natgillin/translations-raw huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has QUADRAMET been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged hitre rasti kosti, kot so osteoblastne metastaze.
In one of the studies, which involved patients with bone metastases from prostate cancer, the patients ’ use of opioid analgesics (such as morphine) was also reduced following treatment with QUADRAMET.
V eni izmed študij, ki je vključevala bolnike s kostnimi metastazami zaradi rakavega obolenja prostate, je po zdravljenju z zdravilom QUADRAMET prišlo tudi do zmanjšanja uporabe opiatnih analgetikov (kot je na primer morfin).
The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET’ s benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila QUADRAMET pri lajšanju bolečin v kosteh pri bolnikih z množičnimi bolečimi osteoblastnimi kostnimi metastazami večje od z njim povezanih tveganj.
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Stran 2/ 2 ©EMEA 2008
Route of administration Packaging
Način uporabe
QUADRAMET, solution for injection.
QUADRAMET raztopina za injiciranje
Each ml of solution contains 1.3 GBq Samarium [153Sm] lexidronam pentasodium at the reference date (corresponding to 20 to 46 µg/ ml of samarium per vial)
En ml raztopine vsebuje 1, 3 GBq [153Sm] samarij- leksidronam, pentanatrijeve soli, na referenčni datum (ustreza 20 do 46 µg/ ml samarija na vialo)
Samarium specific activity is approximately 28 – 65 MBq/ µg of samarium.
Specifična aktivnost samarija je približno 28 – 65 MBq/ µg samarija.
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).
The primary radiation emissions of samarium-153 are shown in Table 1.
Primarne emisije sevanja samarija- 153 so navedene v Tabeli 1.
TABLE 1:
TABELA 1:
SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA Radiation Beta Beta Beta Gamma
GLAVNE EMISIJE SEVANJA SAMARIJA- 153 Sevanje Beta Beta Beta Gama
Energy (keV)* 640 710 810 103
Energija (keV) * 640 710 810 103
Abundance 30% 50% 20% 29%
Razvejitveno razmerje 30% 50% 20% 29%
* Maximum energies are listed for the beta emissions, the average beta particle energy is 233 keV.
* Največje energije so navedene za sevanja beta, povprečna energija beta delcev je 233 keV.
Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
Bistra, brezbarvna do svetlo jantarna raztopino, ki ima pH med 7, 0 in 8, 5.
QUADRAMET is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan.
QUADRAMET je indiciran za lajšanje bolečin v kosteh pri bolnikih z množičnimi bolečimi osteoblastnimi kostnimi metastazami, ki na scintigrafiji kosti kopičijo s tehnecijem [99mTc] označene bifosfonate.
The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Pred uvedbo zdravljenja moramo potrditi prisotnost osteoblastnih metastaz, ki kopičijo s tehnecijem [99mTc] označene bifosfonate.
QUADRAMET should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.
QUADRAMET smejo dajati le zdravniki, ki imajo izkušnje z uporabo radiofarmakov, ko je zdravnik - specialist podal celotno onkološko oceno bolnika.
The recommended dose of QUADRAMET is 37 MBq per kg body weight and is to be administered by slow intravenous route through an established intravenous line over a period of one minute.
Priporočen odmerek QUADRAMETa znaša 37 MBq na kg telesne mase, dajemo pa ga počasi intravensko v trajanju 1 minute po vzpostavljenem intravenskem kanalu.
QUADRAMET should not be diluted before use.
QUADRAMETa pred uporabo ne smete redčiti.
2 Patients who respond to QUADRAMET generally experience the onset of pain relief within 1 week after treatment.
2 Bolniki, ki se odzivajo na QUADRAMET, običajno začutijo olajšanje bolečine v prvem tednu po začetku terapije.
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.
QUADRAMET is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila QUADRAMET pri otrocih pod 18 let ni priporočljiva.
