natgillin/translations-raw huggingface dataset:
This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.
Zdravilo ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let, saj ga niso preučevali pri tej starostni skupini.
• difficulty speaking
• težave pri govoru,
Origin Line 1 cm from Bottom
Izvorna črta 1 cm od dna
Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezne licence pristojnega organa.
Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
Starejše bolnike, stare 65 let ali več (32 %), so ocenili v kliničnih študijah; ugotovili niso nobenih težav z varnostjo.
The dose may be divided up into smaller amounts.
Odmerek se lahko razdeli na več majhnih količin.
For each injection prepare a separate syringe.
Za vsako injiciranje pripravite ločeno injekcijsko brizgo.
Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 to < 1/10); občasni (≥ 1/1.000 to < 1/100); redki (≥ 1/10.000 to < 1/1.000); zelo redki (< 1/10.000) in neznani (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
b Blood represents total body exposure segregated from independent measurements of other organs and tissues.
b Kri predstavlja izpostavljenost celotnega telesa, ločenega od posameznih meritev za druge organe in tkiva.
If at any time in the preparation of this medicinal product the integrity of this vial is compromised it should not be used.
Če je kadar koli med pripravo tega zdravila ogrožena integriteta viale, izdelka ne smete uporabiti.
Affix the label to the shield.
Nalepko nalepite na ščit.
Do not use if particulate matter and/or discoloration are seen.
Ne uporabite, če so vidni delci in/ali razbarvanje.
Whatman Grade 1, 3MM, 31ET Chromatography strip
Listič Whatman Grade 1, 3MM, 31ET Chromatography strip
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Pri vsaki ženski, ki ni dobila menstruacije, je treba domnevati, da je noseča, dokler se ne dokaže nasprotno.
The safety and efficacy of Lymphoseek in children and adolescents below the age of 18 years has not yet been established.
Varnost in učinkovitost zdravila Lymphoseek pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
Elderly population
Starejša populacija
However, in the case of an overdose, you will receive the appropriate treatment.
Če kljub temu pride do prevelikega odmerjanja, boste prejeli ustrezno zdravljenje.
Adequate shielding is mandatory.
Ustrezen ščit je obvezen.
Lymphoseek will only be used in special controlled areas.
Zdravilo Lymphoseek se bo uporabljalo samo v posebno nadzorovanih prostorih.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Za takojšnje ukrepanje v nujnih primerih morajo biti vedno takoj na razpolago potrebna zdravila in oprema, kot sta endotrahealni tubus in ventilator.
This includes medicines obtained without a prescription and herbal medicines.
To vključuje zdravila, ki ste jih dobili brez recepta, in zeliščna zdravila.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
Radiation safety - Product handling
Varnost pri sevanju - ravnanje z zdravilom
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Obstajajo strogi zakoni o uporabi in odstranjevanju radiofarmakov ter ravnanju z njimi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se ne porabi takoj, je uporabnik odgovoren za čas in pogoje shranjevanja pred uporabo.
Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Trajanje postopka Zdravnik nuklearne medicine vas bo obvestil o običajnem trajanju postopka.
g. Remove the needle, gently swirl the vial to mix the contents, and then let it stand at room temperature for at least 15 minutes.
g. Odstranite iglo, nežno pretresite vialo, da vrtinčite vsebino, potem pa vialo pustite na sobni temperaturi vsaj 15 minut.
Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Izčrpnih študij o razponih in prilagajanju odmerka zdravila pri normalnih in posebnih populacijah niso izvedli.
CAUTION RADIOACTIVE MATERIAL
POZOR RADIOAKTIVNI MATERIAL
Appropriate aseptic precautions should be taken.
Sprejeti je treba ustrezne ukrepe za zagotavljanje aseptičnih pogojev.
The following information is intended for the specialist only.
Naslednje informacije so namenjene samo specialistom.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pred začetkom dajanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Prior to preparation, determine the planned injection technique and the number of injections that will be used for a given patient.
Pred pripravo določite načrtovano tehniko injiciranja in število injiciranj, ki jih boste uporabili pri posameznem bolniku.
Do not use if vial integrity appears compromised.
Ne uporabite, če je neoporečnost viale ogrožena.
• frequent or urgent need to urinate
• pogosta in velika nuja po uriniranju,
Vials are sealed under nitrogen; air or oxygen is harmful to the contents of the vial and therefore the vial should not be vented.
Viale so zatesnjene v dušiku; zrak in kisik škodujeta vsebini viale, zato je ni dovoljeno prezračevati.
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Med nosečnostjo je zato treba izvajati samo nujne preiskave, pri katerih je verjetna korist precej večja od tveganja za mater in plod.
The content of the kit before extemporary preparation is not radioactive.
