natgillin/translations-raw huggingface dataset:
Do not administer the unprepared vial components of the kit directly to a patient.
Sestavin nepripravljene viale kompleta ne uporabite neposredno pri bolniku.
% RCP = Counts (activity) in bottom half x 100
izmera (aktivnosti) na spodnji polovici x 100
Exposure to ionizing radiation is linked with cancer induction and a potential for the development of hereditary defects.
Izpostavljenost ionizirajočemu sevanju je povezana z nastankom raka in možnostjo razvoja dednih okvar.
a. Mark the chromatographic strip for origin, mid and solvent front lines with a pencil as shown below:
a. Listič za kromatografijo s svinčnikom označite z izvorno, sredinsko in sprednjo črto za topilo, kot je prikazano spodaj:
Lymphoseek has no or negligible influence on the ability to drive or use machines.
Zdravilo Lymphoseek nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The radiation doses to organs and tissues of an average patient (70 kg) per MBq of radiolabelled Lymphoseek are shown in Table 1 and Table 2.
Odmerki sevanja v organih in tkivih povprečnega bolnika (70 kg) na MBq radiološko označenega zdravila Lymphoseek so prikazani v preglednicah 1 in 2.
Potential for hypersensitivity or anaphylactic reactions The possibility of hypersensitivity including severe life-threatening fatal anaphylactic / anaphylactoid reactions must always be considered.
Potencial za preobčutljivost ali anafilaktične reakcije Vedno je treba upoštevati možnost preobčutljivosti, vključno s hudimi smrtno nevarnimi anafilaktičnimi/anafilaktoidnimi reakcijami.
Allow the solvent to migrate to the solvent front line (5 cm from the bottom of the Whatman strips and 3.5 cm for the Biodex strip).
Počakajte, da se topilo pomakne do sprednje črte za topilo (5 cm od dna lističev Whatman in 3,5 cm od dna lističev Biodex).
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
NAVODILA ZA PRIPRAVO RADIOFARMAKOV
The radiolabelled product is to be used within 6 hours of its preparation.
Radiooznačeno zdravilo je treba uporabiti v 6 urah po njegovi pripravi.
In the event of administration of a radiation overdose with tilmanocept the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding
V primeru uporabe prevelikega odmerka sevanja s tilmanoceptom je treba absorbirani odmerek zmanjšati, kadar je to mogoče, tako da se poveča izločanje radionuklida iz telesa s pogostim uriniranjem ali forsirano diurezo in pogostim praznjenjem mehurja.
There are no data from the use of Lymphoseek in pregnant women.
Podatkov o uporabi zdravila Lymphoseek pri nosečnicah ni.
Pharmacotherapeutic group: diagnostic radiopharmaceutical, tumour detection, ATC Code: V09IA09.
Farmakoterapevtska skupina: radiodiagnostiki, radiodiagnostiki za tumorje, oznaka ATC: V09IA09.
For precautions with respect to environmental hazard, see section 6.6.
Previdnostni ukrepi, povezaniz nevarnostjo za okolje, glejte poglavje 6.6.
Lymphoseek must not be used after the expiry date which is stated on the carton and label after “Exp”.
Zdravila Lymphoseek ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake »Uporabno do«.
However, it is required that the vial be prepared as instructed and a 50 microgram aliquot be used for a single patient dose; any remaining material should be discarded after reconstitution and use, see section 12.
Vendar je treba vialo pripraviti skladno z navodili in za enkratni odmerek pri bolniku uporabiti alikvot s 50 mikrogrami; ves preostali material je treba po rekonstituciji in uporabi zavreči; glejte 12. poglavje.
The use of Lymphoseek is intended to complement palpation, visual inspection, and other procedures important to lymph node localisation.
Uporaba zdravila Lymphoseek je namenjena dopolnjevanju palpacije, pregleda in drugih postopkov, pomembnih za lokalizacijo bezgavk.
For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Za pogoje shranjevanja po radiooznačevanju zdravila glejte poglavje 6.3.
Additional tracing agents should not be injected within 30 minutes of Lymphoseek administration.
Dodatni sledilci se ne smejo injicirati v 30 minutah po uporabi zdravila Lymphoseek.
Instructions for the reconstitution and radiolabelling of the product are included in this pack.
Navodila za rekonstitucijo in radiooznačevanje zdravila so priložena temu pakiranju.
Uncommon: Hypercalcaemia
Občasni: hiperkalciemija
This medicine is stored under the responsibility of the specialist in appropriate premises.
Za shranjevanje tega zdravila v ustreznih prostorih bo poskrbel specialist.
No dose adjustment is recommended based on age.
