FrancophonIA/ELRC3.0 huggingface dataset:
English: Disconnect the oral syringe by gently twisting it out of the bottle.
Slovenian: Izvlecite brizgo tako, da jo nežno zasučete iz steklenice.
English: Note the date when the bottle is removed from the refrigerator on the bottle label.
Slovenian: Zabeležite datum, ko je bila steklenica vzeta iz hladilnika, na nalepko na steklenici.
English: Oral use only.
Slovenian: Samo za peroralno uporabo.
English: 4 mg/ml oral suspension:
Slovenian: 4 mg/ml peroralna suspenzija:
English: Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (figure A).
Slovenian: Močno stresajte steklenico najmanj 20 sekund, dokler se trdna usedlina na dnu steklenice povsem ne razpusti (slika A).
English: If any air bubbles are observed inside the filled oral syringe, the plunger should be pushed back up until the air bubbles are expelled.
Slovenian: Če so znotraj napolnjene brizge za peroralno dajanje opazni mehurčki, je treba bat potisniti nazaj navzgor, dokler se mehurčki ne iztisnejo.
English: The oral suspension is a white, slightly thicker opaque suspension.
Slovenian: Peroralna suspenzija je bela, nekoliko gostejša motna suspenzija.
English: Capsule shell gelatin titanium dioxide (E 171)
Slovenian: Vsebina kapsule predgeliran (koruzni) škrob Ovojnica kapsule želatina titanov dioksid (E 171)
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo Orfadin Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: It is important to carefully follow the instructions given below for preparation and administration of the dose, in order to ensure the dosing accuracy.
Slovenian: Pomembno je, da se točno upošteva navodila, dana spodaj, za pripravo in dajanje odmerka, da se zagotovi natančnost odmerjanja.
English: The medicine can be stored for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which it must be discarded.
Slovenian: Zdravilo lahko shranjujete zunaj hladilnika največ 2 meseca (2 mg kapsule) ali 3 mesece (5 mg, 10 mg in 20 mg kapsule) pri temperaturi do 25 °C, potem ga je treba zavreči.
English: Each ml contains 1 mg. Increase in bilirubin following its displacement from albumin, caused by benzoic acid and its salts, may increase jaundice in pre-term and full-term jaundiced neonates and develop into kernicterus (unconjugated bilirubin deposits in the brain tissue).
Slovenian: Povečanje bilirubina po spodrinjenju iz albumina, ki ga povzročijo benzojska kislina in njene soli, lahko poveča zlatenico pri nedonošenčkih in donošenih novorojenčkih z zlatenico in se razvije v kernikterus (nekonjugirane usedline bilirubina v možganskem tkivu).
English: Oral suspension 1 bottle of 90 ml, 1 bottle adaptor, 3 oral syringes (1 ml, 3 ml, 5 ml).
Slovenian: 1 steklenica z 90 ml suspenzije, 1 nastavek za steklenico, 3 brizge za peroralno dajanje (1 ml, 3 ml, 5 ml).
English: • The 5 ml oral syringe (the largest oral syringe), is marked from 1 ml to 5 ml with minor 0.2-ml graduations.
Slovenian: • 5-ml brizga za peroralno dajanje (največja brizga za peroralno dajanje) ima oznake od 1 ml do 5 ml z najmanjšimi razdelki 0,2 ml.
English: In order to withdraw the prescribed dose (ml), pull the plunger slowly down until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Slovenian: Da bi dobili predpisani odmerek (ml), potegnite bat počasi navzdol dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek (slika F).
English: Printing ink: iron oxide (E 172) shellac propylene glycol ammonium hydroxide
Slovenian: železov oksid (E 172) šelak propilenglikol amonijev hidroksid
English: The suspension is administered in the patient's mouth with an oral syringe without dilution.
Slovenian: Način uporabe Suspenzija se daje bolniku v usta z brizgo za peroralno dajanje brez redčenja.
English: In order to withdraw the prescribed dose (ml), the plunger should be pulled down slowly until the top edge of the black ring is exactly level with the line marking the dose (Figure F).
Slovenian: Da bi izvlekli predpisani odmerek (ml) je treba bat počasi povleči navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek (slika F).
English: How to prepare the dose to be administered
Slovenian: Kako pripraviti odmerek za dajanje
English: During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded.