Vsebina kompleta pred pripravo ni radioaktivna.
The radiolabelled solution is stable for 6 hours at a maximum of 25°C.
Radiooznačena raztopina je stabilna 6 ur pri največ 25°C.
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 zdravila in vas bodo sproti obveščale o svojem ravnanju.
Follow aseptic procedures during preparation and administration.
Med pripravo in dajanjem upoštevajte aseptične postopke.
Your doctor and nuclear medicine doctor will tell you when it is safe to drive after your surgery.
Vaš osebni zdravnik in zdravnik nuklearne medicine vam bosta povedala, kdaj je varno voziti po vašem kirurškem posegu.
• if you have experienced any signs of allergic reaction (listed in section 4) after previous admistration of Lymphoseek
• če ste imeli kakršne koli znake alergijske reakcije (navedene v poglavju 4) po predhodni uporabi zdravila Lymphoseek ;
It is not a treatment for your illness.
To zdravilo ne zdravi vaše bolezni.
Total volume: ________mL
Skupna prostornina: ________ml
d. Calculate the percent radiochemical purity (% RCP) as follows:
d. Odstotek radiokemijske čistote (% RCP - radiochemical purity) izračunajte na naslednji način:
Effective preoperative imaging procedures include planar gamma camera scintigraphy, SPECT, and SPECT/CT.
Učinkoviti postopki predoperacijskega slikanja vključujejo ravninsko scintigrafijo s kamero gama, SPECT in SPECT/CT.
The radionuclide is not part of the kit.
Radionuklid ni del kompleta.
If you are pregnant, the nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.
Če ste noseči, bo zdravnik nuklearne medicine to zdravilo med nosečnostjo uporabil samo, če je pričakovano, da bo korist večja od tveganj.
That means it is essentially ‘sodium-free'.
To pomeni, da je skoraj »brez natrija«.
The nuclear medicine doctor supervising the procedure will decide the quantity of Lymphoseek to be used in your case.
Zdravnik nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila Lymphoseek, ki bo uporabljena pri vas.
This means that it is used in breast cancer, melanoma or oral cavity cancers to help find out about your illness.
To pomeni, da se uporablja pri raku dojke, melanomu ali raku ustne votline za pridobivanje podatkov o vaši bolezni.
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc.
Dajanje radiofarmakov predstavlja tveganje za druge osebe zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja itd.
The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
The quantity to be administered usually recommended for an adult ranges from 18.5 to 74 MBq (megabecquerel, the unit used to express radioactivity).
Uporabljena količina, navadno priporočena za odrasle, je od 18,5 do 74 MBq (megabekerel, enota, ki se uporablja za izražanje radioaktivnosti).
Two Phase 1 clinical trials in breast cancer patients and one Phase 1 study in melanoma patients have been completed.
Zaključili so dve klinični preskušanji 1. faze pri bolnicah z rakom dojke in eno študijo 1. faze pri bolnikih z melanomom.
Adverse reactions observed during clinical studies are listed below by frequency category.
Neželeni učinki, ugotovljeni v kliničnih študijah, so našteti spodaj po kategorijah pogostnosti.
Calibration time: ________Time/Date
Čas umerjanja: ________čas/datum
The use of Lymphoseek does involve exposure to small amounts of radioactivity.
Uporaba zdravila Lymphoseek vključuje izpostavljenost majhnim količinam radioaktivnosti.
Uncommon: Sinus tachycardia
Občasni: sinusna tahikardija
• In clinical studies, patients received Lymphoseek up to 30 hours before surgery.
• V kliničnih študijah so bolniki zdravilo Lymphoseek prejeli do 30 ur pred kirurškim posegom.
When an administration of radiopharmaceuticals 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.
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Zdravnik nuklearne medicine vas bo obvestil, ali morate po prejemu tega zdravila uporabljati kakršne koli posebne previdnostne ukrepe.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih
The patient should be well hydrated before the start of the examination and frequent voiding of urine during the initial hours after examination would reduce radiation exposure to the patient.
Bolnik mora biti pred začetkom preiskave dobro hidriran, saj bo pogosto uriniranje v prvih urah po preiskavi zmanjšalo izpostavljenost bolnika sevanju.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vam dajo to zdravilo.
These rates were significantly greater (p<0.0001) against a random effects meta-analysis of localisation rates from published literature for colloidal lymphatic mapping agents as used in European clinical practice.
Ti deleži so bili pomembno večji (p < 0,0001) v primerjavi z metaanalizo deležev lokalizacije z naključnimi učinki iz objavljene literature za koloide za mapiranje bezgavk, kot se uporabljajo v evropski klinični praksi.
