natgillin/translations-raw huggingface dataset:
You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium 
dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki)
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Laktoza: Bolniki z redko dedno intoleranco za galaktozo, popolno odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The demonstration of renal benefit of Karvea in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). 
Koristi zdravljenja z zdravilom Karvea za ledvice pri bolnikih z visokim krvnim tlakom z diabetesom tipa 2 so pokazale študije, kjer so irbesartan uporabljali dodatno z drugimi antihipertenzivi, potrebnimi za doseganje ciljnega krvnega tlaka (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
Karvea should not be given to children under 18 years of age. 
Otroci in mladostniki, mlajši od 18 let, zdravila Karvea ne smejo jemati.
Each tablet of Karvea 75 mg contains 75 mg irbesartan. 
Ena tableta zdravila Karvea 75 mg vsebuje 75 mg irbesartana.
Karvea is unlikely to affect your ability to drive or use machines. 
Verjetnost, da bi zdravilo Karvea vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
Karvea 300 mg tablets irbesartan 
Karvea 300 mg tablete irbesartan
Each tablet of Karvea 300 mg contains 300 mg irbesartan. 
Ena tableta zdravila Karvea 300 mg vsebuje 300 mg irbesartana.
Each tablet of Karvea 150 mg contains 150 mg irbesartan. 
Ena tableta zdravila Karvea 150 mg vsebuje 150 mg irbesartana.
Warnings and precautions Talk to your doctor before taking Karvea and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Karvea for diabetic kidney disease. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Karvea se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenegače začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Karvea jemljete zaradi diabetične bolezni ledvic.
Karvea 75 mg film-coated tablets irbesartan 
Karvea 75 mg filmsko obložene tablete irbesartan
Karvea with food and drink Karvea can be taken with or without food. 
Jemanje zdravila Karvea skupaj s hrano in pijačo
How to store Karvea 
Shranjevanje zdravila Karvea
Because no information is available regarding the use of Karvea during breast-feeding, Karvea is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
Podatkov o uporabi zdravila Karvea med dojenjem ni na voljo, zato uporaba zdravila Karvea med dojenjem ni priporočljiva.
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose). 
11,7 mmHg (nizki odmerek), 9,3 mmHg (srednji odmerek) oz. 13,2 mmHg (visoki odmerek).
Vistor hf. 
Po peroralnem ali i.v.
Metabolism and nutrition disorders 
Motnje reprodukcije in dojk
Warning and precautions Talk to your doctor before taking Karvea and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Karvea for diabetic kidney disease. 
Pred začetkom jemanja zdravila Karvea se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega če začnete prekomerno bruhati ali dobite hudo drisko če imate težave z ledvicami če imate težave s srcem če zdravilo Karvea jemljete zaradi diabetične bolezni ledvic.
Karvea is used in adult patients to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function. 
za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females). 
IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30
Karvea 150 mg film-coated tablets irbesartan 
Karvea 150 mg filmsko obložene tablete irbesartan
Karvea 300 mg film-coated tablets irbesartan 
Karvea 300 mg filmsko obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Karvea 75 mg film-coated tablets. 
Karvea 75 mg filmsko obložene tablete.
Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Some undesirable effects have been reported since marketing of Karvea. 
Po prihodu zdravila Karvea na tržišče so poročali še o nekaterih drugih neželenih učinkih.
Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. 
Karvea 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets. 
Karvea 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
Package leaflet: Information for the user Karvea 75 mg tablets irbesartan 
Navodilo za uporabo Karvea 75 mg tablete irbesartan
What Karvea looks like and contents of the pack Karvea 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side. 
Karvea 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
NAME OF THE MEDICINAL PRODUCT Karvea 150 mg film-coated tablets. 
Karvea 150 mg filmsko obložene tablete.
What Karvea contains  The active substance is irbesartan. 
Zdravilna učinkovina je irbesartan.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. 
