FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Slovenian: V nadaljevanju so neželeni učinki navedeni po pogostnosti v skladu z naslednjim dogovorom: zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov pogosti: pojavijo se lahko pri največ 1 od
English: Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Zdravila Karvea ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Slovenian: (≥500 mg/kg/dan) so pri podganah in makako opicah sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
English: There is no experience regarding the administration of Karvea in patients with a recent kidney transplantation.
Slovenian: Glede uporabe zdravila Karvea pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Karvea on the progression of renal disease and all-cause mortality were examined.
Slovenian: Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/dan in serumskim kreatininom 1,03,0 mg/dl, so raziskovali dolgotrajne učinke zdravila Karvea (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Slovenian: Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Karvea ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Slovenian: Neželeni učinki, katerih pogostnost ni znana, so: vrtoglavica, glavobol, motnje okušanja, zvonjenje v ušesih, mišični krči, bolečine v sklepih in mišicah, zmanjšano število trombocitov, nenormalno delovanje jeter, zvišane vrednosti kalija v krvi, okvara delovanja ledvic, vnetje malih krvnih žil, predvsem kože
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Karvea Vsebina pakiranja in dodatne informacije
English: The blood pressure lowering effect of Karvea is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Slovenian: Učinek zdravila Karvea na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 46 tednov po začetku zdravljenja.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Karvea, amlodipine and placebo.
Slovenian: Karvea na obolevnost in smrtnost v primerjavi z amlodipinom in placebom.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: 10 bolnikov občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: 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
Slovenian: dodatke kalija nadomestke soli, ki vsebujejo kalij zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki)
English: Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Laktoza: Bolniki z redko dedno intoleranco za galaktozo, popolno odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: 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).
Slovenian: 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).
English: Karvea should not be given to children under 18 years of age.
Slovenian: Otroci in mladostniki, mlajši od 18 let, zdravila Karvea ne smejo jemati.
English: Each tablet of Karvea 75 mg contains 75 mg irbesartan.
Slovenian: Ena tableta zdravila Karvea 75 mg vsebuje 75 mg irbesartana.
English: B.
Slovenian: II.
English: Karvea is unlikely to affect your ability to drive or use machines.
Slovenian: Verjetnost, da bi zdravilo Karvea vplivalo na sposobnost upravljanja vozil ali strojev, je majhna.
English: Karvea 300 mg tablets irbesartan
Slovenian: Karvea 300 mg tablete irbesartan
English: Each tablet of Karvea 300 mg contains 300 mg irbesartan.
Slovenian: Ena tableta zdravila Karvea 300 mg vsebuje 300 mg irbesartana.
English: Sanofi AB
Slovenian: Sanofi S.p.A.
English: Each tablet of Karvea 150 mg contains 150 mg irbesartan.
Slovenian: Ena tableta zdravila Karvea 150 mg vsebuje 150 mg irbesartana.
English: 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.
Slovenian: 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.
English: Karvea 75 mg film-coated tablets irbesartan
Slovenian: Karvea 75 mg filmsko obložene tablete irbesartan
English: Karvea with food and drink Karvea can be taken with or without food.
Slovenian: Jemanje zdravila Karvea skupaj s hrano in pijačo
English: How to store Karvea
Slovenian: Shranjevanje zdravila Karvea
English: 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.
Slovenian: Podatkov o uporabi zdravila Karvea med dojenjem ni na voljo, zato uporaba zdravila Karvea med dojenjem ni priporočljiva.
English: 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).
Slovenian: 11,7 mmHg (nizki odmerek), 9,3 mmHg (srednji odmerek) oz. 13,2 mmHg (visoki odmerek).
English: Vistor hf.
Slovenian: Po peroralnem ali i.v.
English: Metabolism and nutrition disorders
Slovenian: Motnje reprodukcije in dojk
English: 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.
Slovenian: 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.
English: 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.
Slovenian: za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
English: 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).
Slovenian: IRMA 2 je dvojno slepa, s placebom kontrolirana raziskava smrtnosti pri 590 bolnikih z diabetesom tipa 2, mikroalbuminurijo (30
English: Karvea 150 mg film-coated tablets irbesartan
Slovenian: Karvea 150 mg filmsko obložene tablete irbesartan
English: Karvea 300 mg film-coated tablets irbesartan
Slovenian: Karvea 300 mg filmsko obložene tablete irbesartan
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg film-coated tablets.
Slovenian: Karvea 75 mg filmsko obložene tablete.
English: Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Slovenian: Karvea 75 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
English: Karvea 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Slovenian: Karvea 150 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
English: Some undesirable effects have been reported since marketing of Karvea.
Slovenian: Po prihodu zdravila Karvea na tržišče so poročali še o nekaterih drugih neželenih učinkih.
English: Karvea 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Slovenian: Karvea 300 mg tablete so na voljo v pretisnih omotih s 14, 28, 56 ali 98 tabletami.
