natgillin/translations-raw huggingface dataset:
At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
V 48 urah po injiciranju se približno 60% radioaktivnosti izloči z urinom; izračuni kažejo, da se z blatom izloči približno 14%.
5.3 Preclinical safety data
5 5. 3 Predklinični podatki o varnosti
Acute toxicity studies employing ioflupane at dosage levels of 0.06 mg/ kg, in excess of 6,500 times the maximum human (70 kg) single dose on a bodyweight basis, failed to reveal any mortality or signs of systemic toxicity in rats or rabbits.
Študije akutne toksičnosti pri odmerkih 0, 06 mg/ kg, kar presega 6. 500- kratni najvišji dovoljeni enkratni odmerek na enoto telesne mase pri človeku (70 kg), pri podganah in zajcih niso pokazale smrtnosti ali znakov sistemske toksičnosti.
In 14 day repeat dose studies no evidence of toxicity was observed in rats or rabbits following daily doses of 0.6 mg/ kg ioflupane, more than 65,000 times the maximum
Študije 14- dnevnih ponavljajočih se odmerkov niso pokazale nikakršne toksičnosti pri podganah in zajcih po dnevnih odmerkih 0, 6 mg/ kg ioflupana, kar je več kot 65. 000- kratni najvišji dovoljeni enkratni odmerek na enoto telesne mase pri človeku (70 kg).
Behavioural effects due to pharmacological activity were observed in these studies.
V teh študijah so ugotovili vedenjske spremembe, ki so bile posledica farmakološke aktivnosti.
Studies on reproductive toxicity have not been conducted.
Študij vpliva na razmnoževanje niso opravili.
Ioflupane showed no evidence of mutagenic potential in in vitro or in vivo mutagenicity studies.
Ioflupan ni pokazal mutagenega potenciala v študijah mutagenosti in vitro ali in vivo.
Studies to assess the carcinogenic potential of ioflupane have not been performed.
Študij kancerogenega potenciala ioflupana niso opravili.
Acetic acid Sodium acetate Ethanol Water for injections
Ocetna kislina Natrijev acetat Etanol Voda za injiciranje
2.5 ml presentation:
Pakiranje po 2, 5 ml:
7 hours from the activity reference time stated on the label (35 hours from the end of manufacture).
7 ur po referenčnem času aktivnosti, navedenem na oznaki (35 ur po končani proizvodnji).
5.0 ml presentation:
Pakiranje po 5, 0 ml:
20 hours from the activity reference time stated on the label (48 hours from the end of manufacture).
20 ur po referenčnem času aktivnosti, navedenem na oznaki (48 ur po končani proizvodnji).
The product is supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Zdravilo je pakirano v enojne, brezbarvne 10- mililitrske viale, zaprte z gumijastim zapiralom in kovinskim tesnilom.
The 2.5 ml presentation contains 185 MBq at reference in 2.5 ml of solution.
Pakiranje po 2, 5 ml vsebuje 185 MBq v 2, 5 ml raztopine v referenčnem času.
The 5.0 ml presentation contains 370 MBq at reference in 5.0 ml of solution.
Pakiranje po 5, 0 ml vsebuje 370 MBq v 5, 0 ml raztopine v referenčnem času.
6 7.
6. 6 Posebni varnostni ukrepi za odstranjevanje
MARKETING AUTHORISATION HOLDER
6 IMETNIK DOVOLJENJA ZA PROMET 7.
GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom
GE Healthcare Limited Little Chalfont Bucks HP7 9NA Velika Britanija
27 July 2000 Date of last renewal:
27. julij 2000 Datum zadnjega podaljšanja:
11 DOSIMETRY
DOZIMETRIJA
Iodine-123 has a physical half-life of 13.2 hours.
Jod- 123 ima fizični razpolovni čas 13, 2 ure.
The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter).
Pri izračunu vrednosti sta bila predpostavljena praznjenje mehurja v 4, 8- urnih presledkih in ustrezno blokiranje ščitnice (jod- 123 je znan Augerjev oddajnik elektronov).