V tem primeru bo zdravnik morda moral redno opravljati krvne preiskave, še posebej tiste, s katerimi bo v primeru slabega delovanja ledvic spremljal vrednosti kalija v krvi.
Package leaflet: Information for the user Karvea 75 mg film-coated tablets irbesartan 
Navodilo za uporabo Karvea 75 mg filmsko obložene tablete irbesartan
EU/1/97/049/011 - 14 tablets EU/1/97/049/004 - 28 tablets EU/1/97/049/005 - 56 tablets EU/1/97/049/014 - 56 x 1 tablets EU/1/97/049/006 - 98 tablets 
EU/1/97/049/014 - 56 x 1 tableta EU/1/97/049/006 - 98 tablet
EU/1/97/049/012 - 14 tablets EU/1/97/049/007 - 28 tablets EU/1/97/049/008 - 56 tablets EU/1/97/049/015 - 56 x 1 tablets EU/1/97/049/009 - 98 tablets 
EU/1/97/049/015 - 56 x 1 tableta EU/1/97/049/009 - 98 tablet
Package leaflet: Information for the user Karvea 150 mg tablets irbesartan 
Navodilo za uporabo Karvea 150 mg tablete irbesartan
orthostatic hypotension* Uncommon: flushing Respiratory, thoracic and mediastinal disorders Uncommon: cough 
hepatitis, motnje v delovanju jeter Bolezni kože in podkožja: Neznana:
NAME OF THE MEDICINAL PRODUCT Karvea 300 mg film-coated tablets. 
Karvea 300 mg filmsko obložene tablete.
EU/1/97/049/010 - 14 tablets EU/1/97/049/001 - 28 tablets EU/1/97/049/002 - 56 tablets EU/1/97/049/013 - 56 x 1 tablets EU/1/97/049/003 - 98 tablets 
EU/1/97/049/013 - 56 x 1 tableta EU/1/97/049/003 - 98 tablet
Package leaflet: Information for the user Karvea 150 mg film-coated tablets irbesartan 
Navodilo za uporabo Karvea 150 mg filmsko obložene tablete irbesartan
What Karvea looks like and contents of the pack Karvea 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side. 
Karvea 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
Package leaflet: Information for the user Karvea 300 mg tablets irbesartan 
Navodilo za uporabo Karvea 300 mg tablete irbesartan
Check with your doctor or pharmacist if you are not sure. 
Če opazite katerikoli neželeni učinek se posvetujte z zdravnikom ali s farmacevtomPosvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu
What Karvea looks like and contents of the pack Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. 
Karvea 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
Package leaflet: Information for the user Karvea 300 mg film-coated tablets irbesartan 
Navodilo za uporabo Karvea 300 mg filmsko obložene tablete irbesartan
EU/1/97/049/021 - 14 tablets EU/1/97/049/022 - 28 tablets EU/1/97/049/035 - 30 tablets EU/1/97/049/023 - 56 tablets EU/1/97/049/024 - 56 x 1 tablets EU/1/97/049/032 - 84 tablets EU/1/97/049/038 - 90 tablets EU/1/97/049/025 - 98 tablets 
EU/1/97/049/024 - 56 x 1 tableta EU/1/97/049/032 - 84 tablet
This should be taken into consideration when using the following information: 
To je treba upoštevati tudi pri uporabi naslednjih podatkov:
MARKETING AUTHORISATION NUMBER EU/1/97/057/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/97/057/001
Such reactions are usually responsive to analgesics. 
Take reakcije se običajno odzivajo na analgetike.
He will decide at which time you will be authorised to leave the nuclear medicine department. 
Zdravnik bo odločil, kdaj vam bo dovoljeno oditi z oddelka za nuklearno medicino.
Date of latest renewal: 12 December 2007 
Datum zadnjega podaljšanja: 12. december 2007
This effect is moderate and brief and will disappear after some hours. 