Prilagajanje glede na starost ni potrebno.
1 x 0.1 mL injection
1 x 0,1 ml injekcija
Preoperative lymphoscintigraphy was performed in 100% of melanoma patients, 100% of head and neck squamous cell carcinoma patients, and 82% of breast cancer patients.
Predoperacijsko limfoscintigrafijo so opravili pri 100 % bolnikov z melanomom, 100 % bolnikov s skvamoznim karcinomom glave in vratu ter 82 % bolnic z rakom dojke.
This medicine is for hospital use only.
To zdravilo je namenjeno samo za bolnišnično uporabo.
4.7 Effects on ability to drive and use machines
Vpliv na sposobnost vožnje in upravljanja s stroji
Use only eluate from technetium Tc 99m generator which was previously eluted within 8 hours.
Uporabite samo eluat iz generatorja tehnecija Tc99m, ki se je predhodno eluiral v 8 urah.
Intraoperative lymphatic mapping by gamma detection may begin as early as 15 minutes post-injection and within 30 hours (for next day surgery) of administration of Lymphoseek.
Medoperacijsko mapiranje bezgavk z zaznavanjem gama se lahko začne že 15 minut po injiciranju in v 30 urah (za kirurški poseg v naslednjem dnevu) po injiciranju zdravila Lymphoseek.
No reproductive toxicity studies in animals were performed, and it is not known if Lymphoseek can cause foetal harm when administered to a pregnant woman.
Izvedli niso nobenih študij vpliva na sposobnost razmnoževanja na živalih, zato ni znano, ali lahko zdravilo Lymphoseek poškoduje plod, kadar se uporabi pri nosečnicah.
These lymph nodes are where cancer cells are most likely to have spread.
Te bezgavke so na mestih, kamor se bo rak najverjetneje razširil.
Table 4: Example of three-sigma rule threshold Background counta
Preglednica 4: Primer mejnega pravila treh sigem Meritev v ozadjua
These reactions were temporally related to Lymphoseek administration and could be due to other medicinal products administered to patients or surgical procedures.
Ti neželeni učinki so bili glede na čas pojava povezani z zdravilom Lymphoseek, vendar so lahko posledica drugih zdravil, ki se dajejo bolnikom, ali kirurških posegov.
Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Pred uporabo radiofarmakov pri doječi materi je treba razmisliti o zamiku uporabe radionuklida, dokler mati ne neha dojiti, in o najustreznejši izbiri radiofarmakov, pri čemer je treba upoštevati izločanje aktivnosti sevanja v materino mleko.
The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
V vsakem primeru je treba uporabiti čim manjšo aktivnost, ki še omogoča pridobivanje potrebnih diagnostičnih podatkov.
• increased heart rate
• povišan srčni utrip,
Summary of safety profile
Neželeni učinki Povzetek varnostnega profila
ANNEX III LABELLING AND PACKAGE LEAFLET
PRILOGA III OZNAČEVANJE IN NAVODILO ZA UPORABO
• wound pain, wound opening or accumulation of fluid at surgical site
• bolečina na rani, odpiranje rane ali kopičenje tekočine na mestu kirurškega posega,
INFORMATION IN BRAILLE Justification for not including Braille accepted
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Use radiation shielding for radiolabelled Lymphoseek to prevent radiation exposure.
Za radiooznačeno zdravilo Lymphoseek uporabljajte ščit pred sevanjem, da preprečite izpostavljenost sevanju.
The overfill is 12.5 micrograms to allow for radiochemical purity testing and to ensure that 50 micrograms of tilmanocept can be delivered.
Dodatna čezmerna količina znaša 12,5 mikrogramov, da se omogoči radiokemično preizkušanje čistosti in zagotovi, da se bo dalo 50 mikrogramov tilmanocepta.
Clinical studies have evaluated the incidence of adverse reactions listed below in 553 subjects 18 years and above who received Lymphoseek.
Pogostnost spodaj navedenih neželenih učinkov so ocenili v kliničnih študijah pri 553 bolnikih, starih 18 let in več, ki so prejeli zdravilo Lymphoseek.
Store the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
However, after sodium pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained.
Ko se doda natrijev (99mTc)tehnecij-pertehnetat, pa je treba ves čas uporabljati ustrezen ščit pred sevanjem končnega pripravka.
Following reconstitution and labelling, Lymphoseek is intended to be injected in close proximity to the tumour and used in preoperative gamma detection imaging in conjunction with a stationary gamma camera (scintigraphy), single photon emissioncomputed tomography (SPECT), or SPECT/computerized tomography SPECT/CT, and/or intraoperatively in conjunction with a gamma detection probe to localise sentinel lymph nodes in the lymphatic pathway draining the tumour.