The radiation dose estimation for a number of organs is based on MIRD reference man and MIRD S values, and has been calculated from biological data of organ uptake and blood clearance.
Ocena odmerka sevanja za številne organe temelji na referenčni vrednosti MIRD za moške ter vrednostih MIRD S in je bila izračunana na podlagi bioloških podatkov o privzemu v organih ter očistku iz krvi.
The European Medicines Agency has deferred the obligation to submit the results of studies with Lymphoseek in one or more subsets of the paediatric population for visualisation of lymphatic drainage of solid malignant tumours for diagnostic purposes (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Lymphoseek za eno ali več podskupin pediatrične populacije pri vizualizaciji limfne drenaže solidnih malignih tumorjev za diagnostične namene (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Vaš osebni zdravnik in zdravnik nuklearne medicine sta presodila, da klinične koristi tega postopka z radiofarmakom pri vas odtehtajo tveganje zaradi sevanja.
Other adverse reactions were uncommon, and of mild severity and short duration.
Drugi neželeni učinki so bili občasni, blagi in kratkotrajni.
Counts(activity) in bottom half + Counts(activity) in top half e. Do not use the radiolabelled Lymphoseek if the radiochemical purity is less than 90%.
izmera (aktivnosti) na spodnji polovici + izmera (aktivnosti) na zgornji polovici e. Ne uporabljajte radiooznačenega zdravila Lymphoseek, če je radiokemjska čistota manjša od 90 %.
Pack sizes The glass vials are supplied in a carton containing 1 or 5 vials.
Velikost pakiranja Steklene viale so na voljo v škatlah z 1 ali 5 vialami.
Although these are complementary to intraoperative gamma probing, such acquired images should not be considered a substitute for proficient and thorough intraoperative probing with a handheld gamma detection probe.
Čeprav ti postopki dopolnjujejo medoperacijsko sondiranje gama, tako zajete slike niso nadomestilo za strokovno in temeljito medoperacijsko sondiranje z ročno sondo za zaznavanje žarkov gama.
• The active substance is tilmanocept.
• Zdravilna učinkovina je tilmanocept.
c. Place the strip into a chromatography chamber containing 1 mL of acetone as the developing solvent.
c. Listič položite v komoro za kromatografijo, ki vsebuje 1 ml acetona kot topila za razvijanje.
Patient preparation
Priprava bolnika
Three-sigma threshold value a Average of three 2-second counts or one 10-second count
Mejna vrednost treh sigem a Povprečje treh 2-sekundnih meritev ali ene 10-sekundne meritve
External imaging and intraoperative evaluation may be performed using a gamma detection device.
Zunanje slikanje in medoperacijska ocena se lahko opravita z uporabo naprave za zaznavanje žarkov gama.
Effective dose (E) (males, mSv/MBq)
Učinkoviti odmerek (E) (moški, mSv/MBq)
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
Ta radiofarmak bo dovajal majhne količine ionizirajočega sevanja, povezanega z najmanjšim tveganjem za raka in prirojene nepravilnosti.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je treba pripraviti na način, ki bo zadostil zahtevam glede zaščite pred sevanjem in farmacevtske kakovosti.
The following side effects may happen with this medicine:
Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki:
• if you have kidney or liver problems (renal or heptatic disease)
• če imate težave z ledvicami ali jetri (bolezen ledvic ali jeter).
j. Determine the radiochemical purity of the radiolabelled product as described below.
j. Določite radiokemijsko čistoto radiooznačenega zdravila, kot je opisano spodaj.
The complete SmPC of Lymphoseek is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Celoten povzetek glavnih značilnosti zdravila Lymphoseek je na voljo kot odtrgljivi del na koncu tiskanega navodila v pakiranju zdravila, njegov cilj pa je zdravstvenim delavcem ponuditi druge dodatne znanstvene in praktične informacije o injiciranju in uporabi tega radiofarmaka.
In clinical trials with 553 patients, the most common adverse reactions were: ◦ Injection site irritation (0.7%; 4 of 553 patients) ◦ Injection site pain (0.2%; 1 of 553 patients)
V kliničnih preskušanjih s 553 bolniki sta bila najpogostejša neželena učinka: ◦ draženje na mestu injiciranja (0,7 %; 4 bolniki od 553), ◦ bolečina na mestu injiciranja (0,2 %; 1 bolnik od 553).
Radiopharmaceuticals should be used by or under the control of healthcare professionals who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radionuclides.
Radiofarmake smejo uporabljati zdravstveni delavci, ki so bili posebej usposobljeni in imajo izkušnje na področju varne uporabe radionuklidov ter ravnanja z njimi, katerih usposabljanje in izkušnje je odobrila ustrezna vladna agencija, pooblaščena za izdajanje licenc za uporabo radionuklidov.
