natgillin/translations-raw huggingface dataset:
Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0, 25 mg prašek za koncentrat za raztopino za infundiranje trabektedin
Also contains: sucrose, potassium dihydrogen phosphate, phosphoric acid and potassium hydroxide.
Vsebuje tudi: saharozo, kalijev dihidrogefosfat, fosforno kislino in kalijev hidroksid.
Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
1 viala z 0, 25 mg trabektedina
For storage conditions for the reconstituted and diluted solutions, see the package leaflet.
Za pogoje shranjevanja rekonstituirane in razredčene raztopine glejte navodila za uporabo.
Cytotoxic product.
Citotoksično zdravilo.
La Mina 28770 Colmenar Viejo (Madrid) Spain
La Mina 28770 Colmenar Viejo (Madrid) Španija
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Vial label – 0.25 mg vial
Nalepka na viali – 0, 25 mg viala
Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin IV use
Yondelis 0, 25 mg prašek za koncentrat za raztopino za infundiranje trabektedin i. v. uporaba
0.25 mg trabectedin
0, 25 mg trabektedina
Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje trabektedin
Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
1 viala z 1 mg trabektedina
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
37 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin IV use
Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje trabektedin i. v. uporaba
Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Yondelis 0, 25 mg prašek za koncentrat za raztopino za infundiranje Yondelis 1 mg prašek za koncentrat za raztopino za infundiranje trabektedin
What Yondelis is and what it is used for 2.
Kaj je zdravilo Yondelis in za kaj ga uporabljamo 2.
Before you are given Yondelis 3.
Kaj morate vedeti, preden boste uporabili zdravilo Yondelis 3.
How to use Yondelis 4.
Kako uporabljati zdravilo Yondelis 4.
How to store Yondelis 6.
Shranjevanje zdravila Yondelis 6.
WHAT YONDELIS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO YONDELIS IN ZA KAJ GA UPORABLJAMO
Yondelis is an anti-cancer medicine that works by preventing the tumour cells from multiplying.
Yondelis je zdravilo proti raku, ki deluje tako, da preprečuje razmnoževanje celic tumorja.
Yondelis is used for the treatment of patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful or the patients are unsuited to receive them.
Zdravilo Yondelis se uporablja za zdravljenje bolnikov z napredovanim sarkomom mehkega tkiva, če prejšnja zdravila niso učinkovala, ali če za bolnika njihova uporaba ni primerna.
BEFORE YOU ARE GIVEN YONDELIS
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO YONDELIS
Do not use Yondelis:
Ne uporabljajte zdravila Yondelis:
- if you are allergic (hypersensitive) to trabectedin or any of the other ingredients of Yondelis
- če ste alergični na (preobčutljivi za) trabektedin ali katerokoli sestavino zdravila Yondelis
- if you have any serious infections
- če imate resne okužbe
Take special care with Yondelis:
Bodite posebno pozorni pri uporabi zdravila Yondelis:
Yondelis must not be used if you have severe liver or kidney damage.
Zdravila Yondelis ne smete uporabljati, če imate resno poškodovana jetra ali ledvice.
Tell your doctor if you know or suspect that you have any liver or kidney problems before starting the treatment with Yondelis.
Pred začetkom zdravljenja z zdravilom Yondelis zdravnika obvestite, če veste ali sumite, da imate težave z jetri ali ledvicami.
• If you develop a fever as Yondelis may cause side-effects affecting your blood and liver.
• Če se pojavi zvišana telesna temperature, saj lahko zdravilo Yondelis povzroči neželene učinke, ki vplivajo na vašo kri in jetra.
40 • If you experience severe muscle pain as it could be a sign of rhabdomyolysis (damage to the muscles, see section 4).
40 • Če izkusite resne bolečine mišic, saj bi lahko to bil znak rabdomiolize (poškodba mišic, glejte poglavje 4).
Yondelis must not be used in children and adolescents since safety and efficacy have not yet been studied in this age group.
Zdravila Yondelis ni dovoljeno uporabljati pri otrocih in mladostnikih, saj varnosti in učinkovitosti v tej starostni skupini niso raziskali.
Please tell your doctor if you plan to take, are taking or have recently taken any other medicines, including medicines obtained without a prescription, vaccines and herbal medicines.