Po rekonstituciji in označevanju je treba zdravilo Lymphoseek injicirati v bližini tumorja, kar mora spremljati predoperacijsko slikanje z žarki gama v kombinaciji s stacionarno kamero gama (scintigrafijo), računalniško podprto scintigrafsko tomografijo s sevalci gama (single photon emissioncomputed tomography - SPECT) ali SPECT/računalniško tomografijo SPECT/CT in/ali medoperacijsko slikanje v kombinaciji s sondo gama za določanje mesta varovalnih bezgavk v limfnem žilju, v katere odtekajo maligne celice tumorja.
• feeling of warmth, a pricking or tingling sensation, or pain in an extremity, shoulder, the neck or jaw
• občutek vročice, mravljinčenje ali bolečina v okončini, rami, vratu ali čeljusti,
Sodium pertechnetate (Tc 99m) injection containing oxidants should not be used to reconstitute this kit.
Injekcija natrijevega pertehnetata (Tc99m), ki vsebuje oksidante, se ne sme uporabiti za rekonstitucijo tega kompleta.
c. Do not vent the tilmanocept powder vial prior to or during radiolabelling.
c. Pred ali med radiooznačevanjem ne prezračujte viale s praškom tilmanocepta.
What Lymphoseek is and what it is used for 2.
Kaj je zdravilo Lymphoseek in za kaj ga uporabljamo 2.
Technetium Tc 99m labelling reactions depend on maintaining the stannous ion in the reduced state.
Reakcije označevanja s tehnecijem Tc99m so odvisne od vzdrževanja kositrovega iona v zmanjšanem stanju.
The substance, tilmanocept, specifically binds to mannose binding receptor proteins (CD206) that reside on the surface of macrophages and dendritic cells.
Učinkovina, tilmanocept, se specifično veže na receptorske proteine (CD206), ki vežejo manozo in so na površini makrofagov in dendritičnih celic.
Lymphoseek finds the lymph nodes and can be detected using a special camera or detector.
Zdravilo Lymphoseek poišče bezgavke in ga je mogoče zaznati s posebno kamero ali detektorjem.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Postopke dajanja je treba izvajati tako, da se čim bolj zmanjša tveganje za kontaminacijo zdravila in obsevanje osebja.
Write the radioactivity amount, date and time of assay, volume, and expiration time (this is not to exceed 6 hours from preparation time) on a syringe label and affix it to the syringe(s).
Na nalepko za injekcijsko brizgo zabeležite količino radioaktivnosti, datum ter čas preizkusa, prostornino ter rok uporabnosti (ki ne presega 6 ur od časa priprave) in jo prilepite na brizgo(e).
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the radiolabelled product.
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali katero koli sestavino radiološko označenegaizdelka.
However, it is required that the vial be prepared as instructed and a 50 microgram aliquot be used for a single patient dose.
Vendar je treba vialo pripraviti skladno z navodili in za enkratni odmerek pri bolniku uporabiti alikvot s 50 mikrogrami.
Other medicines and Lymphoseek
Druga zdravila in zdravilo Lymphoseek
8 mL type I glass vial with a butyl rubber stopper sealed with a flip-off seal.
8-mililitrska steklena viala (steklo tipa I) z zamaškom iz butilne gume, zatesnjenim z zaporko (tipa »flipoff«).
Estimated radiation absorbed dose for melanoma, mGy/MBq Target organ
Ocena absorbiranega odmerka sevanja pri melanomu, mGy/MBq Ciljni organ
• Periodic safety update reports
• Redno posodobljena poročila o varnosti zdravila (PSUR)
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Posebna opozorila To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek,kar v bistvu pomeni »brez natrija«.
k. Withdraw the required volume of the radiolabelled product into the required number of syringes.
k. Potrebno prostornino radiooznačenega zdravila izvlecite v potrebno število injekcijskih brizg.
• If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
How to use Lymphoseek 4.
Kako uporabljati zdravilo Lymphoseek 4.
4.6 Fertility, pregnancy and lactation
Plodnost, nosečnost in dojenje
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
If you are allergic to tilmanocept or any of the other ingredients of this medicine (listed in section 6) or to any of the ingredients of the radiolabelled pharmaceutical.
Ne uporabljajte zdravila Lymphoseek: če ste alergični na tilmanocept ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali katero koli sestavino radiooznačenega zdravila.
For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.
Za navodila glede rekonstitucije in radiooznačevanja zdravila pred dajanjem glejte poglavje 12.