Slovenian: 2 leti Med rokom uporabnosti lahko bolnik shranjuje kapsule pri temperaturi do 25 °C le 2 meseca (2 mg kapsule) ali 3 mesece (5 mg, 10 mg in 20 mg kapsule), potem pa jih mora zavreči.
English: CONTENTS BY UNIT
Slovenian: VSEBINA, IZRAŽENA S ŠTEVILOM ENOT
English: Dose conversion tables respectively for the three oral syringe sizes:
Slovenian: Preglednice za pretvorbo odmerka za tri velikosti brizg za peroralno dajanje:
English: Each pack contains one bottle, one LDPE bottle adapter and 3 polypropylene (PP) oral syringes (1 ml, 3 ml and 5 ml).
Slovenian: Eno pakiranje vsebuje eno steklenico, en nastavek iz LDPE za steklenico in 3 polipropilenske (PP) brizge za peroralno dajanje (1 ml, 3 ml in 5 ml).
English: Sodium Each ml contains 0.7 mg (0.03 mmol).
Slovenian: En ml vsebuje 0,7 mg (0,03 mmol).
English: Figure F.
Slovenian: Slika F
English: It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year.
Slovenian: Nadziranje ravni tirozina v plazmi Pred začetkom zdravljenja z nitizinonom in nato redno, a vsaj enkrat na leto, je priporočljivo opraviti pregled oči s špranjsko svetilko.
English: Keep the bottle in an upright position and insert the oral syringe firmly into the hole at the top of the bottle (figure E).
Slovenian: Držite steklenico v pokončnem položaju in čvrsto vstavite brizgo za peroralno dajanje v odprtino na nastavku na vrhu steklenice (slika E).
English: If any air bubbles are observed inside the filled oral syringe, push the plunger back up until the air bubbles are expelled.
Slovenian: Če opazite znotraj napolnjene brizge za peroralno dajanje mehurčke, potisnite bat nazaj navzgor, dokler ne iztisnete mehurčkov.
English: It is provided in a 100 ml brown glass bottle with a white, child resistant screw cap. Each bottle contains 90 ml supension.
Slovenian: Na voljo je v 100 ml rjavi steklenici z belo za otroke varno navojno zaporko.
English: Orfadin 4 mg/ml oral suspension Nitisinone
Slovenian: Orfadin 4 mg/ml peroralna suspenzija nitizinon
English: Immediately thereafter, open the bottle by removing the child resistant screw cap. 3.
Slovenian: Takoj potem odprite steklenico tako, da odstranite za otroke varno navojno zaporko.
English: It is used for measuring doses of more than 1 ml and up to 3 ml.
Slovenian: Uporablja se za merjenje odmerkov do največ 3 ml.
English: How to store Orfadin
Slovenian: Shranjevanje zdravila Orfadin
English: • The 3 ml oral syringe (the middle sized oral syringe), is marked from 1 ml to 3 ml with minor 0.1-ml graduations.
Slovenian: • 3-ml brizga za peroralno dajanje (srednje velika brizga za peroralno dajanje) ima oznake od 1 ml do 3 ml z najmanjšimi razdelki 0,1 ml.
English: Remove the child resistant screw cap by pushing it down firmly and turning it anti-clockwise (figure B).
Slovenian: Odstranite za otroke varno navojno zaporko tako, da jo močno pritisnete navzdol in obrnete v nasprotni smeri urnega kazalca (slika B).
English: The child-resistant screw cap should be removed by pushing it down firmly and turning it anticlockwise (Figure B).
Slovenian: Za otroke varno navojno zaporko je treba odstraniti tako, da se jo močno pritisne navzdol in obrne v nasprotni smeri urnega kazalca (slika B).
English: Figure B.
Slovenian: Slika B
English: The pack contains a bottle of medicine with a cap, a bottle adaptor and three oral syringes (1 ml, 3 ml and 5 ml).
Slovenian: Pakiranje vsebuje steklenico zdravila z zaporko, nastavek za steklenico in tri brizge za peroralno dajanje (1 ml, 3 ml in 5 ml).
English: Immediately thereafter, the bottle should be opened by removing the child-resistant screw cap. 3.