As the effective dose to an adult (70 kg) is 0.69 mSv when the maximal recommended activity of 74 MBq is administered adverse reactions are expected to occur with a low probability.
Ker je učinkoviti odmerek za odrasle (70 kg) 0,69 mSv, kadar je največja priporočena aktivnost 74 MBq, je verjetnost pojava teh neželenih učinkov majhna.
Kit for radiopharmaceutical preparation 1 vial
komplet za pripravo radiofarmaka 1 viala
This product will only be handled and given to you by people who are trained to use it safely.
Z zdravilom bodo ravnale in vam ga dale samo osebe, usposobljene za njegovo varno uporabo.
If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Če se pojavi preobčutljivost ali anafilaktična reakcija, je treba uporabo zdravila nemudoma prekiniti in po potrebi uvesti intravensko zdravljenje.
To normalize pressure, withdraw an equal volume of headspace gas.
Za normalizacijo tlaka izvlecite enako prostornino plina nad tekočino.
If you have been given more Lymphoseek than you should An overdose is unlikely because you will get a specially measured amount of Lymphoseek precisely controlled by the doctor supervising the procedure.
Če ste prejeli večji odmerek zdravila Lymphoseek, kot bi smeli Preveliko odmerjanje ni verjetno, saj boste prejeli posebej izmerjeno količino zdravila Lymphoseek, zdravnik pa bo nadzoroval postopek.
The purpose of the studies included the radiopharmacokinetic evaluation of Lymphoseek.
Namen teh študij je med drugim vključeval radiofarmakokinetično oceno zdravila Lymphoseek.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA
The total contents of the vial should not be administered to a single patient.
Celotne vsebine viale ne smete uporabiti pri enem bolniku.
This medicine is for diagnostic use in adults only.
To zdravilo je namenjeno samo diagnostični uporabi pri odraslih.
The radiolabelled product is a clear, colourless solution with no visible particles.
Radiološko označeno zdravilo je prozorna brezbarvna raztopina brez vidnih delcev.
Background counts were typically determined from tissue at least 20 centimetres distal to the injection site.
Meritve v ozadju so navadno izvedli na tkivu, vsaj 20 centimetrov distalno od mesta injiciranja.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total activity: ________MBq
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Skupna aktivnost: ________MBq
For patient preparation, see section 4.4.
Za navodila glede priprave bolnika glejte poglavje 4.4.
Based on clinical studies, the rate of localisation (percent of all patients with at least one hot node) and degree of localisation (average number of hot nodes per patient) of Lymphoseek is not dependent on the radiopharmaceutical injection technique.
V kliničnih študijah so ugotovili, da delež lokalizacije (odstotek vseh bolnikov z vsaj eno pozitivno bezgavko) in stopnja lokalizacije (povprečno število pozitivnih bezgavk na bolnika) pri zdravilu Lymphoseek nista odvisna od tehnike injiciranja radiofarmaka.
For injection after radiolabelling.
Za injiciranje po radiooznačevanju.
1 vial
1 viala
The surgeon will also use a machine that finds the 99mTc part of the medicine.
Kirurg bo prav tako uporabil napravo, ki odkrije del zdravila s 99mTc.
Radiopharmaceuticals should be received, used, and administered only by authorised persons in designated clinical settings.
Radiofarmake sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v pooblaščenih klinikah.
The recommended minimum time for imaging is 15 minutes post injection.
Priporočen najmanjši čas slikanja je 15 minut po injiciranju.
Contents of the vial are intended only for use in the preparation and radiolabelling of Lymphoseek and are not to be administered directly to the patient without first undergoing the preparative procedure.
Vsebina vial je namenjena samo za uporabo pri pripravi in radiooznačevanju zdravila Lymphoseek in se ne sme dajati neposredno bolniku, preden se opravi postopek priprave.
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, je njena menstruacija zelo neredna ipd.), je treba bolnici ponuditi alternativne tehnike, ki ne vključujejo ionizirajočega sevanja (če so na voljo).
Recommended time for preoperative imaging is 15 minutes post-injection but may begin as early as 10 minutes.
Priporočeni čas za predoperacijsko slikanje je 15 minut po injiciranju, vendar se lahko začne že po 10 minutah.
• irritation or pain where the injection is given (including the breast and skin)
• draženje ali bolečina na mestu injiciranja (vključno z dojko in kožo),
Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Lymphoseek to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
Pri ravnanju z zdravilom Lymphoseek uporabljajte vodotesne rokavice, učinkovit ščit pred sevanjem in ustrezne varnostne ukrepe, da preprečite nepotrebno izpostavljenost bolnika, delavcev, kliničnega osebja in drugih oseb sevanju.