As with all general metabolites, especially those in which the liver plays a measurable roll of elimination, some biliary elimination of technetium Tc 99m tilmanocept is also likely to occur.
Kot pri vseh splošnih presnovkih, predvsem presnovkih, pri katerih imajo veliko vlogo pri izločanju jetra, je verjetno, da bo prišlo do nekaj izločanja s tehnecijem Tc99m označenega tilmanocepta z žolčem.
l. Store the radiolabelled product in a shield.
l. Radiooznačeno zdravilo shranite v ščitu.
Estimated dose absorbed from Lymphoseek in patients with melanomaa
Ocena odmerka, absorbiranega iz zdravila Lymphoseek, pri bolnikih z melanomoma
Lymphoseek may be administered to a patient as a single injection or as multiple injections.
Zdravilo Lymphoseek se lahko bolnikom daje v obliki enkratnega ali večkratnega injiciranja.
Pack-size of 1 and 5 vials.
Velikost pakiranja je 1 ali 5 vial.
Since technetium (99mTc) tilmanocept contains a small amount of radioactivity it can make parts of the body areas visible to doctors during tests to help them see if the cancer has spread to places called ‘lymph nodes' that are found near tumours.
Ker vsebuje tehnecijev (99mTc) tilmanocept majhno količino radioaktivnosti, zdravnikom omogoča pregledovanje delov telesa med preiskavami, s čimer ugotovijo, ali se je rak razširil na bezgavke v okolici tumorjev.
Tilmanocept may be metabolised in the liver to its component molecules, namely dextran (which is renally excreted and/or further metabolised to glucose), mannose (an endogenous sugar) and diethylenetriaminepentaacetic acid (which is renally excreted).
Tilmanocept se lahko v jetrih presnovi na sestavne molekule, tj. dekstran (ki se izloča skozi ledvice in/ali nadalje presnovi v glukozo), manozo (endogeni sladkor) in dietilentriaminpentaocetno kislino (ki se izloča skozi ledvice).
Marketing Authorisation Holder Norgine B.V.
Imetnik dovoljenja za promet z zdravilom Norgine B.V.
• After injection of Lymphoseek, external gamma detection imaging may be conducted.
• Po injiciranju zdravila Lymphoseek lahko opravite zunanje slikanje z žarki gama.
Administration of Lymphoseek and conduct of the procedure Lymphoseek is injected under the skin, under the nipple, or in or around the tumour.
Injiciranje zdravila Lymphoseek in izvajanje postopka Zdravilo Lymphoseek se injicira pod kožo, pod prsno bradavico ali v tumor ali njegovo okolico.
Mid Line
Sredinska črta
The medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting sentinel lymph node mapping procedures.
Zdravilo smejo uporabljati samo usposobljeni zdravstveni delavci s tehničnim znanjem o izvajanju in interpretaciji postopkov za mapiranje varovalnih bezgavk.
No clinical consequences were observed at dose levels of 3.7 times the recommended dose of Lymphoseek in humans, or at 390 times the anticipated human exposure of tilmanocept in animals.
Pri odmerkih, 3,7-krat večjih od priporočenega odmerka zdravila Lymphoseek pri človeku ali 390-krat večjih od pričakovane izpostavljenosti človeka tilmanoceptu pri živalih, niso opazili nobenega kliničnega odziva.
Following radiolabelling, administration can be by either intradermal, subcutaneous, intratumoural, or peritumoural injection.
Po radiološki označbi se lahko uporabi za intradermalno, subkutano, intratumorno ali peritumorno injiciranje.
Should you have any further questions on the use of Lymphoseek, please ask the nuclear medicine doctor who supervises the procedure.
Če imate kakršna koli dodatna vprašanja o uporabi zdravila Lymphoseek, se posvetujte z zdravnikom nuklearne medicine, ki nadzoruje postopek.
In clinical studies using Lymphoseek, study investigators employed a threshold rule for positive localisation of technetium Tc 99m that was estimated using the background radioactivity counts plus three standard deviations from the mean background count level (i.e., the three-sigma rule, representing >99.7% probable difference from background) [see Table 4].
V kliničnih študijah zdravila Lymphoseek so raziskovalci uporabili mejno pravilo za pozitivno lokalizacijo tehnecija Tc99m, ki so ga ocenili z meritvijo radioaktivnosti v ozadju in tremi standardnimi odkloni od povprečne meritve v ozadju (tj. pravilo treh sigem, kar predstavlja > 99,7-odstotno verjetno razlikovanje od ozadja) (glejte preglednico 4).
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Sevanje pri radionuklidnih postopkih pri nosečnicah učinkuje tudi na plod.