7 Absorbed radiation dose Target Organ μ Gy/ MBq Adrenals Brain Breasts Gallbladder wall Lower large intestine wall Small intestine Stomach Upper large intestine wall Heart wall Kidneys Liver Lungs Muscle Ovaries Pancreas Bone marrow Bone surfaces Skin Spleen Testes Thymus Thyroid Urinary bladder wall Uterus Total body
7 Tarčni organ
Effective Dose
Absorbiran odmerek sevanja μGy/ MBq
23.5
Nadledvični žlezi Možgani Dojki Stena žolčnika Stena spodnjega debelega črevesa Tanko črevo Želodec Stena zgornjega debelega črevesa Srčna stena Ledvici Jetra Pljuča Mišice Jajčniki Trebušna slinavka Kostni mozeg Površina kosti Koža Vranica Moda Priželjc Ščitnica Stena sečnega mehurja Maternica Celotno telo Učinkovit odmerek
μ Sv/ MBq
13. 1 18. 1 8. 0 25. 7 42. 4 20. 6 11. 4 38. 1 13. 1 11. 1 28. 3 42. 5 9. 6 17. 0 13. 2 9. 8 17. 4 6. 3 10. 6 8. 8 10. 3 9. 2 53. 5 16. 3 11. 5 23. 5 μSv/ MBq
The effective dose (E) resulting from administration of a 185 MBq dose of DaTSCAN injection is 4.35 mSv (per 70 kg individual).
Učinkovit odmerek (E), ki nastane z injiciranjem odmerka 185 MBq DaTSCANA, je 4, 35 mSv (pri osebi, ki tehta 70 kg).
See also section 6.6.
Glejte tudi poglavje 6. 6.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
9 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Den Dolech 2 NL-5612 AZ, Eindhoven The Netherlands
Den Dolech 2 NL- 5612 Az, Eindhoven Nizozemska
Medicinal product subject to restricted medical prescription (See Annex I:
Izdaja zdravila je le na recept (Glej Dodatek I:
Summary of Product Characteristics, Section 4.2).
Povzetek glavnih značilnosti zdravila, 4. 2)
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
12 PODATKI NA ZUNANJI OVOJNINI
5.0 ml presentation
pakiranje po 5, 0 ml
Ioflupane (123I) 74 MBq/ ml
DaTSCAN 74 MBq/ ml raztopina za injiciranje Ioflupan (123I) 74 MBq/ ml
Ioflupane (123I) 74 MBq/ ml at activity reference time.
Ioflupan (123I) 74 MB q/ ml v referenčnem času aktivnosti.
5% ethanol, acetic acid, sodium acetate, water for injections.
5% etanol, ocetna kislina, natrijev acetat, voda za injekcije.
5.0 ml Solution for injection
5, 0 ml Raztopina za injiciranje
Keep out of reach and sight of children.
Zdravilo shranjujte nedosegljivo otrokom!
20 h post-ref.
20 h po ref.
370 MBq/ 5.0 ml at 2300 CET on DD/ MM/ YYYY
370 MBq/ 5, 0 ml ob 2300 CET dne DD/ MM/ LLLL
Do not store above 25°C.
Zdravilo shranjujte pri temperaturi do 25°C.
GE Healthcare Limited Little Chalfont HP7 9NA UK
GE Healthcare Limited Little Chalfont HP7 9NA Velika Britanija
Lot :< XXXXXXX >
Serija: < XXXXXXX >
DaTSCAN 74 MBq/ ml solution for injection.
DaTSCAN 74 MBq/ ml raztopina za injiciranje.
370 MBq/ 5.0 ml Ioflupane (123I) at 2300 CET on DD/ MM/ YYYY.
370 MBq/ 5, 0 ml Ioflupan (123I) ob 2300 CET dne DD/ MM/ LLLL
2.5 ml presentation
pakiranje po 2, 5 ml
DaTSCAN 74 MBq/ ml solution for injection Ioflupane (123I) 74 MBq/ ml
DaTSCAN 74 MBq/ ml raztopina za injiciranje Ioflupan (123I) 74 MBq/ ml
2.5 ml Solution for injection
2, 5 ml Raztopina za injiciranje
7 h post-ref.
7 h po ref.
185 MBq/ 2.5 ml at 1200 CET on DD/ MM/ YYYY
185 MBq/ 2, 5 ml ob 1200 CET dne DD/ MM/ LLLL
Do not store above 25°C.