Obvestite svojega zdravnika, če načrtujete uporabo, jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, bili cepljeni ali ste jemali zdravila rastlinskega izvora.
If you use other medicines, you may need to be closely monitored as the effects of Yondelis might be decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John´s Wort (Hypericum perforatum, herbal medicine for depression)) or increased (examples are medicines containing ketoconazole or fluconazole (for fungal infections), ritonavir (for HIV infection), clarithromycin (for bacterial infections), ciclosporin (inhibit the defensive system of the body) or verapamil (for high blood pressure and heart conditions)) as a result.
Če uporabljate druga zdravila, vas bo morda treba bolj skrbno nadzirati, saj se lahko učinki zdravila Yondelis zmanjšajo (primeri so zdravila, ki vsebujejo rifampicin (za bakterijske okužbe), fenobarbital (za epilepsijo) ali šentjanževko (Hypericum perforatum, zdravilo rastlinskega izvora za depresijo)) ali povečajo (primeri so zdravila, ki vsebujejo ketokonazol ali flukonazol (za glivične okužbe), ritonavir (za okužbe s HIV), klaritromicin (za bakterijske okužbe), ciklosporin (zavira obrambni sistem telesa) ali verapamil (za visok pritisk in bolezni srca)).
If you are given a medicine that might cause damage to the liver or to the muscles (rhabdomyolysis), you may need to be closely monitored when using Yondelis together with this medicine, as there could be an increased risk of damage.
Če prejemate zdravilo, ki lahko povzroči poškodbe jeter ali mišic (rabdomioliza), vas bo morda treba skrbno nadzirati pri uporabi zdravila Yondelis skupaj s temi zdravili, saj je tveganje poškodb večje.
Medicines containing statins (for lowering cholesterol levels and preventing cardiovascular disease) is an example of medicines that may cause muscle damage.
Zdravila, ki vsebujejo statine (za nižanje ravni holesterola in preprečevanje kardiovaskularnih bolezni) so primer zdravil, ki lahko povzročijo poškodbo mišic.
Using Yondelis with food and drink
Uporaba zdravila Yondelis skupaj s hrano in pijačo
Pregnancy You should not use Yondelis if you are pregnant or if you/ your partner are trying to become pregnant as Yondelis may harm the unborn baby.
Nosečnost Zdravila Yondelis ne uporabljajte, če ste noseči ali če želite vi/ vaš partner zanositi, saj lahko zdravilo Yondelis poškoduje nerojenega otroka.
If you are pregnant or you think you may be pregnant, you must tell your doctor immediately.
Če ste noseči ali mislite, da ste morda noseči, nemudoma obvestite svojega zdravnika.
The doctor may prescribe Yondelis during pregnancy in certain circumstances.
V določenih okoliščinah vam lahko zdravnik predpiše zdravilo Yondelis tudi med nosečnostjo.
Adequate contraceptive precautions must be used by men in fertile age and women of childbearing potential when receiving Yondelis and for 3 months following the end of treatment for women and 5 months following the end of treatment for men.
Moški v plodni dobi in plodne ženske naj med uporabo zdravila Yondelis uporabljajo učinkovito zaščito pred zanositvijo, ženske še 3 mesece po zdravljenju in moški še 5 mesecev po zdravljenju.
If a pregnancy should occur you must tell your doctor immediately and genetic counselling is recommended since Yondelis can cause genetic damage.
Priporoča se gensko svetovanje, saj lahko zdravilo Yondelis povzroči genske poškodbe.
Male patients should seek advice on conservation of sperm prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Pred zdravljenjem se je treba posvetovati o konzervaciji sperme zaradi možnosti nepopravljive neplodnosti zaradi zdravljenja z zdravilom Yondelis.
Breast-feeding Yondelis must not be given to patients who are breast-feeding.
Dojenje Doječim bolnica se ne sme dajati zdravila Yondelis.
41 During your treatment with Yondelis you may feel tired and experience a loss of strength.
Med zdravljenjem z zdravilom Yondelis boste morda utrujeni in se počutili šibke.
Important information about some of the ingredients of Yondelis
41 Pomembne informacije o nekaterih sestavinah zdravila Yondelis
This medicine contains potassium, less than 1 mmol (39 mg) per vial, and can therefore be considered as essentially “ potassium-free”.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na vialo, kar v bistvu pomeni „ brez kalija “.
HOW TO USE YONDELIS
KAKO UPORABLJATI ZDRAVILO YONDELIS
The usual dose is 1.5 mg/ m2 of body surface area.
Običajni odmerek je 1, 5 mg/ m2 površine telesa.
Before it is given to you, Yondelis is reconstituted and diluted for intravenous use.
Preden boste zdravilo Yondelis prejeli, bo rekonstituirano in razredčeno za intravensko uporabo.
Every time you are given Yondelis, it will take about 24 hours for all of the solution to enter your blood.
Vsakič, ko prejmete zdravilo Yondelis, bo trajalo okoli 24 ur, da vsa raztopina vstopi v vašo kri.
You will be given medicine before and as needed during the treatment with Yondelis in order to protect your liver and to reduce the risk of side effects such as feeling sick (nausea) and vomiting.
Pred in po zdravljenju z zdravilom Yondelis boste prejeli zdravila, ki bodo ščitila vaša jetra in zmanjšala tveganje neželenih učinkov, kot je slabost (navzea) in bruhanje.
The infusion is given to you every 3 weeks.
Infuzijo boste prejeli vsake 3 tedne.
Your doctor will tell you how long your treatment may last.
Zdravnik vam bo povedal, kako dolgo lahko zdravljenje traja.
Like all medicines, Yondelis can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Yondelis neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common (occurring in at least 1 in 10 patients):
Zelo pogosti (pojavijo se pri vsaj 1 od 10 bolnikov):
• You may: • feel tired • feel short of breath (dyspnoea) • bruise more easily • have nose bleeds • be more prone to infections.
• Lahko: • se počutite utrujeno • imate kratko sapo (dispneja) • hitro dobite modrice • krvavite iz nosu • ste bolj nagnjeni k okužbam.
An infection could also give you a raised temperature.
Okužba je lahko tudi vzrok zvišane telesne temperature.
• Your doctor may require blood tests in certain situations in order to avoid that you develop damage to the muscles (rhabdomyolysis).
• Zdravnik lahko v nekaterih okoliščinah zahteva izvedbo krvnih testov, da prepreči nastanek poškodb mišic (rabdomioliza).
If you experience severe muscle pain, you should seek medical attention immediately.
Če izkusite resne bolečine v mišicah, morate nemudoma poiskati zdravniško pomoč.
42 • You may experience headache and a loss of strength.
• Lahko se pojavi glavobol in izguba moči.
• You may also lose your appetite, feel sick (nausea) or vomit, and become constipated.
42 • Pojavi se lahko tudi izguba teka, občutek slabosti (navzea) ali bruhanje in zaprtost.
If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medication, you should immediately seek medical help.
Če vam je slabo, bruhate ali ne morete piti tekočine in zato izločate manj urina, kljub temu, da ste prejeli zdravilo proti slabosti, morate nemudoma poiskati zdravniško pomoč.
Common (occurring in at least 1 in 100 patients):
Pogosti (pojavijo se pri vsaj 1 od 100 bolnikov):
• You may have fever.
• Imate lahko zvišano telesno temperaturo.
• You could also feel pain in your back, muscles and joints.
• Čutite lahko tudi bolečine v hrbtu, mišicah in sklepih.
• You may experience diarrhoea, loss of water from the body, inflammation of the mouth (stomatitis), pain in the abdomen, weight loss, digestive discomfort and a change in your sense of taste.
• Morda boste imeli drisko, izgubljali vodo iz telesa, vnetje ust (stomatitis), bolečine v trebuhu, izgubljali telesno maso, imeli težave s prebavo in spremenjen občutek za okus.
• You could have coughing.
• Pojavi se lahko kašelj.
• You could also experience dizziness, sleeping problems, low blood pressure and flushing.
• Lahko se pojavi vrtoglavica, težave s spanjem, nizek krvni pritisk in oblivanje.
• You may have a reaction at the site of injection
• Lahko se pojavijo reakcije na mestu injiciranja
HOW TO STORE YONDELIS
SHRANJEVANJE ZDRAVILA YONDELIS
Do not use Yondelis after the expiry date which is stated on the carton and the vial label after EXP.
Zdravila Yondelis ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na ovojnini viale za oznako EXP.
What Yondelis contains:
Kaj vsebuje zdravilo Yondelis:
- The active substance is trabectedin.
- Zdravilna učinkovina je trabektedin.
Each vial contains 0.25 mg of trabectedin Yondelis 1 mg:
Viala vsebuje 0, 25 mg trabektedina Yondelis 1 mg:
- The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for
- Pomožne snovi so saharoza, kalijev dihidrogenfosfat, fosforna kislina (za prilagoditev pH) in
pH-adjustment) and potassium hydroxide (for pH-adjustment).
kalijev hidroksid (za prilagoditev pH).
43 What Yondelis looks like and contents of the pack
43 Izgled zdravila Yondelis in vsebina pakiranja
Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Ena škatla vsebuje 1 vialo s po 0, 25 mg ali 1 mg trabektedina.
Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Avda. de los Reyes 1 Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Španija
This medicine has been authorised under “ Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v „ izjemnih okoliščinah “.
You should have received training on the correct techniques to reconstitute and dilute Yondelis and you should wear protective clothing including mask, goggles and gloves during the reconstitution and dilution.
Med rekonstituiranjem in redčenjem vedno nosite zaščitna oblačila vključno z masko, očali in rokavicami.
Preparation for intravenous infusion:
Priprava intravenske infuzije:
Yondelis must not be administered as a mixture with other medicines in the same infusion apart from the diluent.
Zdravila Yondelis ni dovoljeno dajati kot mešanice z drugimi zdravili v isti infuziji, razen z topilom.
Instructions for reconstitution:
Navodila za rekonstituiranje:
Yondelis 0.25 mg:
Zdravilo Yondelis 0, 25 mg:
Inject 5 ml of sterile water for injections into the vial.
Injicirajte 5 ml sterilne vode za injekcije v viale.
44 Yondelis 1 mg:
44 Zdravilo Yondelis 1 mg:
Inject 20 ml of sterile water for injections into the vial.
Injicirajte 20 ml sterilne vode za injekcije v viale.
Instructions for dilution:
Navodila za redčenje:
Dilute the reconstituted solution with sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion.
Rekonstituirano raztopino razredčite z natrijevim kloridom 9 mg/ ml (0, 9%) raztopino za infundiranje ali glukozo 50 mg/ ml (5%) raztopino za infundiranje.
BSA = Body Surface Area
Volumen (ml) = PT (m2) x individualni odmerek (mg/ m2) 0, 05 mg/ ml
If administration is to be made via a central venous line, add the reconstituted solution to an infusion bag containing ≥ 50 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion), being the concentration of trabectedin in the infusion solution ≤ 0.030 mg/ ml.
Če bo dajanje potekalo prek centralne venske linije, dodajte rekonstituirano raztopino v infuzijsko vrečko, ki vsebuje ≥ 50 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje ali glukoza 50 mg/ ml (5%) raztopina za infundiranje), pri čemer je koncentracija trabektedina v raztopini za infundiranje ≤ 0, 030 mg/ ml.
If central venous access is not feasible and a peripheral venous line has to be used, add the reconstituted solution to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose 50 mg/ ml (5%) solution for infusion).
Če dostop prek centralno veno ni možen in je treba uporabiti periferno vensko linijo, je treba rekonstituirano raztopino dodati v vrečko za infundiranje, ki vsebuje ≥ 1. 000 ml topila (natrijev klorid 9 mg/ ml (0, 9%) raztopina za infundiranje ali glukoza 50 mg/ ml (5%) raztopina za infundiranje).
Inspect the parenteral solution visually for particles prior to administration.
Parenteralne raztopine je treba pred dajanjem vizualno pregledati za delce.
In-use stability of the solutions:
Stabilnost raztopine med uporabo:
Reconstituted solution:
Rekonstitutirana raztopina:
If not diluted and used immediately, in-use storage times and conditions prior to use of the reconstituted solution are the responsibility of the user and would normally not be longer than 24 hours at 2ºC to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če se rekonstituirana raztopina ne razredči in porabi takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
90Y, yttrium-90, is a radioactive form of the chemical element yttrium.
90Y, itrij- 90, je radioaktivna oblika kemijskega elementa itrija.
As Ytracis is a ‘ precursor’ and will not be given on its own, no studies have been done in humans.
Kakšne koristi je zdravilo Ytracis izkazalo med raziskavami?
The company also presented published information supporting the use of 90Y in radiolabelling other medicines.
Podatki, ki jih je priskrbelo podjetje, podpirajo uporabo zdravila Ytracis kot „ predhodnika “ za radioaktivno označevanje zdravil z 90Y.
What benefit has Ytracis shown during the studies?
Kakšna tveganja so povezana z zdravilom Ytracis?
The information supplied by the company supports the use of Ytracis as a precursor for radiolabelling medicines with 90Y.
Ker je zdravilo Ytracis "predhodnik" in se ne uporablja samostojno, nima neželenih stranskih učinkov.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ytracis’ s benefits are greater than its risks for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ytracis pri radioaktivnem označevanju nosilnih molekul, ki so bile posebej razvite in odobrene za radioaktivno označevanje s tem radionuklidom, večje od z njim povezanih tveganj.
Package size
Vsebina (koncentracija) Velikost pakiranje
1ml of sterile solution contains 1.850 GBq Yttrium (90Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium.
1 ml sterilne raztopine vsebuje 1, 850 GBq itrijevega (90Y) klorida na dan kalibracije, kar odgovarja 92 ng itrija.
One vial contains 0.925 to 3.700 GBq (see section 6.5).
Ena viala vsebuje 0, 925 do 3, 700 GBq (glejte poglavje 6. 5).
Refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Upoštevajte Povzetek glavnih značilnosti zdravila/ navodilo za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
- Hypersensitivity to the the active substance or to any of the excipients.
- preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Za informacije o kontraindikacijah za določena z itrijem (90Y) označena zdravila, ki so pripravljena z uporabo YTRACISa, upoštevajte Povzetek glavnih značilnosti zdravila/ navodilo za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
For information concerning special warnings and precautions for use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Informacije o posebnih opozorilih in previdnostnih ukrepih glede uporabe z itrijem (90Y) označenih zdravil najdete v Povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
No interaction studies have been performed..
Študij medsebojnega delovanja niso izvedli.
For information concerning interactions associated with the use of Yttrium (90Y)-labelled medicinal products refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Informacije o interakcijah povezanih z uporabo z itrijem (90Y) označenih zdravil najdete v Povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
YTRACIS is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3 Contraindications).
YTRACIS je kontraindiciran v primeru ugotovljene nosečnosti ali suma na nosečnost ali v primeru, da se nosečnosti ne more izključiti (glejte poglavje 4. 3 Kontraindikacije).
The absorbed dose to the uterus following administration of Yttrium (90Y)-labelled medicinal products is dependent on the specific medicinal product being radiolabelled and is to be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Absorbirana doza sevanja za maternico po aplikaciji z itrijem (90Y) označenega zdravila je odvisna od posameznega zdravila, ki se označuje, in mora biti navedena v Povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
Before administering a radioactive medicinal product to a mother who is breast-feeding, consideration should be given to whether the administration could be reasonably delayed until the mother has ceased breastfeeding.
3 Pred aplikacijo radiofarmaka doječi materi moramo pretehtati, če se aplikacije morda ne bi dalo razumno odložiti, dokler mati ne preneha z dojenjem.
For information concerning the use of Yttrium (90Y)-labelled medicinal products in pregnancy and lactation refer to the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Informacije o uporabi z itrijem (90Y) označenih zdravil med nosečnostjo in dojenjem najdete v Povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
3 4.7 Effects on ability to drive or use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Effects on ability to drive or use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/ package leaflet of the particular medicinal product to be radiolabelled.
Za informacije o kontraindikacijah za določena z itrijem (90Y) označena zdravila, ki so pripravljena z uporabo YTRACISa, upoštevajte Povzetek glavnih značilnosti zdravila/ navodilo za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.
Such information will be supplied in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Informacije o tem najdete v Povzetku glavnih značilnosti zdravila/ navodilu za uporabo zdravila, ki naj bi ga označili z radioaktivnim izotopom.