Each Lymphoseek vial, once reconstituted and radiolabelled, would contain 50 micrograms of product with an additional overfill when prepared according to the instructions and administered as noted in Table 3.
Ena viala zdravila Lymphoseek bo po rekonstituciji in radiooznačevanju vsebovala 50 mikrogramov zdravila z dodatno čezmerno količino, če ste ga pripravili skladno z navodili in injicirali, kot je navedeno v preglednici 3.
For melanoma, administration is intradermal in single or multiple divided injections.
Pri melanomu je uporaba intradermalna v obliki enkratnega ali večkratnega ločenega injiciranja.
Biodex 150-001 Red Strips b. Apply a small drop (3 - 10 microliters) of the radiolabelled product at the center of the origin line chromatography strip.
Listič Biodex 150-001 Red Strips b. Na sredino izvorne črte na lističu za kromatografijo nanesite kapljico (3-10 mikrolitrov) radiooznačenega zdravila.
Fertility Animal fertility studies have not been conducted with Lymphoseek.
Plodnost Študij zdravila Lymphoseek na živalih niso izvedli.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Shield label to be applied after radiolabelling
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Nalepka za ščit, ki jo je treba nalepiti pred radiooznačevanjem
If there is more than one sentinel lymph node, they will remove these nodes as well.
Če je prisotnih več bezgavk, jih bo prav tako odstranil.
The pharmacokinetics of technetium Tc 99m tilmanocept in patients with renal or hepatic impairment have not been characterised (see section 5.2).
Farmakokinetike s tehnecijem Tc99m označenega tilmanocepta niso določili pri bolnikih z ledvično ali jetrno okvaro (glejte poglavje 5.2).
For instructions for preparation and control of the radiochemical purity of the radiopharmaceutical, see section 12.
Za navodila glede priprave in nadzora radiokemijske čistote radiofarmaka glejte poglavje 12.
For breast cancer, administration is intradermal, subareolar (single or multiple divided injections) or peritumoural (multiple divided injections).
Pri raku dojke je uporaba intradermalna ali subareolarna (enkratno ali večkratno ločeno injiciranje) ali peritumorna (večkratno ločeno injiciranje).
What Lymphoseek is and what it is used for
Kaj je zdravilo Lymphoseek in za kaj ga uporabljamo
Use within 6 hours of radiolabelling.
Po radiooznačevanju 6 ur.
• All lymphatic mapping agents use elements of the lymphatic system for distribution.
• Vse učinkovine za mapiranje bezgavk za razporeditev uporabljajo elemente limfnih obtočil.
The vial components of the kit are sterile, non-pyrogenic, and are intended solely for use in the preparation of Lymphoseek.
Sestavine kompleta v viali so sterilne, apirogene in namenjene samo uporabi pri pripravi zdravila Lymphoseek.
Adults brain breast (injection site) gall bladder wall lower large intestine wall small intestine stomach upper large intestine wall kidney liver lungs muscle ovaries red marrow bone spleen testes thymus thyroid urinary bladder total body (blood)b
Odrasli možgani dojka (mesto injiciranja) stena žolčnika stena spodnjega debelega črevesa tanko črevo želodec stena zgornjega debelega črevesa ledvica jetra pljuča mišice jajčniki rdeči kostni mozeg kosti vranica testisi timus ščitnica sečni mehur celotno telo (kri)b
Lymphoseek, radiolabelled solution for injection should be used within 6 hours after reconstitution.
Radiooznačeno raztopino za injiciranje zdravila Lymphoseek je treba uporabiti v 6 urah po rekonstituciji.
Specific warnings
Splošno opozorilo
If administration is considered necessary, breast-feeding should be interrupted for 24 hours post injection and the expressed feeds discarded.
Če je uporaba nujna, je treba dojenje po injiciranju prekiniti za 24 ur, izločeno mleko pa zavreči.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Based on the planned number of injection syringes and the planned total injection volume per patient, determine (from Table 3 below) the reconstituted vial volume of radiolabelled Lymphoseek.
Na podlagi načrtovanega števila injekcijskih brizg in načrtovane skupne prostornine injiciranja na bolnika določite rekonstituirano prostornino radiooznačenega zdravila Lymphoseek.
Uncommon: Breast pain
Občasni: bolečina v dojki
Radiation protection precautions in accordance with national regulations must therefore be taken.
Zato je treba sprejeti varnostne ukrepe za zaščito pred sevanjem v skladu z nacionalnimi predpisi.
5 x 0.2 mL injections, or 4 x 0.25 mL injections, or 2 x 0.5 mL injections
5 x 0,2 ml injekcije ali 4 x 0,25 ml injekcije ali 2 x 0,5 ml injekciji