Zdravilo shranjujte pri temperaturi do 25° C.
185 MBq/ 2.5 ml Ioflupane (123I)at 1200 CET on DD/ MM/ YYYY
185 MBq/ 2, 5 ml Ioflupan (123I) ob 1200 CET dne DD/ MM/ LLLL
INFORMATION FOR THE USER
NAPOTKI ZA UPORABNIKA
DaTSCAN 74 MBq/ ml solution for injection Ioflupane (123I)
DaTSCAN 74 MBq/ ml raztopina za injiciranje Ioflupan (123I)
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Pred uporabo natančno preberite navodilo.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What DaTSCAN is and what it is used for 2.
Kaj je DaTSCAN in za kaj ga uporabljamo 2.
Before you use DaTSCAN 3.
Kaj morate vedeti, preden boste uporabili DaTSCAN 3.
How DaTSCAN is used 4.
Kako uporabljamo DaTSCAN 4.
How DaTSCAN is stored 6.
Kako shranjujemo DaTSCAN 6.
WHAT DaTSCAN IS AND WHAT IT IS USED FOR
KAJ JE DaTSCAN IN ZA KAJ GA UPORABLJAMO
DaTSCAN contains Ioflupane (123I) which is used to help identify (diagnose) conditions in the brain.
DaTSCAN vsebuje ioflupan (123I), ki se uporablja za odkrivanje (diagnosticiranje) stanj v možganih.
It belongs to a group of medicines called “ radiopharmaceuticals”, which contain a small amount of radioactivity. • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time. • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras. • A picture, known as a scan, can be taken.
• Radiofarmak se po injiciranju za kratek čas nakopiči v določenem organu ali delu telesa. • Ta proizvod je nizko radioaktiven, zato ga lahko zaznamo s posebnimi kamerami zunaj telesa. • Posnamemo lahko sliko.
When DaTSCAN is injected into you, it is carried around the body in the blood.
Ko vam vbrizgajo DaTSCAN, se ta s krvjo prenaša po telesu.
Changes in this area of the brain occur in: • Parkinsonism (including Parkinson’ s disease) and • dementia with Lewy bodies.
Do sprememb v tem delu možganov pride pri: • parkinsonizmu (vključno s Parkisonovo boleznijo) in • demenci, povezani z Lewyjevimi telesci.
BEFORE YOU USE DaTSCAN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI DaTSCAN?
Do not use DaTSCAN if:
Ne uporabljajte DaTSCAN- a, če:
• you are pregnant • you are allergic (hypersensitive) to iodide or any of the other ingredients of DaTSCAN (see Section 6:
• ste noseči • ste alergični na( preobčutljivi za) jod ali katerokoli drugo sestavino DaTSCAN- a (glejte poglavje 6:
Take special care with DaTSCAN
20 Bodite posebno pozorni pri uporabi DaTSCAN- a
DaTSCAN is not recommended for: • children or adolescents • people with moderate or severe problems with their kidneys or liver
DaTSCAN ni priporočljiv za: • otroke ali adolescente, ljudi, ki imajo zmerne ali hude težave z ledvicami ali jetri
DaTSCAN will always be used in a hospital or a similar place.
Uporabo, odlaganje in ravnanje z radioaktivnimi snovmi ureja stroga zakonodaja, zato se DaTSCAN vedno uporablja le v bolnišnicah in podobnih ustanovah.
Some medicines or substances can affect the way that DaTSCAN works.
Nekatera zdravila ali snovi lahko vplivajo na delovanje DaTSCAN- a.
These include: • buproprion • benzatropine • mazindol • sertraline • methylphenidate • phentermine • amfetamine • cocaine
Mednje sodijo: • buproprion, • benzatropin, • mazindol, • sertralin, • metilfenidat, • fentermin, • amfetamin, • kokain.
Other medicines used to treat Parkinson’ s disease (like levodopa) do not affect how DaTSCAN works.
Druga zdravila za zdravljenje Parkinsonove bolezni (na primer levodopa), ne bodo vplivala na delovanje DaTSCAN- a.
You can continue to take them.
Lahko jih jemljete še naprej.
The doctor may ask you to stop taking them for a short time before you receive DaTSCAN.
Zdravnik vas bo morda prosil, da jih za kratek čas, preden prejmete DaTSCAN, nehate jemati.