QUADRAMET is contra-indicated: • Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP) or similar phosphonates) or to any of the excipients. • in pregnant women (See section 4.6). • in patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks.
• preobčutljivost za zdravilno učinkovino (etilendiamintetrametilenfosfonat (EDTMP) ali podobne fosfonate) ali katerokoli pomožno snov • pri nosečnicah (glejte poglavje 4. 6) • pri bolnikih, ki so se v preteklih 6 tednih zdravili s kemoterapijo ali zunanjim obsevanjem polovice telesa.
QUADRAMET is used only as a palliative agent and should not be used concurrently with myelotoxic chemotherapy as this may enhance myelotoxicity.
QUADRAMET uporabljamo le kot paliativno sredstvo in ga ne smemo dajati sočasno z mielotoksično kemoterapijo, ker lahko poveča mielotoksični učinek.
It should not be used concurrently with other biphosphonates if an interference is shown on the technetium [99mTc]-labelled biphosphonate bone scans.
Ne smemo ga uporabljati sočasno z drugimi bifosfonati, če je na scintigrafiji kosti s [99mTc] tehnecijem označenega bifosfonata vidna interferenca.
Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefit of the treatment outweighs its risks.
Pri bolnikih, ki imajo zaradi predhodne terapije ali bolezni zmanjšano rezervo kostnega mozga, uporabe QUADRAMETa ne priporočamo, razen če pričakovana korist zdravljenja odtehta tveganje.
Because of potential bone marrow suppression after administration, blood counts should be monitored weekly for at least 8 weeks, beginning 2 weeks after administration of QUADRAMET, or until recovery of adequate bone marrow function.
Zaradi verjetnosti pojava supresije kostnega mozga po aplikaciji QUADRAMETa moramo 2 tedna po aplikaciji tedensko spremljati krvno sliko vsaj 8 tednov, ali do ponovne vzpostavitve ustrezne funkcije kostnega mozga.
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.
3 Radiopharmaceuticals may be received, used and administered only by authorised persons in designated clinical settings.
Prejemanje, uporaba in dajanje radiofarmakov sme potekati le v določenih kliničnih ustanovah, poseg pa smejo izvajati le za to pooblaščene osebe.
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
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
3 odlaganje radiofarmakov mora potekati v skladu s predpisi in ustreznimi dovoljenji odgovornih lokalnih uradnih organizacij.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji in farmacevtske kakovosti.
QUADRAMET may be given subsequent to either of these treatments after allowing for adequate marrow recovery.
Zdravilo QUADRAMET lahko dajemo po zaključku teh terapij, oziroma, ko se kostni mozeg ustrezno opomore.
QUADRAMET is contra-indicated(see 4.3) in pregnancy.
Zdravilo QUADRAMET je kontraindicirano (glejte poglavje 4. 3) med nosečnostjo.
There are no available clinical data relating to the excretion of QUADRAMET in human milk.
Na razpolago ni kliničnih podatkov o izločanju QUADRAMETa v mleku doječih mater.
If therefore QUADRAMET administration is deemed necessary, formula feeding should be substituted for breast-feeding and the expressed feeds discarded.
Če je torej v tem obdobju zdravljenje s QUADRAMETom nujno, moramo namesto dojenja uvesti hranjenje z umetnim mlekom, izločeno materino mleko pa zavreči.
Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving QUADRAMET.
Pri bolnikih, ki so prejemali QUADRAMET, so opazili zmanjšanje števila levkocitov in trombocitov ter pojav anemije.
In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40% to 50% of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks post treatment.
V kliničnih preskušanjih je ob največjem padcu število levkocitov in trombocitov znašalo približno 40% - 50% njihove izhodiščne vrednosti; te najnižje vrednosti so bile zabeležene 3- 5 tednov po aplikaciji odmerka in so se zopet vrnile v izhodiščno stanje 8 tednov po terapiji.
The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with probable bone marrow involvement.