Slovenian: Takoj potem je treba steklenico odpreti tako, da se odstrani za otroke varna navojna zaporka.
English: By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate.
Slovenian: HT-1, nitizinon prepreči akumulacijo toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
English: Then pull the plunger down again until the top edge of the black ring is exactly level with the line marking the dose.
Slovenian: Nato potegnite bat spet navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek.
English: 5 mg, 10 mg, 20 mg: Store in a refrigerator.
Slovenian: Datum odvzema zdravila iz hladilnika: 5 mg, 10 mg in 20 mg: Shranjujte v hladilniku.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Orfadin Vsebina pakiranja in dodatne informacije
English: Carefully turn the bottle upside down with the oral syringe in place (Figure F).
Slovenian: Previdno obrnite steklenico z nameščeno brizgo za peroralno dajanje z vrhom navzdol (slika F).
English: Orfadin 4 mg/ml oral suspension
Slovenian: Orfadin 4 mg/ml peroralna suspenzija
English: Then the plunger should be pulled down again until the top edge of the black ring is exactly level with the line marking the dose.
Slovenian: Nato je treba bat spet povleči navzdol, dokler ni zgornji rob črnega obročka poravnan s črto, ki označuje odmerek.
English: The bottle should be closed with the child resistant screw cap.
Slovenian: Steklenico je treba zapreti z za otroke varno navojno zaporko.
English: Follow the instructions given below for dose preparation and administration carefully, in order to ensure that the correct dose is administered.
Slovenian: Točno upoštevajte navodila, dana spodaj, za pripravo in dajanje odmerka, da se zagotovi dajanje pravega odmerka.
English: Push the plunger inside the oral syringe fully down.
Slovenian: Pritisnite bat do konca navzdol v brizgo za peroralno dajanje.
English: The bottle should be shaken vigourously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed (Figure A).
Slovenian: Steklenico je treba najmanj 20 sekund močno stresati (slika A), dokler se trdna pogača na dnu steklenice povsem ne razpusti.
English: 5-ml oral syringe (0.2 ml graduation)
Slovenian: 5-ml brizga za peroralno dajanje (graduira na po 0,2 ml)
English: - The other ingredients are hydroxypropylmethylcellulose, glycerol (see section 2), polysorbate 80, sodium benzoate (E211) (see section 2), citric acid monohydrate, sodium citrate (see section 2), strawberry aroma (artificial) and purified water.
Slovenian: 80, natrijev benzoat (E211) (glejte poglavje 2), citronska kislina monohidrat, natrijev citrat
English: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP3A4-mediated metabolism.
Slovenian: Študije in vitro, pri katerih so uporabili človeške mikrosome jeter in s cDNA izražene encime P450,
English: Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9.
Slovenian: zato lahko zdravljenje z nitizinonom povzroči zvišane plazemske koncentracije sočasno dajanih zdravil, ki se presnavljajo predvsem preko encima CYP 2C9 (glejte poglavje 4.4).
English: No formal food interactions studies have been performed with Orfadin hard capsules.
Slovenian: Formalnih študij interakcij zdravila Orfadin trde kapsule s hrano niso opravili, vendar so med zbiranjem podatkov o učinkovitosti in varnosti nitizinon dajali skupaj s hrano.
English: After first opening, the medicine can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Slovenian: Po prvem odprtju lahko zdravilo shranjujete največ 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
English: The bottle should be kept in an upright position and the oral syringe inserted firmly into the hole of the adaptor, at the top of the bottle (Figure E).
Slovenian: Steklenico je treba držati v pokončnem položaju in brizgo za peroralno dajanje čvrsto vstaviti v odprtino na nastavku na vrhu steklenice (slika E).
English: The oral syringes are graduated in 0.01 ml, 0.1 ml and 0.2 ml steps respectively.
Slovenian: Brizge za peroralno dajanje so graduirane v stopnjah po 0,01 ml, 0,1 ml in 0,2 ml. Spodnja preglednica prikazuje pretvorbo odmerka (mg/ml) za tri velikosti brizg za peroralno dajanje.
English: Talk to your doctor or pharmacist before taking Orfadin.
Slovenian: Pred začetkom jemanja zdravila Orfadin se posvetujte z zdravnikom ali farmacevtom.