English: Karvea 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Slovenian: Karvea 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
English: Karvea 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Slovenian: Karvea 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
English: Karvea 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 filmcoated tablets.
Slovenian: Karvea 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 ali 98 filmsko obloženimi tabletami.
English: Package leaflet: Information for the user Karvea 75 mg tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 75 mg tablete irbesartan
English: 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.
Slovenian: Karvea 75 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
English: NAME OF THE MEDICINAL PRODUCT Karvea 150 mg film-coated tablets.
Slovenian: Karvea 150 mg filmsko obložene tablete.
English: What Karvea contains  The active substance is irbesartan.
Slovenian: Zdravilna učinkovina je irbesartan.
English: 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.
Slovenian: 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.
English: Package leaflet: Information for the user Karvea 75 mg film-coated tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 75 mg filmsko obložene tablete irbesartan
English: 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
Slovenian: EU/1/97/049/014 - 56 x 1 tableta EU/1/97/049/006 - 98 tablet
English: 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
Slovenian: EU/1/97/049/015 - 56 x 1 tableta EU/1/97/049/009 - 98 tablet
English: Package leaflet: Information for the user Karvea 150 mg tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 150 mg tablete irbesartan
English: orthostatic hypotension* Uncommon: flushing Respiratory, thoracic and mediastinal disorders Uncommon: cough
Slovenian: hepatitis, motnje v delovanju jeter Bolezni kože in podkožja: Neznana:
English: NAME OF THE MEDICINAL PRODUCT Karvea 300 mg film-coated tablets.
Slovenian: Karvea 300 mg filmsko obložene tablete.
English: 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
Slovenian: EU/1/97/049/013 - 56 x 1 tableta EU/1/97/049/003 - 98 tablet
English: Package leaflet: Information for the user Karvea 150 mg film-coated tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 150 mg filmsko obložene tablete irbesartan
English: 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.
Slovenian: Karvea 150 mg filmsko obložene tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
English: Package leaflet: Information for the user Karvea 300 mg tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 300 mg tablete irbesartan
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: Če opazite katerikoli neželeni učinek se posvetujte z zdravnikom ali s farmacevtomPosvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu
English: NAME OF THE MEDICINAL PRODUCT Karvea 75 mg tablets.
Slovenian: Karvea 75 mg tablete
English: 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.
Slovenian: Karvea 75 mg tablete so bele do kremaste barve, izbočene na obeh straneh in ovalne oblike.
English: Package leaflet: Information for the user Karvea 300 mg film-coated tablets irbesartan
Slovenian: Navodilo za uporabo Karvea 300 mg filmsko obložene tablete irbesartan
English: 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
Slovenian: EU/1/97/049/024 - 56 x 1 tableta EU/1/97/049/032 - 84 tablet
English: Energy (keV)*
Slovenian: Energija (keV)*
English: This should be taken into consideration when using the following information:
Slovenian: To je treba upoštevati tudi pri uporabi naslednjih podatkov:
English: MARKETING AUTHORISATION NUMBER EU/1/97/057/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/97/057/001
English: Such reactions are usually responsive to analgesics.
Slovenian: Take reakcije se običajno odzivajo na analgetike.
English: He will decide at which time you will be authorised to leave the nuclear medicine department.
Slovenian: Zdravnik bo odločil, kdaj vam bo dovoljeno oditi z oddelka za nuklearno medicino.
English: Date of latest renewal: 12 December 2007
Slovenian: Datum zadnjega podaljšanja: 12. december 2007
English: This effect is moderate and brief and will disappear after some hours.
Slovenian: Ta učinek je zmeren in kratkotrajen in po nekaj urah izgine.
English: It should be clear without particles.
Slovenian: Biti mora bistra, brez delcev.
English: Relief of pain may persist for 4 weeks up to 4 months.
Slovenian: Olajšanje bolečine traja 4 tedne do 4 mesece.
English: The leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: • in pregnant women (See section 4.6).
Slovenian: • pri nosečnicah (glejte poglavje 4.6)
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Slovenian: V vseh primerih moramo zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 05 February 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 5. februar 1998
English: (See section 12, for detailed instructions of product preparation)
Slovenian: (Glejte poglavje 12, kjer so natančna navodila za pripravo zdravila)
English: You should not be alarmed at this; in such case, your pain medicine will be slightly increased.
Slovenian: To naj vas ne vznemirja; v takem primeru vam bodo nekoliko povečali odmerek vašega zdravila proti bolečinam.
English: Cases of bleeding have been reported, some of which have been serious.
Slovenian: Poročali so o primerih krvavitev, tudi resnejših.
English: After thawing, do not freeze again.
Slovenian: Po odmrznjenju ne smete ponovno zamrzovati.
English: (12 h CET)
Slovenian: (12 h po srednjeevropskem času)
English: Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5 %).
Slovenian: Izločanje z urinom je potekalo pretežno v prvih 4 urah (30,3 ± 13,5 %).