Postmarketinška poročila o trombocitopeniji vključujejo posamezne primere intrakranialne krvavitve in primere s smrtnim izidom.
Postmarketing reports of thrombocytopenia have included isolated reports of intracranial haemorrhage, and cases in which the outcome was fatal.
Redki bolniki, pri katerih se je pojavila toksičnost 3- 4 stopnje za krvotvorne organe, so bili predhodno zdravljeni bodisi z obsevanjem ali kemoterapijo ali pa so imeli hitro napredujočo bolezen z verjetno razširitvijo v kostni mozeg.
Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after QUADRAMET administration.
Po dajanju zdravila QUADRAMET poročajo tudi o preobčutljivostnih reakcijah, vključno z redkimi primeri anafilaktične reakcije.
A few patients experienced cord/ root compressions, disseminated intravascular coagulation and cerebrovascular accidents.
Nekaj bolnikov je imelo kompresijo hrbtenjače ali korenin, diseminirano intravaskularno koagulacijo in cerebrovaskularni insult.
When there are spinal metastases at the cervico-dorsal level, an increased risk of spinal cord compression cannot be excluded.
Kadar gre za metastaze v hrbtenici na cerviko- dorzalni ravni, ne moremo izključiti povečanega tveganja za kompresijo hrbtenjače.
4 The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
4 Prejeta doza sevanja zaradi terapevtske izpostavljenosti lahko povzroči večjo pojavnost rakavih obolenj in mutacij.
ATC Code:
Farmakoterapevtska skupina: razni radioterapevtiki za lajšanje bolečin, Oznaka ATC:
QUADRAMET has an affinity for skeletal tissue and concentrates in areas of bone turnover in intimate association with hydroxyapatite; studies in rats have demonstrated that QUADRAMET is cleared rapidly from the blood and localises to growing areas of bone matrix, specifically the layer of osteoid undergoing mineralisation.
Študije na podganah so pokazale, da se QUADRAMET hitro izloči iz krvi in se lokalizira v rastnih delih kostnega matriksa, zlasti v plasti osteoidov, kjer prihaja do mineralizacije.
In clinical studies employing planar imaging techniques, QUADRAMET accumulates with a lesion- to-normal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6.
V kliničnih študijah, kjer uporabljajo planarne tehnike slikanja, se QUADRAMET v lezijah kopiči v razmerju približno 5: 1 glede na normalno kostno tkivo in v razmerju 6: 1 glede na mehko tkivo.
Thus, areas of metastatic involvement can accumulate significantly greater amounts of QUADRAMET than surrounding normal bone.
Tako lahko področja metastatske rašče akumulirajo značilno večje količine QUADRAMETa kot okolno normalno kostno tkivo.
In patients, QUADRAMET is rapidly cleared from the blood.
Pri bolnikih se QUADRAMET hitro izloči iz krvi.
Thirty minutes after injection of the agent to 22 patients, only 9.6 ± 2.8% of the administered activity remained in plasma.
30 minut po tem, ko so 22 bolnikom injicirali QUADRAMET, je bilo v plazmi prisotno le še 9, 6 ± 2, 8% aplicirane radioaktivnosti.
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%.
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%).
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.
Analysis of urine samples found the radioactivity to be present as the intact complex.
Analiza vzorcev urina je pokazala, da je bila radioaktivnost prisotna v obliki nespremenjenega kompleksa.
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.
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.
Repeated dose administration of samarium [153Sm]-EDTMP to dogs indicated a slightly longer time for depressed bone marrow and peripheral haematological parameters to recover when compared to recovery following only single dose administration.
Pokazalo se je, da - v primerjavi z enkratno aplikacijo - po ponavljajoči aplikaciji odmerka samarija [153Sm] - EDTMP pri psih traja nekoliko dlje, da se prizadeti kostni mozeg in periferni hematološki parametri spet normalizirajo.