English: 1-ml oral syringe (0.01 ml graduation)
Slovenian: 1-ml brizga za peroralno dajanje (graduira na po 0,01 ml)
English: Your liver will be checked at regular intervals because the disease affects the liver.
Slovenian: Ker bolezen prizadene jetra, vam bodo v intervalih opravili redne preglede jeter.
English: Orfadin 5 mg: Each capsule contains 5 mg nitisinone.
Slovenian: Orfadin 5 mg: Ena kapsula vsebuje 5 mg nitizinona.
English: Therefore, it is recommended that if nitisinone treatment with Orfadin hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2.
Slovenian: Če se zdravljenje z nitizinonom z zdravilom Orfadin trde kapsule začne ob hrani, se priporoča, da se to vzdržuje rutinsko,
English: Orfadin 20 mg: Each capsule contains 20 mg nitisinone.
Slovenian: Orfadin 20 mg: Ena kapsula vsebuje 20 mg nitizinona.
English: Figure C.
Slovenian: Slika C
English: Capsule shell: gelatine titanium dioxide (E 171).
Slovenian: - Druge sestavine zdravila so: Vsebina kapsule: predgeliran (koruzni) škrob Ovojnica kapsule: želatina titanov dioksid (E 171)
English: 1 ml contains 4 mg nitisinone.
Slovenian: 1 ml vsebuje 4 mg nitizinona.
English: After first opening, the in-use stability is a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Slovenian: 2 leti Po prvem odprtju je zdravilo fizikalno stabilno 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
English: 3-ml oral syringe (0.1 ml graduation)
Slovenian: 3-ml brizga za peroraln o dajanje (graduir ana po 0,1 ml)
English: Figure D.
Slovenian: Slika D
English: The bottle should be turned carefully upside down with the oral syringe in place (Figure F).
Slovenian: Steklenico je treba z nameščeno brizgo za peroralno dajanje obrniti navzdol (slika F).
English: Orfadin 2 mg: Each capsule contains 2 mg nitisinone.
Slovenian: Orfadin 2 mg: Ena kapsula vsebuje 2 mg nitizinona.
English: Package leaflet: Information for the user Orfadin 4 mg/ml oral suspension nitisinone
Slovenian: Navodilo za uporabo Orfadin 4 mg/ml peroralna suspenzija nitizinon
English: Orfadin 10 mg: Each capsule contains 10 mg nitisinone.
Slovenian: Orfadin 10 mg: Ena kapsula vsebuje 10 mg nitizinona.
English: If you have the impression that the medicine is not working properly, talk to your doctor.
Slovenian: Če ste prenehali jemati zdravilo Orfadin Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom.
English: Figure E.
Slovenian: Slika E
English: The product can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded.
Slovenian: Zdravilo lahko shranjujete 2 meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH
English: Each ml contains 4 mg nitisinone.
Slovenian: En ml vsebuje 4 mg nitizinona.
English: Each capsule contains 20 mg nitisinone.
Slovenian: Ena kapsula vsebuje 20 mg nitizinona.
English: The hard capsules are white, opaque, imprinted with “NTBC” and the strength “2 mg”, “5 mg”, “10 mg” or “20 mg”, in black.
Slovenian: Kapsule so trde želatinske kapsule motno bele barve, vtisnjen imajo napis »NTBC« in jakost »2 mg«,
English: Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Slovenian: Klinična študija medsebojnega delovanja z nitizinonom 80 mg v stanju dinamičnega ravnovesja je pokazala, da je nitizinon zmerni zaviralec encima CYP 2C9 (2,3−kratno zvišanje AUC tolbutamida),
English: Figure A.
Slovenian: Slika A
English: A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/l.
Slovenian: 500 mikromolov/l, je treba z dieto še bolj zmanjšati vnos tirozina in fenilalanina.
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules nitisinone
Slovenian: Orfadin 2 mg trde kapsule Orfadin 5 mg trde kapsule Orfadin 10 mg trde kapsule Orfadin 20 mg trde kapsule nitizinon peroralna uporaba
English: Replace the child resistant screw cap directly after use.
Slovenian: Takoj po uporabi znova namestite za otroke varno navojno zaporko.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on the body of the capsule.
Slovenian: Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 5mg« na telesu kapsule.
English: The child-resistant screw cap should be replaced directly after use.
