at one day after administration.
Pri luteciju (177Lu) različne ravni odmerkov niso povzročile bistveno različnega privzema, saj so ga v enem dnevu po dajanju odkrili 65 % v jetrih, 5,3 % v vranici in 13 % v kosteh.
Given the long half-life of Lutetium (177Lu) it is specially recommended to avoid internal contamination.
Glede na dolg razpolovni čas lutecija (177Lu) je še posebej priporočljivo, da se izognete notranji kontaminaciji.
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljen radionuklidni predhodnik ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official authorities.
Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja pristojnih organov.
When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Kadar se načrtuje dajanje radiofarmakov ženski v rodni dobi, je pomembno ugotoviti, ali je ženska morda noseča.
No animal toxicity studies were conducted with Lumark.
Študij toksičnosti na živali z radionuklidnim predhodnikom Lumark niso izvedli.
In the absence of compatibility studies, this medicinal product must not be mixed with medicinal products other than the medicinal products to be radiolabelled.
Zaradi pomanjkanja študij kompatibilnosti tega radionuklidnega predhodnika ne smemo mešati z drugimi zdravili, razen z zdravili, namenjenimi za radioaktivno označevanje.
It is not known whether Lutetium (177Lu) chloride may interact with other medicines as specific studies have not been carried out.
Ni znano, ali lahko lutecijev (177Lu) klorid vpliva na druga zdravila, saj specifičnih študij niso izvedli.
Before administration of Lumark you should: drink plenty of water before being given the radiolabelled medicine in order to urinate as often as possible during the first few hours after the procedure.
- pijte veliko vode, preden vam dajo radiooznačeno zdravilo, da boste v prvih urah po postopku čim pogosteje urinirali.
Lu)-chloride.
(177Lu) klorid.
Lutetium (177Lu) has a half-life of 6.647 days.
Lutecij (177Lu) ima razpolovno dobo 6,647 dneva.
The minimal specific activity is 500 GBq/mg Lutetium (177Lu) at the ART.
Minimalna specifična aktivnost je 500 GBq/mg lutecija (177Lu) v ART.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o radionuklidnem predhodniku so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
According to literature reports and taking a conservative approach (maximum patient dose of 10 GBq, average labeling yield and no additional measures), it may be considered that 177Lu-labelled medicinal products do not lead to reproductive toxicity including spermatogenetic damage in male testes or genetic damage in male testes or female ovaries.
Upoštevajoč poročila iz literature in konzervativni pristop (največji odmerek za bolnika 10 GBq, povprečen rezultat označevanja in odsotnost dodatnih ukrepov), lahko predpostavljamo, da z lutecijem (177Lu) označena zdravila ne vplivajo na sposobnost razmnoževanja, vključno z okvarami spermatogeneze v moških testisih in genetskimi okvarami moških testisov ali ženskih jajčnikov.
Intraperitoneal administration resulted in generalized peritonitis with adhesion and accumulation of some ascetic fluid.
Intraperitonealno dajanje je povzročilo generalizirani peritonitis z adhezijo in kopičenjem ascitesa.
• Carcinoid crisis
Neznana: karcinoidna kriza
Due to the capacity of the chelating ligands (DTPA, EDTA) of forming water soluble complexes, the complexes and bound Lutetium(177Lu) are rapidly eliminated by the kidneys.
Na podlagi zmožnosti kelatnih ligandov (DTPA, EDTA), da tvorijo v vodi topne komplekse, se kompleksi in vezani lutecij (177Lu) hitro izločijo prek ledvic.