You should not have DaTSCAN if you are pregnant or think you may possibly be pregnant.
Nosečnost in dojenje DaTSCAN- a ne uporabljajte, če ste noseči ali mislite, da bi lahko bili noseči.
Tell your doctor if you think you might be pregnant.
Obvestite svojega zdravnika, če menite, da utegnete biti noseči.
If you are breast-feeding, your doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding.
Če dojite, bo zdravnik morda preložil uporabo DaTSCAN- a na pozneje ali pa vas bo prosil, da opustite dojenje. Ni znano, ali se ioflupan (123I) (zdravilna učinkovina DaTSCAN- a) izloča v človeško mleko.
It is not known whether ioflupane (123I) (the active substance in DaTSCAN) is passed into breast milk. • You should not breast-feed your child for 3 days after DaTSCAN is given. • Instead use formula feed for your child.
• Tri dni po prejetju DaTSCAN- a ne smete dojiti. • Namesto dojenja takrat uporabite mlečne nadomestke, ki so na voljo za hranjenje dojenčkov.
Express your breast milk regularly and throw away any breast milk you have expressed. • You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.
Mleko si v tem času redno izbrizgavajte in vse iztisnjeno mleko zavrzite. • Tako morate postopati tri dni zaporedoma, dokler se radioaktivne snovi ne izločijo iz telesa.
21 Driving and using machines
21 Pomembne informacije o nekaterih sestavinah DaTSCAN- a
DaTSCAN is not likely to affect your ability to drive or to use machines.
Pri uporabi DaTSCAN- a ste izpostavljeni nizki radioaktivnosti.
When DaTSCAN is used, you are exposed to small amounts of radioactivity. his exposure is less than in some types of X-ray investigation.
Ta izpostavljenost je manjša kot pri nekaterih vrstah rentgenskih pregledov.
Your doctor will always consider the possible risks and benefits of DaTSCAN.
Vaš zdravnik bo vedno pretehtal morebitna tveganja in koristi uporabe DaTSCAN- a.
DaTSCAN contains alcohol (ethanol).
DaTSCAN vsebuje alkohol (etanol).
Each dose contains up to 197mg alcohol.
Vsak odmerek vsebuje do 197 mg alkohola.
This is harmful for people with alcoholism, liver disease or epilepsy.
Škodljiv je za alkoholike, bolnike z jetrnimi obolenji ali epilepsijo.
HOW DaTSCAN IS USED
KAKO UPORABLJAMO DaTSCAN
Your doctor will decide the dose that is best for you.
Vaš zdravnik bo določil, kakšen odmerek je za vas najboljši.
Before you receive DaTSCAN, your doctor will ask you to take some tablets or liquid that contain iodine.
Preden prejmete DaTSCAN, vam bo zdravnik dal tablete ali tekočino, ki vsebuje jod.
DaTSCAN is given to you as an injection, usually into a vein in your arm.
DaTSCAN boste prejeli kot injekcijo, ponavadi v veno na roki.
The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.
Slikanje s kamero se ponavadi napravi v 3 do 6 urah po injiciranju DaTSCAN- a.
If you get more DaTSCAN than you should
Če dobite večji odmerek DaTSCAN- a, kot bi smeli
Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an overdose.
DaTSCAN vam bo dal zdravnik pod strogo nadzorovanimi pogoji, zato ni verjetno, da bi prejeli prevelik odmerek.
Your doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine.
Zdravnik vam bo priporočil, da pijete veliko tekočine in s tem pospešite izločanje zdravila iz telesa.
This is normal practice with medicines like DaTSCAN.
To je običajen postopek pri uporabi zdravil, kakršno je DaTSCAN.
POSSIBLE SIDE-EFFECTS
MOŽNI NEŽELENI UČINKI
Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi DaTSCAN neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common side- effects (affecting less than 1 person in 10) are headache, dizziness (vertigo), increased appetite and a brief irritating feeling similar to ants crawling over your skin (formication).
Med pogoste neželene učinke (ki se pojavijo pri manj kot pri 1 od 10 oseb) sodijo glavobol, omotičnost (vrtoglavica), povečan tek in kratkotrajen dražeč občutek, podoben mravljinčenju.
