natgillin/translations-raw huggingface dataset:
38 During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/ or throat, sore throat, low or increase in blood pressure, rapid heart beat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating.
37 Med infuzijo zdravila Caelyx se lahko pojavijo naslednje reakcije: rdečica obraza, težko dihanje, glavobol, mrzlica, bolečine v hrbtu, stiskanje v prsih in/ ali žrelu, vnetje žrela, nizek ali zvišan krvni tlak, hiter srčni utrip, zabuhlost obraza, zvišana telesna temperatura, omotica, slabost, prebavne motnje, srbenje, izpuščaj in znojenje.
In very rare cases, seizures (convulsions) have occurredStinging or swelling of the skin at the site of injection may also occur.
Pojavi se lahko tudi občutek zbadanja ali otekanje kože na mestu injiciranja.
- you get reddening painful skin on your hands and feet,
- vam koža na dlaneh in stopalih pordi in vas boli,
- you get painful reddening of the skin and/ or blisters on the body or in the mouth,
- se lahko pojavi boleča pordelost kože in/ ali mehurji na telesu ali v ustih,
- you get heart problems,
- se pojavijo težave s srcem,
- you get mouth sores,
- se pojavijo razjede v ustih,
- you develop a fever or any other sign of an infection,
- se vam zviša telesna temperatura ali se pojavi kakšen drug znak okužbe,
- you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or
- se pri vas nenadno pojavijo težave z dihanjem ali ostre bolečine v prsih, ki se lahko poslabšajo z
coughing,
globokim dihanjem ali kašljanjem,
- you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain
- se pojavi otekanje, občutek toplote ali bolečnost v globokih tkivih nog, včasih skupaj z bolečino,
which gets worse when you stand or walk.
ki se poslabša s stanjem ali hojo.
- redness, swelling and sores on the palms of your hands and feet.
- pordelost ter rane ali otekanje dlani in stopal.
These effects have been seen
V
In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely.
hujših primerih lahko ti učinki motijo določene vsakodnevne dejavnosti in lahko trajajo kar 4 tedne ali celo dlje, preden popolnoma minejo.
The doctor may wish to delay the start and/ or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below);
Zdravnik lahko preloži začetek naslednjega ciklusa in/ ali zmanjša odmerek zdravila pri naslednjem ciklusu (glejte točko Načini za preprečevanje in zdravljenje sindroma dlani in stopal, spodaj);
- pain or sores in mouth or throat, nausea, vomiting, stomach pains, diarrhoea, constipation, oral
- bolečine ali rane v ustih ali žrelu, slabost, bruhanje, želodčne bolečine, driska, zaprtje, soor v
thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, loss of appetite, weight loss and tongue inflammation;
ustih (glivična okužba v ustih), ranice v nosni sluznici, krvavitev iz nosa, herpesne ranice, izguba teka, hujšanje in vnetje jezika;
- decrease in the number of white blood cells, which can increase the chances of infections.
Anemija (zmanjšanje
Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding.
števila eritrocitov) lahko povzroči utrujenost, zmanjšano število trombocitov v krvi pa lahko poveča nevarnost za krvavitve.
Laboratory values related to the function of the liver may either increase or decrease while on Caelyx.
Med zdravljenjem z zdravilom Caelyx se lahko spremenijo tiste vrednosti v izvidih laboratorijskih preiskav, ki se nanašajo na delovanje jeter.
From a clinical study in patients with AIDS-KS comparing Caelyx against another treatment (bleomycin/ vincristine), there may be a higher chance of some infections with Caelyx.
Klinična raziskava pri bolnikih z aidsom in Kaposijevem sarkomom, v kateri so zdravilo Caelyx primerjali z drugim načinom zdravljenja (z bleomicinom in vinkristinom), je pokazala, da je nevarnost za pojav nekaterih okužb lahko večja pri prejemanju zdravila Caelyx.
Some of these effects may be related to your disease and not to Caelyx;
Nekateri od teh učinkov so lahko tudi posledica same bolezni in ne zdravila Caelyx;
- general feeling of tiredness, sleepiness, confusion, dizziness, weakness, bone pain, breast pain,
- splošen občutek utrujenosti, zaspanost, zmedenost, omotica, oslabelost, bolečine v kosteh,
muscle pain, leg cramps or swelling, general swelling, inflammation of the retina (the light- detecting membrane of the eye), increased tear production, blurred vision, feeling of pins and needles or pain in hands and feet;
dojkah in mišicah, mišični krči v nogah ali otekanje nog, splošno otekanje, vnetje očesne mrežnice (očesna ovojnica, s katero zaznavamo svetlobo), povečano nastajanje solz, zameglen vid, mravljinčenje ali bolečine v dlaneh in stopalih;
- hair loss, inflammation of hair follicles, scaly skin, inflammation or rash, abnormal skin
- izpadanje las in dlak, vnetje lasnih mešičkov, luskasta koža, vnetje ali izpuščaji, nenormalna
pigmentation (colouring), and nail disorder;
pigmentacija (obarvanje) kože in motnje nohtov;
- heart problems, e. g., irregular heart beat, enlarged blood vessels;
- težave s srcem, npr. nereden srčni utrip, razširjenje žil;
- fever, increased temperature or any other sign of infection which may be related to your disease;
- vročica, zvišana telesna temperatura ali kakšen drug znak okužbe, ki je lahko povezana z vašo
- respiratory problems, i. e., difficulty in breathing or coughing which may be linked to infections
- težave z dihali, npr. težko dihanje ali kašljanje, ki je lahko povezano z okužbami, ki ste jih
you have caught as a result of your disease;
dobili zaradi svoje bolezni;
- if you have previously had skin reactions, i. e., pain, redness and dryness of skin, during
- če ste pred tem že imeli kožne reakcije, npr. bolečine, pordelost in suhost kože med obsevanjem
treatment with radiotherapy, this may also happen with Caelyx.