Slovenian: Takoj po uporabi je treba znova namestiti za otroke varno navojno zaporko.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VSEBNIKU
English: The plunger inside the oral syringe should be pushed fully down.
Slovenian: Bat je treba do konca pritisniti navzdol v brizgo za peroralno dajanje.
English: Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules
Slovenian: Orfadin 2 mg trde kapsule Orfadin 5 mg trde kapsule Orfadin 10 mg trde kapsule Orfadin 20 mg trde kapsule
English: White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on the body of the capsule.
Slovenian: Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 20mg« na telesu kapsule.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on the body of the capsule.
Slovenian: Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 2mg« na telesu kapsule.
English: White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on the body of the capsule.
Slovenian: Kapsule (6 x 16 mm) motno bele barve s črnim vtisom »NTBC 10mg« na telesu kapsule.
English: All patients Start age months Start age months
Slovenian: Začetna starost ≤ 24 mesecev
English: Three oral syringes (1 ml, 3 ml and 5 ml) are provided for accurate measurement of the prescribed dose.
Slovenian: Za natančno merjenje predpisanega omerka so priložene tri brizge za peroralno dajanje (1 ml,
English: - Keep this leaflet.
Slovenian: Shranjujte v pokončnem položaju.
English: 4 x 1 capsules (unit dose)
Slovenian: 4 x 1 kapsula (za enkraten odmerek)
English: Further information on Lumark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Lumark so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lumark received a marketing authorisation valid throughout the EU on 19 June 2015.
Slovenian: Za zdravilo Lumark je bilo 19. junija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Lumark?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lumark?
English: Lumark is never given to a patient on its own.
Slovenian: Zdravilo Lumark se bolniku nikoli ne daje samostojno.
English: However, the quantity of Lumark to be used is very small and therefore these risks are considered low.
Slovenian: Vendar pa je količina zdravila Lumark, ki jo je treba uporabiti, zelo majhna, zato je tudi to tveganje majhno.
English: Other information about Lumark
Slovenian: Druge informacije o zdravilu Lumark
English: The most common side effects with Lumark (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Slovenian: Najpogostejši neželeni učinki zdravila Lumark (ki se lahko pojavijo pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), trombocitopenija (nizko število trombocitov), levkopenija (nizko število belih krvnih celic), limfopenija (nizko število limfocitov, posebne vrste belih krvnih celic), navzeja (slabost), bruhanje in blago, začasno izpadanje las.
English: These tumours affect hormone-secreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Slovenian: Ti tumorji prizadenejo celice, ki izločajo hormone, v številnih delih telesa, vključno s trebušno slinavko, črevesjem, želodcem in pljuči.
English: The doctor will ensure that the expected benefit to the patients of using Lumark outweigh the risks linked to the radioactivity.
Slovenian: Zdravnik bo zagotovil, da bodo pričakovane koristi uporabe zdravila Lumark za bolnike večje od tveganj, povezanih z radioaktivnostjo.
English: Why is Lumark authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Lumark odobreno v EU?
English: The Agency concluded that the benefits of Lumark outweigh the risks and it can be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Lumark večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What benefits of Lumark have been shown in studies?
Slovenian: Kakšne koristi zdravila Lumark so se pokazale v študijah?
English: What is Lumark and what is it used for?
Slovenian: Kaj je zdravilo Lumark in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lumark have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lumark upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Lumark are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Lumark, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Radiolabelling with Lumark takes place in a laboratory.
Slovenian: Radiooznačevanje z zdravilom Lumark poteka v laboratoriju.
English: An overview of Lumark and why it is authorised in the EU
Slovenian: Pregled zdravila Lumark in zakaj je odobreno v EU
English: When a medicine is radiolabelled with Lumark, the medicine carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Slovenian: Ko je zdravilo radiooznačeno z zdravilom Lumark, prenese sevanje v tiste dele telesa, v katerih je potrebno, da uniči rakave celice (kadar se uporablja za zdravljenje) ali da se pridobijo slike na zaslonu (kadar se uporablja za diagnostične namene).
English: Lumark is only used by specialists who have experience in radiolabelling.
Slovenian: Zdravilo Lumark smejo uporabljati samo specialisti, ki imajo izkušnje z radiooznačevanjem.