An uncommon side effect (affecting less than 1 person in 100) is intense pain on injection.
Občasno (pri manj kot 1 od 100 oseb) se pojavi intenzivna bolečina na mestu injiciranja.
This has been reported among patients receiving DaTSCAN into a small vein.
O tem so poročali pri bolnikih, ki so DaTSCAN prejeli v majhno veno.
The amount of radioactivity in the body from DaTSCAN is very small.
Količina radioaktivnosti v telesu zaradi DaTSCAN- a je zelo majhna.
HOW DaTSCAN IS STORED
KAKO SHRANJUJEMO DaTSCAN
• Keep out of the reach and sight of children. • Do not store above 25°C.
• Zdravilo shranjujte nedosegljivo otrokom!
22 • Do not freeze.
22 • Shranjujte pri temperaturi do 25 °C. • Ne zamrzujte.
The product label includes the correct storage conditions and the expiry date for the batch.
Oznaka na ovojnini navaja pravilne pogoje za shranjevanje in datum, do katerega je uporabna ta serija izdelka.
What DaTSCAN contains
Kaj vsebuje zdravilo DaTSCAN
• The active substance is ioflupane (123I). • The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.
Zdravilna učinkovina je ioflupan (123I). • • Pomožne snovi so ocetna kislina, natrijev acetat, etanol in voda za injiciranje.
DaTSCAN is supplied as a single, colourless, 10 ml glass vial containing either: • 185 MBq (Megabecquerel – the unit in which radioactivity is measured) of the active substance ioflupane (123I) in 2.5 ml of a sterile solution for intravenous injection, or • 370 MBq of ioflupane (123I) in 5.0 ml of a sterile solution for intravenous injection.
DaTSCAN je pakiran v posameznih brezbarvnih, steklenih, 10 mililiterskih vialah, ki vsebujejo: • 185 MBq (megabequerel – merska enota za radioaktivnost) učinkovine ioflupana (123I) v 2, 5 ml sterilne raztopine za intravensko injiciranje ali • 370 MBq ioflupana (123I) v 5, 0 ml sterilne raztopine za intravensko injiciranje.
Den Dolech 2 NL-5612 AZ, Eindhoven The Netherlands
Den Dolech 2 NL- 5612 AZ, Eindhoven Nizozemska
Č eská republika GE Healthcare (South Central Europe) Handels GmbH Branch Office Czech Republic Vyskocilova 1422/ 1a CZ 140 28 Praha 4 Tel: +420 224 446 179
24 Česká republika GE Healthcare (South Central Europe) Handels GmbH Branch Office Czech Republic Vyskocilova 1422/ 1a CZ 140 28 Praha 4 Tel: +420 224 446 179
Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel: +44 (0) 1494 54 40 00
25 Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel: +44 (0) 1494 54 40 00
This leaflet was last approved in MM/ YYYY
Navodilo je bilo odobreno MM/ LLLL
What is DepoCyte used for?
Za kaj se zdravilo DepoCyte uporablja?
DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the spinal fluid and the membranes that surround the brain and spinal cord (meninges).
Zdravilo DepoCyte se uporablja za zdravljenje limfomatoznega meningitisa: to je stanje, pri katerem so se tumorske celice limfoma deloma razširile v spinalno tekočino in na membrane, ki obdajajo možgane in hrbtenjačo (meninge).
DepoCyte should only be given by a doctor who has experience in the use of anti-cancer medicines.
Zdravilo DepoCyte lahko predpiše le zdravnik, ki ima izkušnje z zdravili proti raku.
DepoCyte is a ‘ depot’ injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly).
DepoCyte je injekcija „ na zalogo “ (vrsta injekcije, v kateri je zdravilo pripravljeno tako, da ga telo vsrkava zelo počasi).
The medicine must be injected directly into the spinal fluid (intrathecal injection: injection into the space that surrounds the spinal cord and the brain).
Zdravilo je treba vbrizgati neposredno v spinalno tekočino (intratekalna injekcija: vbrizganje v prostor, ki obdaja hrbtenjačo in možgane).
The patient should also receive a steroid medicine (dexamethasone) at the same time to help control some of the side effects of the medicine.
Bolnik mora prejeti tudi steroidno zdravilo (deksametazon).