Ta učinek je zmeren in kratkotrajen in po nekaj urah izgine.
It should be clear without particles. 
Biti mora bistra, brez delcev.
Relief of pain may persist for 4 weeks up to 4 months. 
Olajšanje bolečine traja 4 tedne do 4 mesece.
The leaflet was last revised in {MM/YYYY} 
Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
• in pregnant women (See section 4.6). 
• pri nosečnicah (glejte poglavje 4.6)
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself. 
V vseh primerih moramo zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 05 February 1998 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 5. februar 1998
(See section 12, for detailed instructions of product preparation) 
(Glejte poglavje 12, kjer so natančna navodila za pripravo zdravila)
You should not be alarmed at this; in such case, your pain medicine will be slightly increased. 
To naj vas ne vznemirja; v takem primeru vam bodo nekoliko povečali odmerek vašega zdravila proti bolečinam.
Cases of bleeding have been reported, some of which have been serious. 
Poročali so o primerih krvavitev, tudi resnejših.
After thawing, do not freeze again. 
Po odmrznjenju ne smete ponovno zamrzovati.
(12 h CET) 
(12 h po srednjeevropskem času)
Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5 %). 
Izločanje z urinom je potekalo pretežno v prvih 4 urah (30,3 ± 13,5 %).
BATCH NUMBER Batch : 
ŠTEVILKA SERIJE Batch:
For instructions on preparation of the medicinal product before administration, see section 12. 
Za navodila glede priprave zdravila pred dajanjem glejte poglavje 12.
Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics. 
Bolnike, ki zaznajo zmanjšanje bolečine, lahko vzpodbudimo k zmanjšanju uporabe opioidnih analgetikov.
Women of childbearing potential have to use effective contraception during the treatment and the whole period of follow-up. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in celotnem kontrolnem obdobju.
At 4 and 24 hours, plasma radioactivity had decreased from 1.3 ± 0.7 % to 0.05 ± 0.03 %. 
Po 4 in 24 urah je radioaktivnost v plazmi padla od 1,3 ± 0,7 % na 0,05 ± 0,03 %.
GBq/vial, 
GBq/viala,
In patients, Quadramet is rapidly cleared from the blood. 
Pri bolnikih se Quadramet hitro izloči iz krvi.
A positive correlation was found between skeletal uptake and the number of metastatic sites. 
Ugotovljena je bila pozitivna korelacija med kopičenjem v skeletu in številom metastatskih mest.
Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations. 
Prevzem, shranjevanje, uporaba, premeščanje in odlaganje radiofarmakov mora potekati v skladu s predpisi in ustreznimi dovoljenji odgovornih lokalnih uradnih organizacij.
These effects were deemed to be related to the progression of the disease. 
Ti učinki so bili po mnenju poročevalcev povezani z napredovanjem bolezni.
In the absence of compatibility studies, this medicinal product must not be mixed with the other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Repeat administration of Quadramet should be based on an individual patient's response to prior treatment and on clinical symptoms. 
Ponovna aplikacija Quadrameta mora temeljiti na odzivu posameznega bolnika na predhodno zdravljenje ter na kliničnih simptomih.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1. dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila..
The administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease. 
Dajanje pa se lahko ponovi 8 tednov po prejemu injekcije, glede na potek vaše bolezni.
Quadramet is contra-indicated (see 4.3) in pregnancy. 
Zdravilo Quadramet je kontraindicirano (glejte poglavje 4.3) med nosečnostjo.
In contrast, skeletal uptake was inversely proportional to plasma radioactivity at 30 minutes. 
Nasprotno pa je bilo kopičenje v skeletu obratno sorazmerno s plazemsko radioaktivnostjo po 30 minutah.
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection). 
Oddelek za nuklearno medicino vam bo dovoljeno zapustiti po opravljeni kontroli sevanja (običajno v 6 urah po prejemu injekcije Quadrameta).