English: BATCH NUMBER Batch :
Slovenian: ŠTEVILKA SERIJE Batch:
English: For instructions on preparation of the medicinal product before administration, see section 12.
Slovenian: Za navodila glede priprave zdravila pred dajanjem glejte poglavje 12.
English: Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.
Slovenian: Bolnike, ki zaznajo zmanjšanje bolečine, lahko vzpodbudimo k zmanjšanju uporabe opioidnih analgetikov.
English: Women of childbearing potential have to use effective contraception during the treatment and the whole period of follow-up.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in celotnem kontrolnem obdobju.
English: At 4 and 24 hours, plasma radioactivity had decreased from 1.3 ± 0.7 % to 0.05 ± 0.03 %.
Slovenian: Po 4 in 24 urah je radioaktivnost v plazmi padla od 1,3 ± 0,7 % na 0,05 ± 0,03 %.
English: GBq/vial,
Slovenian: GBq/viala,
English: In patients, Quadramet is rapidly cleared from the blood.
Slovenian: Pri bolnikih se Quadramet hitro izloči iz krvi.
English: A positive correlation was found between skeletal uptake and the number of metastatic sites.
Slovenian: Ugotovljena je bila pozitivna korelacija med kopičenjem v skeletu in številom metastatskih mest.
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
Slovenian: Prevzem, shranjevanje, uporaba, premeščanje in odlaganje radiofarmakov mora potekati v skladu s predpisi in ustreznimi dovoljenji odgovornih lokalnih uradnih organizacij.
English: These effects were deemed to be related to the progression of the disease.
Slovenian: Ti učinki so bili po mnenju poročevalcev povezani z napredovanjem bolezni.
English: In the absence of compatibility studies, this medicinal product must not be mixed with the other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: Repeat administration of Quadramet should be based on an individual patient's response to prior treatment and on clinical symptoms.
Slovenian: Ponovna aplikacija Quadrameta mora temeljiti na odzivu posameznega bolnika na predhodno zdravljenje ter na kliničnih simptomih.
English: 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.
Slovenian: 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..
English: The administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease.
Slovenian: Dajanje pa se lahko ponovi 8 tednov po prejemu injekcije, glede na potek vaše bolezni.
English: Quadramet is contra-indicated (see 4.3) in pregnancy.
Slovenian: Zdravilo Quadramet je kontraindicirano (glejte poglavje 4.3) med nosečnostjo.
English: In contrast, skeletal uptake was inversely proportional to plasma radioactivity at 30 minutes.
Slovenian: Nasprotno pa je bilo kopičenje v skeletu obratno sorazmerno s plazemsko radioaktivnostjo po 30 minutah.
English: You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection).
Slovenian: Oddelek za nuklearno medicino vam bo dovoljeno zapustiti po opravljeni kontroli sevanja (običajno v 6 urah po prejemu injekcije Quadrameta).
English: TABLE 2 : RADIATION ABSORBED DOSES
Slovenian: TABELA 2: ABSORBIRANE DOZE SEVANJA Organ
English: He/she will be released when exposure rates comply with the limits prescribed by the regulations in force.
Slovenian: Bolnik/bolnica bo odpuščen, ko bo stopnja izpostavljenosti v mejah, ki jih predpisuje veljavna zakonodaja.
English: In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours.
Slovenian: V primeru urinske inkontinence ali urinske zapore vam bodo za 6 ur vstavili urinski kateter.
English: Effective dose (mSv/MBq)
Slovenian: Efektivna doza (mSv/MBq)
English: Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Slovenian: Bolnišnično osebje bo poskrbelo, da bo zdravilo pravilno shranjeno in da ga ne boste dobili po izteku navedenega roka uporabnosti.
English: Less urinary excretion occurred in patients who had extensive bony metastases, regardless of the amount of radiopharmaceutical administered.
Slovenian: Izločanje v urinu je bilo manjše pri bolnikih, ki so imeli obsežne kostne metastaze, ne glede na količino apliciranega radiofarmaka.
English: No studies have been performed to assess the effect of Quadramet on reproduction.
Slovenian: Do sedaj niso opravili študij, v katerih bi ocenjevali vpliv Quadrameta na reprodukcijo.
English: In a carcinogenic potential study of EDTMP, osteosarcomas occurred in rats at high doses.
Slovenian: V študiji karcinogenega potenciala EDTMP so se pri podganah ob visokih odmerkih pojavili osteosarkomi.
English: Quadramet must not be administered to pregnant women.
Slovenian: Quadramet se ne sme dajati nosečnicam.
English: Excipient with known effect: sodium 8.1 mg/mL.
Slovenian: Pomožne snovi z znanim učinkom: natrij 8,1 mg/ml.
English: Manufacturer: CIS bio international.
Slovenian: Proizvajalec: CIS bio international
English: The primary radiation emissions of samarium-153 are shown in Table 1.
Slovenian: Primarne emisije sevanja samarija-153 so navedene v Tabeli 1.