DepoCyte is first given as a 50 mg injection every two weeks for the first 5 doses, followed by a further 50 mg dose 4 weeks later.
Prvih 5 odmerkov zdravila DepoCyte se na začetku daje kot 50 mg injekcija vsake 2 tedna, ki jim 4 tedne kasneje sledi še nadaljnji 50 mg odmerek.
This is then followed by maintenance doses of 50 mg every 4 weeks for a further 4 doses.
Nato sledijo 4 vzdrževalni odmerki po 50 mg vsake 4 tedne eden.
The dose can be decreased to 25 mg if the patient shows signs of neurotoxicity (such as headache, abnormal vision, or muscle weakness or pains).
Odmerek se nato lahko zmanjša na 25 mg, če bolnik kaže znake nevrotoksičnosti (kot so glavobol, nenormalen vid ali šibkost oziroma bolečine v mišicah).
The active substance in DepoCyte, cytarabine (also known as ara-C), is an anti-cancer agent that has been used since the 1970s.
Zdravilna učinkovina v zdravilu DepoCyte, citarabin (znan tudi kot ara- C), je učinkovina proti raku, ki se uporablja že od 1970- ih dalje.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the groups of the anti-metabolites.
Zdravilo je citotoksin (zdravilo, ki ubija deleče se celice, kakršne so rakaste celice), ki spada v skupino antimetabolitov.
Pyrimidine is part of the genetic material of cells (DNA and RNA).
Pirimidin je del genskega materiala celic (DNA in RNA).
In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the synthesis of DNA.
Citarabin v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri sintezi DNA.
As a result, cytarabine inhibits growth of tumour cells and eventually kills them.
Posledično citarabin zavira rast tumorskih celic in jih v končni fazi tudi ubije.
In DepoCyte, cytarabine is in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released.
V zdravilu DeopCyte je citarabin v posebni obliki: zdravilna učinkovina se nahaja v liposomih (majhnih maščobnih delcih), iz katerih se počasi sprošča.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has DepoCyte 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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo DepoCyte raziskano?
The effects of DepoCyte were first tested in experimental models before being studied in humans.
Učinki zdravila DepoCyte so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study was carried out in 35 patients and compared the intrathecal administration of DepoCyte with that of a standard formulation of cytarabine.
V glavni študiji so preučevali 35 bolnikov in primerjali intratekalno dajanje zdravila DepoCyte s standardno obliko citarabina.
The study measured how the patient responded to the treatment (no more cancer cells in the spinal fluid after treatment) and how their nerve disease (symptoms from their nervous system) progressed.
V študiji so merili odziv bolnikov na zdravljenje (nič več rakavih celic v spinalni tekočini po zdravljenju) ter kako je njihova živčna bolezen (simptomi iz njihovega živčnega sistema) napredovala.
What benefit has DepoCyte shown during the studies?
Kakšne koristi je zdravilo DepoCyte izkazalo med raziskavami?
13 of the 18 patients treated with DepoCyte responded to treatment as shown through elimination of cancer cells from their spinal fluid.
13 od 18 bolnikov se je odzvalo na zdravljenje, kar je bilo razvidno iz izločanja rakavih celic iz spinalne tekočine.
Among the 17 patients who received the standard formulation, 3 responded to treatment.
Med 17 bolniki, ki so prejemali standardno zdravljenje so se trije nanj odzvali.
However, there was no difference between the two medicines with regards to the time before the patient experienced a worsening of their nerve disease.
Vendar pa med obema zdraviloma ni bilo razlik, kar se tiče časa, preden se je bolniku poslabšala živčna bolezen.
The most common side effects (seen in between 1 in 10 and 1 in 4 treatment cycles) are headache, nausea (feeling sick), vomiting, fever, and back pain.
Najpogostejši neželeni učinki (opaženi pri 1 od 10 ter pri 1 od 4 ciklov zdravljenja) so glavobol, navzeja (občutek slabosti), bruhanje, povišana telesna temperatura in bolečine v hrbtu.
DepoCyte can cause arachnoiditis (an inflammation of the arachnoid, one of the membranes protecting the spine and the brain).
Zdravilo DepoCyte lahko povzroči arahnoiditis (vnetje arahnoide, ene od membrane, ki varujejo hrbtenjačo in možgane).