TABLE 2 : RADIATION ABSORBED DOSES 
TABELA 2: ABSORBIRANE DOZE SEVANJA Organ
He/she will be released when exposure rates comply with the limits prescribed by the regulations in force. 
Bolnik/bolnica bo odpuščen, ko bo stopnja izpostavljenosti v mejah, ki jih predpisuje veljavna zakonodaja.
In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours. 
V primeru urinske inkontinence ali urinske zapore vam bodo za 6 ur vstavili urinski kateter.
Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date. 
Bolnišnično osebje bo poskrbelo, da bo zdravilo pravilno shranjeno in da ga ne boste dobili po izteku navedenega roka uporabnosti.
Less urinary excretion occurred in patients who had extensive bony metastases, regardless of the amount of radiopharmaceutical administered. 
Izločanje v urinu je bilo manjše pri bolnikih, ki so imeli obsežne kostne metastaze, ne glede na količino apliciranega radiofarmaka.
No studies have been performed to assess the effect of Quadramet on reproduction. 
Do sedaj niso opravili študij, v katerih bi ocenjevali vpliv Quadrameta na reprodukcijo.
In a carcinogenic potential study of EDTMP, osteosarcomas occurred in rats at high doses. 
V študiji karcinogenega potenciala EDTMP so se pri podganah ob visokih odmerkih pojavili osteosarkomi.
Quadramet must not be administered to pregnant women. 
Quadramet se ne sme dajati nosečnicam.
Excipient with known effect: sodium 8.1 mg/mL. 
Pomožne snovi z znanim učinkom: natrij 8,1 mg/ml.
Manufacturer: CIS bio international. 
Proizvajalec: CIS bio international
The primary radiation emissions of samarium-153 are shown in Table 1. 
Primarne emisije sevanja samarija-153 so navedene v Tabeli 1.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals. 
Upoštevati je treba ustrezne previdnostne ukrepe za zagotavljanje aseptičnosti, ki so v skladu z Dobro proizvodno prakso za zdravila.
In absence of clinical data, the injected activity should be adapted to the renal function. 
Kadar ni na razpolago kliničnih podatkov, moramo injicirano aktivnost prilagoditi delovanju ledvične funkcije.
Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy. 
Vaš zdravnik vam bo tedensko jemal vzorce krvi vsaj 8 tednov zapored, da bi spremljal število trombocitov ter belih in rdečih krvnih telesc, ki lahko zaradi zdravljenja nekoliko upade.
Storage procedures should be in accordance with local regulations for radioactive substances. 
Postopki pri shranjevanju morajo biti v skladu z lokalnimi predpisi za radioaktivne snovi.
Total skeletal uptake of Quadramet in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5 % of the administered activity. 
Skupno kopičenje Quadrameta v raziskavi na 453 bolnikih z različnimi primarnimi malignomi je znašalo 65,5 ± 15,5 % aplicirane radioaktivnosti.
Quadramet is a medicinal product for therapeutic use only. 
Quadramet je zdravilo, namenjeno izključno za terapevtsko uporabo.
The same results were observed for Sm-EDTMP enriched with radiolysis degradants. 
Enake rezultate navajajo za Sm-EDTMP, ki je bil obogaten z razgradnimi produkti radiolize.
Quadramet should be used within 6 hours of thawing. 
Quadramet je treba uporabiti v 6 urah po odmrznjenju.
For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces 17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy. 
Pri aplicirani radioaktivnosti 2590 MBq znaša tipična doza sevanja, ki jo prejme ciljni organ - kostne metastaze 86,5 Gy, tipične doze sevanja, ki jih prejmejo kritični organi, pa so naslednje: normalne kostne površine 17,5 Gy, rdeči kostni mozeg 4,0 Gy, stena sečnega mehurja 2,5 Gy, ledvice 0,047 Gy in jajčniki 0,021 Gy.
During 6 hours following the injection of Quadramet, your physician will encourage you to drink and void as often as possible. 