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.
5 Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of in vivo and in vitro tests.
5 V seriji in vivo in in vitro testov neradioaktivni Sm- EDTMP ni imel mutagenega potenciala.
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.
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.
Total EDTMP (as EDTMP. H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
Skupni EDTMP (v obliki EDTMP. H2O) Kalcij- EDTMP natrijeva sol (v obliki Ca) Skupni natrij (kot Na) Voda za injekcije
QUADRAMET is delivered frozen in dry ice.
QUADRAMET se dostavlja zmrznjen v suhem ledu.
Store in a freezer at -10°C to -20°C in the original package.
Shranjujte v zamrzovalniku pri temperaturi - 10 °C do - 20 °C v originalni ovojnini.
15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/ natural rubber stopper and aluminium flip-off overseal.
Brezbarvna 15- ml viala iz vlečenega stekla tipa I po Evropski farmakopeji, zaprta s teflonsko prevlečenim klorobutilnim zamaškom iz naravne gume in aluminijasto zaščitno zaporko.
Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
Vsaka viala vsebuje 1, 5 ml (2 GBq ob kalibraciji) do 3, 1 ml (4 GBq ob kalibraciji) raztopine za injiciranje.
The administration of radiopharmaceuticals creates risks to other persons from external radiation or contamination from spills of urine, vomiting etc.
Aplikacija radiofarmakov predstavlja tveganje izpostavljenosti sevanju drugih oseb ali kontaminaciji zaradi razlitja urina, bruhanja ipd.
CIS bio international Boîte Postale 32 F-91192 GIF-SUR-YVETTE Cedex FRANCE
CIS bio international Boîte Postale 32 F- 91192 GIF- SUR- YVETTE Cedex FRANCIJA
Date of the first authorisation:
Datum pridobitve:
05.02.1998 Date of the last renewal:
05. 02. 1998 Datum zadnjega podaljšanja:
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.
Because QUADRAMET is excreted in the urine, radiation exposure was based on a urinary voiding interval of 4.8 hours.
Ker se zdravilo QUADRAMET izloča v urinu, so pri izpostavljenosti sevanju upoštevali 4, 8- urni interval pri odvajanju urina.
Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, in accordance with autoradiograms of bone samples taken from patients who received QUADRAMET.
Pri oceni prejetih doz sevanja na kosti in kostni mozeg se predvideva, da se, skladno z avtoradiogrami kostnih vzorcev odvzetih bolnikom, ki so prejemali zdravilo QUADRAMET, radioaktivnost nalaga na površini kosti..
7 Radiation dose to specific organs, which may not be the target organ of therapy, may be influenced significantly by pathophysiological changes induced by the disease process.
7 Na doze sevanja, ki jih prejmejo posamezni organi, ki niso ciljni organi zdravljenja, lahko značilno vplivajo patofiziološke spremembe, ki jih sproži bolezenski proces.
TABLE 2:
TABELA 2:
RADIATION ABSORBED DOSES Organ Adrenals Brain Chest Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys Liver Lungs Muscle Ovaries Pancreas Red marrow Bone surfaces Skin Spleen Stomach Testes Thymus Thyroid Urinary bladder wall Uterus Effective dose (mSv/ MBq)
jajčniki jetra koža ledvice maternica mišice možgani nadledvične žleze pljuča površina kosti prsni koš rdeči kostni mozeg ščitnica stena ascendentnega kolona stena descendentnega kolona
Absorbed dose per injected activity (mGy/ MBq) 0.009 0.011 0.003 0.004 0.005 0.010 0.006 0.005 0.018 0.005 0.008 0.007 0.008 0.005 1.54 6.76 0.004 0.004 0.004 0.005 0.004 0.007 0.973 0.011 0.307
stena sečnega mehurja stena miokarda tanko črevo testisi timus trebušna slinavka vranica želodec žolčnik Efektivna doza (mSv/ MBq)
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.
Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.
Pred aplikacijo zdravila QUADRAMET morate verificirati odmerek in identificirati bolnika.
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.
CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette cedex France
CIS bio international Boîte Postale 32 F - 91192 GIF- SUR- YVETTE Cedex Francija
{METALLIC BOX / LEADPOT}
{KOVINSKA ŠKATLA / SVINČENI VSEBNIK}
QUADRAMET, solution for injection
QUADRAMET raztopina za injiciranje.
Samarium [153Sm] lexidronam pentasodium (Corresponding to 20 to 46 µg/ ml of samarium)
(odgovarja 20 – 46 µg/ ml samarija)
1.3 GBq/ ml at reference date.
1, 3 GBq/ ml na datum kalibracije.
Total EDTMP (as EDTMP. H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for injections
skupni EDTMP (v obliki EDTMP. H2O) kalcij- EDTMP natrijeva sol (v obliki Ca) skupni natrij (kot Na) voda za injekcije
GBq/ vial,
GBq/ viala,
Read package leaflet before use
Pred uporabo preberite priloženo navodilo.
Keep out of reach and sight of children
Zdravilo shranjujte nedosegljivo otrokom!
OTHER SPECIAL WARNING
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
DD/ MM/ YYYY (12 h CET)
(12 h po srednjeevropskem času)
Store in a freezer at -10°C to -20°C in the original package
Shranjujte v zamrzovalniku pri temperaturi - 10 °C do - 20 °C v originalni ovojnini.
Use within 6 hours of thawing
Uporabite v 6 urah po odmrznjenju.
Dispose of as radioactive waste in accordance with local law
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
CIS bio international, Boîte Postale 32, 91192 GIF-SUR-YVETTE Cedex, FRANCE
CIS bio international Boîte Postale 32 F- 91192 GIF- SUR- YVETTE Cedex FRANCIJA
< Justification for not including Braille accepted >
< Sprejeta je utemeljitev, da Braillova pisava ni potrebna >
15 MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
15 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
QUADRAMET, solution for injection Samarium [153Sm] lexidronam pentasodium For intravenous use
QUADRAMET raztopina za injiciranje [153Sm] samarij- leksidronam, pentanatrijeva sol Za intravensko uporabo
CIS bio international.
CIS bio international
QUADRAMET, solution for injection Samarium [153Sm] lexidronam pentasodium.
QUADRAMET raztopina za injiciranje [153Sm] samarij- leksidronam, pentanatrijeva sol
What QUADRAMET is and what it is used for 2.
Kaj je zdravilo QUADRAMET in za kaj ga uporabljamo 2.
Before you take QUADRAMET 3.
Kaj morate vedeti, preden boste vzeli zdravilo QUADRAMET 3.
How to take QUADRAMET 4.
Kako jemati zdravilo QUADRAMET 4.
How to store QUADRAMET 6.
Shranjevanje zdravila QUADRAMET 6.
WHAT QUADRAMET IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO QUADRAMET IN ZA KAJ GA UPORABLJAMO
QUADRAMET is a medicinal product for therapeutic use only.
QUADRAMET je zdravilo, namenjeno izključno za terapevtsko uporabo.
This radiopharmaceutical is used for the treatment of bone pain due to your disease.
QUADRAMET se uporablja za zdravljenje bolečin v kosteh, ki jih povzroča vaša bolezen.
QUADRAMET has a high affinity for skeletal tissue.
QUADRAMET ima veliko afiniteto do kostnega tkiva.
Because QUADRAMET contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
Ker QUADRAMET vsebuje majhne količine radioaktivnega elementa samarija- 153, je sevanje lokalno na kostne lezije, kjer ima paliativni učinek – lajša kostne bolečine.
BEFORE YOU TAKE QUADRAMET
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO QUADRAMET
Do not take QUADRAMET:
Ne jemljite zdravila QUADRAMET: