natgillin/translations-raw huggingface dataset:
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in: i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world
državah članicah EU za obdobje poročanja s številko serije, državah članicah EU skupaj in preostalem svetu.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s 114. členom dopolnjene Direktive 2001/ 83/ EC bo uradno sproščanje serij opravil državni laboratorij ali laboratorij, ki bo določen za ta namen.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile in case the Pandemic will be declared.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja med koristmi in tveganji, po razglašeni pandemiji.
Area Clinical
Področje Klinika
Description During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Opis Med pandemijo bo predlagatelj zbiral klinične podatke o varnosti in učinkovitosti cepiva s pandemičnim sevom in jih predajal CHMP v ovrednotenje.
Due date Depending on and after implementation of vaccine when first pandemic will take place.
Rok Odvisno od uporabe cepiva ob nastopu prve pandemije in kasneje, po prvi uporabi.
Pharmacovigilance
Odvisno od uporabe cepiva
Depending on and after implementation of vaccine when first pandemic will take place.
ob nastopu prve pandemije in kasneje, po prvi uporabi.
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
CELVAPAN suspenzija za injiciranje cepivo proti pandemični gripi z inaktiviranimi virusi, pridobljenimi iz celic Vero
Whole virus influenza vaccine, inactivated containing antigen of pandemic strain*:
Cepivo proti gripi z inaktiviranimi virusi, ki vsebuje antigen pandemičnega seva *:
7.5 microgram**
7, 5 mikrograma **
per 0.5 ml dose
na odmerek 0, 5 ml
* propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin
* razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** izraženo v mikrogramih hemaglutinina
20 multidose vials (10 doses per vial – 0.5 ml per dose)
Suspenzija za injiciranje 20 vial z več odmerki (10 odmerkov na vialo – 0, 5 ml na odmerek)
CELVAPAN suspension for injection (whole virion, Vero cell derived, inactivated) Pandemic influenza vaccine I. M.
CELVAPAN suspenzija za injiciranje cepivo proti pandemični gripi z inaktiviranimi virusi, pridobljenimi iz celic Vero i. m.
Multidose vial (10 doses of 0.5 ml pervial)
Viala z več odmerki (v viali je 10 odmerkov po 0, 5 ml)
BAXTER AG A-1221 Vienna Austria
BAXTER AG A– 1221 Dunaj Avstrija
19 PACKAGE LEAFLET:
19 NAVODILO ZA UPORABO:
Read all of this leaflet carefully before you start receiving this vaccine.
Pred cepljenjem natančno preberite navodilo za uporabo!
- Keep this leaflet.
Navodilo shranite.
Do not pass it on to others.
Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek,
please tell your doctor or pharmacist.
ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In this leaflet 1.
Navodilo vsebuje 1.
What CELVAPAN is and what it is used for 2.
Kaj je cepivo CELVAPAN in za kaj ga uporabljamo 2.
Before you receive CELVAPAN 3.
Kaj morate vedeti, preden boste cepljeni s cepivom CELVAPAN 3.
How CELVAPAN is given 4.
Kako uporabljati cepivo CELVAPAN 4.
How to store CELVAPAN 6.
Shranjevanje cepiva CELVAPAN 6.
WHAT CELVAPAN IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO CELVAPAN IN ZA KAJ GA UPORABLJAMO
It is used to prevent influenza (flu) in an officially declared pandemic.
CELVAPAN je cepivo, ki se uporablja za odrasle od 18. leta starosti naprej, za preprečevanje influence (gripe) v uradno razglašenih pandemičnih razmerah.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Pandemična gripa je vrsta gripe, ki se pojavi vsakih nekaj desetletij in se zelo hitro širi, prizadene pa večino držav in regij po svetu.
The symptoms (signs) of pandemic flu are similar to those of an “ ordinary” flu but are usually more severe.
Simptomi (znaki) pandemične gripe so podobni znakom » navadne « gripe, vendar so običajno hujši.
BEFORE YOU RECEIVE CELVAPAN
KAJ MORATE VEDETI, PREDEN BOSTE CEPLJENI S CEPIVOM CELVAPAN
Do not use CELVAPAN:
Ne uporabljajte cepiva CELVAPAN:
• if you previously had a serious allergic reaction (i. e. life-threatening) to CELVAPAN. • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
• če ste v preteklosti imeli hudo alergijsko reakcijo (smrtno nevarno) na cepivo CELVAPAN; • če ste alergični na katerokoli sestavino ali ostanke v sledeh v cepivu (formaldehid, Benzonaza, saharoza).
The active substance and other ingredients in CELVAPAN are listed in Section 6 at the end of the leaflet.
Učinkovina in pomožne snovi v cepivu CELVAPAN so navedene v 6. poglavju na koncu navodil za uporabo.
However, in a pandemic situation, your doctor may recommend to give the vaccine.
V pandemičnih razmerah vam bo zdravnik morda vseeno svetoval cepljenje s cepivom.
Take special care with CELVAPAN:
Bodite posebno pozorni pri cepljenju s cepivom CELVAPAN:
You should tell your doctor before vaccination • if you have a severe infection with a high temperature (over 38°C).
Zdravniku pred cepljenjem povejte, • če imate hudo okužbo in povišano temperaturo (nad 38°C).
A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with CELVAPAN. • if you have a poor immune response (as for example because of immunosuppressive therapy, e. g. corticosteroid treatments or chemotherapy for cancer);
Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika glede cepljenja s cepivom CELVAPAN; • če imate oslabljen imunski sistem (na primer zaradi imunosupresivnega zdravljenja z zdravili, kot so kortikosteroidi ali kemoterapija proti raku); • če ste naročeni za odvzem krvi, da se potrdi okužba z določenimi virusi.
In the first few weeks after vaccination with CELVAPAN the results of these tests may not be correct.
V prvih tednih po cepljenju s cepivom CELVAPAN izvidi teh preiskav morda ne bodo pravilni.
Tell the doctor requesting these tests that you have recently received CELVAPAN; • If you have a bleeding problem or bruise easily.
Povejte zdravniku, ki je naročil te preiskave, da ste bili pred kratkim cepljeni s cepivom CELVAPAN; • če imate težave s krvavitvami oz. strjevanjem krvi ali že pri rahlem udarcu nastanejo modrice.
There is no information on the use of CELVAPAN below 18 years of age.
20 O uporabi cepiva CELVAPAN pri osebah, mlajših od 18 let, ni podatkov.
In case of pandemic national recommendations will be followed.
Pri pandemiji gripe se upoštevajo državna priporočila.
Taking other medicines: • Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. • CELVAPAN should not be given at the same time as other vaccines.
Jemanje drugih zdravil • Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom. • Cepiva CELVAPAN se ne daje hkrati z drugimi cepivi.
You should be aware that the side effects may be intensified. • If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, CELVAPAN can still be given but your response to the vaccine may be poor. • CELVAPAN should not be given at the same time as immunoglobulins.
Pri tem se lahko okrepijo neželeni učinki. • Če jemljete zdravila, ki zmanjšajo imunost na okužbe, ali prejemate drugo vrsto terapije (radioterapijo), ki vpliva na imunski sistem, boste še vedno lahko cepljeni s cepivom CELVAPAN, vendar bo lahko vaš odziv na cepivo oslabljen. • Cepivo CELVAPAN se ne sme uporabljati hkrati z imunoglobulini.
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding.
Obvestite zdravnika, če ste noseči, če mislite, da ste noseči, če nameravate zanositi ali če dojite.
Your doctor will decide if you should receive CELVAPAN.
Zdravnik bo odločil, ali ste lahko cepljeni s cepivom CELVAPAN.
CELVAPAN may make you feel dizzy or sick which may affect your ability to drive or use machines.
Cepivo CELVAPAN lahko povzroči omotico ali slabost, kar lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji.
HOW CELVAPAN IS GIVEN
KAKO UPORABLJATI CEPIVO CELVAPAN
Adults from the age of 18 years and older will receive two injections of CELVAPAN.
Odrasli od 18. leta starosti naprej prejmejo dva odmerka cepiva CELVAPAN.
The time period between the first and the second injection must be at least three weeks.
Med prvim in drugim odmerkom morajo preteči vsaj trije tedni.
CELVAPAN is given as an injection into the muscle (usually in the upper arm).
Zdravnik vam bo cepivo CELVAPAN dal v obliki injekcije v mišico (po navadi v nadlaket).
Like all medicines, CELVAPAN can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo CELVAPAN neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In the clinical studies with CELVAPAN, most side effects were mild in nature and short term.
V kliničnih študijah cepiva CELVAPAN je bila večina neželenih učinkov blagih in kratkotrajnih.
The following side effects have been reported in clinical studies.
Pogostnost morebitnih neželenih učinkov, navedenih spodaj, je določena v skladu z naslednjim dogovorom:
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) 21 uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
zelo pogosti (pri več kot 1 od 10 ljudi) pogosti (pri 1 do 10 ljudeh od 100 ljudi) občasni (pri 1 do 10 ljudeh od 1. 000 ljudi) 21 redki (pri 1 do 10 ljudeh od 10. 000 ljudi) zelo redki (pri manj kot 1 osebi od 10. 000 ljudi) neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Very common: • pain at the injection site
Zelo pogosti: • bolečina na mestu injiciranja;
Common: • runny nose and sore throat, • headache, dizziness, vertigo (motion sickness) • sweating more than usual, • joint or muscle pain, • chills, fatigue (feeling tired), malaise (generally feeling unwell), fever, • tissue hardening, redness, swelling or bruising at the injection site
Pogosti: • izcedek iz nosu in vnetje žrela; • glavobol, omotica, vrtoglavica (kinetoza); • povečano potenje; • bolečine v sklepih ali mišicah; • mrzlica, utrujenost, slabo počutje, povišana telesna temperatura; • otrdelost tkiva, rdečina, oteklina ali modrica na mestu injiciranja.
Uncommon: • swollen glands, • insomnia (difficulty sleeping), restlessness, • impaired perception of touch, pain, heat and cold, sleepiness, • conjunctivitis (an inflammation of the eye), • sudden hearing loss, • reduced blood pressure, • shortness of breath, cough, congestion of the nose, • nausea, vomiting, diarrhoea, stomach pain, • rash, itching, • irritation at the injection site
Občasni: • otečene žleze; • nespečnost (težave pri spanju), nemirnost; • povečana občutljivost na dotik, bolečino, vročino in mraz, zaspanost; • konjunktivitis (vnetje očesa); • nenadna izguba sluha; • nižji krvni tlak,; • zadihanost, kašljanje, zamašen nos; • slabost, bruhanje, driska, bolečine v trebuhu; • kožni izpuščaj, srbenje; • draženje na mestu vbrizganja.
Other side effects which have occurred in the days or weeks after vaccination with flu vaccines include:
Drugi neželeni učinki, ki so se pojavili v dneh ali tednih po cepljenju proti gripi, so:
Uncommon: • Generalized skin reactions such as itching, hives or rash
Občasni • splošne kožne reakcije, kot so srbečica, koprivnica ali izpuščaj;
Rare: • Nerve pain (neuralgia) • Tingling and numbness • Fits • Transient low blood platelet count • Allergic reactions, in rare cases leading to shock (a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death)
Redki: • bolečina v živcu (nevralgija); • občutek mravljinčenja in odrevenelosti; • napadi; • prehodno nizko število trombocitov; • alergijske reakcije, ki redko vodijo do šoka (nevaren upad krvnega tlaka, ki lahko vodi do izgube zavesti, kome ali smrti, če ne ukrepamo.
Very rare: • Inflammation of blood vessels (vasculitis) with s transient kidney problems • Inflammation of the brain and spinal chord (encephalomyelitis) • Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face
Zelo redki: • vnetje žil (vaskulitis) s prehodnimi težavami z ledvicami; • vnetje možganov in hrbtenjače (encefalomielitis); • prehodno vnetje živcev, ki povzroča bolečino, šibkost in paralizo okončin ter se pogosto razširi na prsni koš in obraz.
HOW TO STORE CELVAPAN
SHRANJEVANJE CEPIVA CELVAPAN
Do not use CELVAPAN after the expiry date which is stated on the carton.
Cepiva CELVAPAN ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Store in a refrigerator (2°C - 8°C).
22 Shranjujte v hladilniku (2 °C – 8 °C).
What CELVAPAN contains
Kaj vsebuje cepivo CELVAPAN
Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*:
cepivo proti gripi z inaktiviranimi virusi, ki vsebuje antigen pandemičnega seva *:
* propagated in Vero cells (continuous cell line of mammalian origin) ** haemagglutinin
* razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** hemaglutinin
What CELVAPAN looks like and contents of the pack
Izgled cepiva CELVAPAN in vsebina pakiranja
CELVAPAN is an off-white, opalescent, translucent liquid.
Cepivo CELVAPAN je belkasta, opalescentna in prosojna tekočina.
1 pack of CELVAPAN contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
Eno pakiranje cepiva CELVAPAN vsebuje 20 vial z več odmerki s 5 ml suspenzije, za injiciranje 10 odmerkov.
Baxter AG Industriestrasse 67 A-1221 Vienna, Austria
Baxter AG Industriestrasse 67 A– 1221 Dunaj, Avstrija
Baxter AG Uferstrasse 15 A-2304 Orth/ Donau Austria
Baxter AG Uferstrasse 15 A- 2304 Orth/ Donau Avstrija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder given below:
23 Za vse morebitne nadaljnje informacije o tem zdravilu se obrnite na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
Pouet de Camilo, 2 E- 46394 Ribarroja del Turia (Valencia) Tel: + 34 96 2722800
Portugal España Baxter Médico Farmacêutica Lda Baxter S. L.
Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira, Edifício 10 P-2710-089 Sintra Tel: + 351 21 925 25 00
Sintra Business Park Pouet de Camilo, 2 Zona Industrial da Abrunheira, Edifício 10 E - 46394 Ribarroja del Turia (Valencia) P- 2710- 089 Sintra Tel: + 34 96 2722800 Tel: + 351 21 925 25 00
Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL-Blackrock, Dublin Tel: + 353 1 2065500
Slovenija Ireland Baxter d. o. o Baxter Healthcare Ltd Železna cesta 14 Unit 7 Deansgrange Industrial Estate SI- 1000 Ljubljana IRL- Blackrock, Dublin Tel.: + 386 1 420 16 80 Tel: + 353 1 2065500
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ H
Hhttp: // www. emea. europa. eu /
The following information is intended for medical or health care professionals only:
25 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Vsak odmerek cepiva 0, 5 ml posesajte v brizgo za injiciranje.
25 The vaccine should not be administered intravascularly.
Cepiva CELVAPAN ne smete injicirati v žilo.
Any unused vaccine or waste material should be disposed of in accordance with local requirements .”
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
EPAR summary for the public This document is a summary of the European Public Assessment Report (EPAR).
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
Ceplene is a solution for injection that contains the active substance histamine dihydrochloride (0.5 mg/ 0.5 ml).
Zdravilo Ceplene je raztopina za injiciranje, ki vsebuje zdravilno učinkovino histamin dihidroklorid (0, 5 mg/ 0, 5 ml).
Ceplene is used in combination with interleukin-2 (an anticancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Zdravilo Ceplene uporabljamo v kombinaciji z interlevkinom- 2 (zdravilom proti raku) kot vzdrževalno zdravljenje pri odraslih z akutno mieloidno levkemijo (AML), vrsto raka, ki prizadene bele krvničke.
It is used during the patients’ first ‘ remission’ (a period without symptoms of the disease after the first course of treatment).
Uporablja se ob prvi remisiji (obdobju brez simptomov bolezni po prvemu zdravljenju).
Because the number of people with AML is low, the disease is rare, and Ceplene was designated as an ‘ orphan medicine’ (a medicine used in rare disease) on 11 April 2005.
Ker je število bolnikov z AML majhno, velja ta bolezen za redko, zato je bilo zdravilo Ceplene dne 11. aprila 2005 določeno kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
The recommended dose of Ceplene is a 0.5-mg injection under the skin, twice a day, one to three minutes after an interleukin-2 injection.
Priporočeni odmerek zdravila Ceplene je 0, 5 mg, ki se vbrizga podkožno dvakrat dnevno, eno do tri minute po vbrizganju interlevkina- 2.
Ceplene and interleukin-2 are given for 10 cycles.
Zdravili Ceplene in interlevkin- 2 se dajeta 10 ciklov.
The first three cycles consist of three weeks of treatment, followed by a three-week rest period.
Prvi trije cikli so sestavljeni iz treh tednov zdravljenja, ki jim sledi 3- tedensko obdobje brez zdravljenja.
The following seven cycles consist of three weeks of treatment, followed by a six-week rest period.
Naslednjih sedem ciklov je sestavljenih iz treh tednov zdravljenja, ki jim sledi 6- tedensko obdobje brez zdravljenja.
When Ceplene is first given, the patient ’ s blood pressure, heart rate and lung function must be monitored.
Pri prvemu dajanju zdravila Ceplene je treba spremljati krvni tlak, srčni utrip in delovanje pljuč.
Depending on the patient ’ s response to treatment and side effects, the treatment may be suspended or the dose adjusted.
Glede na odziv bolnika na zdravljenje in stranske učinke lahko zdravljenje prekinemo ali prilagodimo odmerek.
Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (tummy).
Vsako injekcijo zdravila Ceplene je treba vbrizgati počasi, v trajanju od petih do 15 minut in na drugem mestu kot injekcijo interlevkina- 2, najbolje v stegno ali abdomen (trebuh).
Ceplene should be used with caution in patients who have severe problems with their kidneys or moderate to severe problems with their liver.
Zdravilo Ceplene je treba uporabljati previdno pri bolnikih, ki imajo hude težave z ledvicami ali zmerne do hude težave z jetri.
Ceplene is not recommended for use in patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Zdravilo Ceplene se ne priporoča za bolnike do 18. leta starosti zaradi nezadostnih informacij o varnosti in učinkovitosti v tej starostni skupini.
This means that it alters the activity of the immune system (the body ’ s natural defences).
To pomeni, da spremeni aktivnost imunskega sistema (naravnega obrambnega mehanizma telesa).
Histamine is a naturally- occurring substance in the body that is involved in many processes.
Histamin je naravno prisotna snov v telesu, ki sodeluje v mnogo procesih.
In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Predvideva se, da pri zdravljenju AML ščiti celice imunskega sistema pred poškodbami.
When Ceplene 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
S tem se poveča učinkovitost interlevkina- 2, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Če zdravilo Ceplene uporabljamo sočasno z interlevkinom- 2, pomaga imunskemu sistemu uničevati levkemične celice, ki lahko ostanejo v telesu med remisijo.
This can increase the length of time until AML comes back.
S tem se lahko podaljša čas do ponovnega pojava AML.
The effects of Ceplene were first tested in experimental models before being studied in humans.
Učinki zdravila Ceplene so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Because histamine is a known substance, the company also presented data from the published literature.
Ker je histamin znana snov, je družba predstavila tudi podatke iz izdane literature.
The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Učinkovitost zdravila Ceplene so raziskovali v eni glavni študiji, ki je vključevala 320 odraslih z AML v remisiji po zdravljenju zaradi levkemije.
Ceplene was given in combination with interleukin-2 and compared with no treatment.
Zdravilo Ceplene so dajali v kombinaciji z interlevkinom- 2 in učinke takega zdravljenja primerjali z učinki pri bolnikih, ki niso bili zdravljeni.
The combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died: in the patients in their first complete remission, the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Pri bolnikih v prvi popolni remisiji se je povprečni čas brez bolezni podaljšal z 291 dni brez zdravljenja na 450 dni po zdravljenju z zdravilom Ceplene in interlevkinom- 2.
No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Pri bolnikih v drugi ali kasnejši remisiji niso opazili nikakršnega učinka zdravila Ceplene in interlevkina- 2.