V šestih urah po injekciji Quadrameta vam bo zdravnik svetoval, da kar se da veliko pijete in pogosto odvajajte vodo.
The estimated absorbed radiation doses to an average adult patient from an intravenous injection of Quadramet are shown in Table 2. 
Ocenjene absorbirane doze sevanja, ki jih prejme povprečen odrasel bolnik po intravenski injekciji zdravila Quadramet, so navedene v tabeli 2.
The clearance of Quadramet being rapid, the precautions relating to the excreted urinary radioactivity need not be taken after 6-12 hours following administration. 
Zaradi hitrega izločanja Quadrameta, previdnostni ukrepi v zvezi z radioaktivnostjo izločenega urina 6-12 ur po aplikaciji niso več potrebni.
For the other patients the urine should be collected for at least six (6) hours. 
Pri ostalih bolnikih pa je treba zbirati urin vsaj šest (6) ur.
The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine. 
Ocenjene vrednosti prejetih doz sevanja temeljijo na študijah klinične porazdelitve s pomočjo metod, ki jih je za izračunavanje doz sevanja razvil Medical Internal Radiation Dose (MIRD) Committee pri Združenju za nuklearno medicino (Society of Nuclear Medicine).
The undesirable effects due to Quadramet administration are linked with a decrease of red and white blood cells, and platelets. 
Neželeni učinki pri uporabi Quadrameta so povezani z zmanjšanjem števila rdečih in belih krvnih telesc ter trombocitov.
What Quadramet is and what it is used for 
Kaj je zdravilo Quadramet in za kaj ga uporabljamo
This medicinal product is not intended to be injected on a regular or continuous basis. 
QUADRAMET ni namenjen za redno ali trajno uporabo.
At 12 hours, 35.3 ± 13.6 % of the administered activity had been excreted into the urine. 
Po 12 urah se je 35,3 ± 13,6 % aplicirane radioaktivnosti izločilo v urinu.
Children and adolescents Quadramet is not recommended for use in children below 18 years of age. 
Otroci in mladostniki Uporaba zdravila Quadramet pri otrocih pod 18 let ni priporočljiva.
If your renal function is decreased, the amount of product will be adapted. 
Če je zmogljivost vaših ledvic zmanjšana, bodo temu primerno prilagodili količino zdravila.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT ml
Radioactive Sm-EDTMP has not been tested for mutagenicity/carcinogenicity but due to the radiation dose resulting from therapeutic exposure it should be regarded as presenting a genotoxic/carcinogenic risk. 
Radioaktivnega Sm-EDTMP niso preskušali na mutagenost/karcinogenost, vendar pa je treba upoštevati, da prejeta doza sevanja zaradi terapevtske izpostavljenosti lahko predstavlja določeno genotoksično /karcinogeno tveganje.
The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/kg. 
Produkti radiolize Sm-EDTMP so pokazali toksičnost za ledvica pri podganah in psih, raven brez ugotovljenih neželenih učinkov je bila pri koncentraciji 2,5 mg/kg.
Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days). 
Samarij-153 oddaja srednjeenergijske beta delce in gama foton, ki omogoča scintigrafijo ter ima razpolovni čas 46,3 ure (1,93 dneva).
Each vial contains 2-4 GBq at the reference date. 
Vsaka viala vsebuje 2 - 4 GBq na referenčni datum.
A small number of patients have reported a transient increase in bone pain shortly after injection (flare reaction). 
Majhno število bolnikov je navajalo, da so imeli kmalu po injekciji prehodno močnejše bolečine v kosteh (burna reakcija).
In the absence of genotoxic properties, these effects can be assigned to the EDTMP chelatant properties leading to osseous metabolism disturbances. 
Glede na odsotnost genotoksičnih lastnosti lahko te učinke povežemo s kelatnimi lastnostmi EDTMP, ki privedejo do motenj v kostnem metabolizmu.