(radioterapijo), se lahko te ponovijo med zdravljenjem z zdravilom Caelyx.
Other side effects that may occur with a combination of Caelyx and bortezomib include:
38 Med druge neželene učinke, ki se lahko pojavijo pri uporabi kombinacije zdravila Caelyx in bortezomiba, sodijo:
- joint pain, decreased or abnormal sensation to stimulation, inflammation of the cornea, redness
- sklepne bolečine, zmanjšan ali nenormalen občutek pri stimulaciji, vnetje roženice, pordelost
of the eye, redness of the scrotum.
očesa, pordelost mošnje pri moškem.
39 When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Pri samostojni uporabi zdravila Caelyx je verjetnost, da se bodo pojavili nekateri od teh učinkov, manjša, drugi pa se sploh ne pojavljajo.
Strategies to prevent and treat hand-foot syndrome:
Načini za preprečevanje in zdravljenje sindroma dlani in stopal:
Every day for 4-7 days beginning immediately after you have received Caelyx:
Vsak dan še 4 do 7 dni takoj po prejemu zdravila Caelyx:
- soak hands and/ or feet in basins of cold water when possible (e. g. while watching television,
- namakajte dlani in/ ali stopala v posodi z mrzlo vodo, kadar je le mogoče (npr. med gledanjem
reading, or listening to the radio);
televizije, branjem ali poslušanjem radia),
- keep hands and feet uncovered (no gloves, socks, etc.);
- roke in stopala naj bodo nepokriti (brez rokavic, nogavic itd.),
- stay in cool places;
- zadržujte se na hladnih mestih,
- take cool baths during hot weather;
- v vročem vremenu si privoščite hladne kopeli,
- avoid vigorous exercise that might cause trauma to the feet (e. g. jogging);
- izogibajte se intenzivni telesni vadbi, pri kateri bi si lahko poškodovali stopala (npr. jogging),
- avoid exposure of skin to very hot water (e. g. jacuzzis, saunas);
- ne izpostavljajte kože zelo vroči vodi (npr. v kopeli z mehurčki ali savni),
- avoid tight fitting footwear or high-heeled shoes.
- ne nosite tesno prilegajočih se čevljev ali čevljev z visoko peto.
Pyridoxine (Vitamin B6):
Piridoksin (vitamin B6):
- Vitamin B6 is available without prescription.
- Vitamin B6 je na voljo brez recepta.
- Take 50-150 mg daily beginning at the first signs of redness or tingling.
- Ob prvih znakih pordelosti ali mravljinčenja začnite jemati od 50 do 150 mg piridoksina na dan.
HOW TO STORE CAELYX
SHRANJEVANJE ZDRAVILA CAELYX
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Če ga ne uporabimo takoj, je tako za dolžino kot za pogoje shranjevanja zdravila pred uporabo odgovoren uporabnik, vendar čas shranjevanja ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C.
Partially used vials must be discarded.
Delno porabljene viale moramo zavreči.
Do not use Caelyx after the expiry date which is stated on the label and carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
Do not use Caelyx if you notice that it shows evidence of precipitation or any other particulate matter.
Ne uporabljajte zdravila Caelyx, če opazite znake obarjanja ali če vsebuje zdravilo kakršnekoli druge vidne delce.
What Caelyx contains
Kaj vsebuje zdravilo Caelyx
- The active substance is doxorubicin hydrochloride.
- Zdravilna učinkovina je doksorubicinijev klorid.
One ml of Caelyx contains 2 mg of
En ml zdravila Caelyx vsebuje 2 mg
doxorubicin hydrochloride in a pegylated liposomal formulation.
doksorubicinijevega klorida v pegiliranem liposomskem pripravku.
- The other ingredients are α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω -
- Pomožne snovi so α - (2 - [1, 2- distearoil- sn- glicero( 3) fosfooksi] etilkarbamoil) - ω -
methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
metoksipoli( oksietilen) - 40 natrijeva sol, popolnoma hidrogeniran sojin fosfatidilholin, holesterol, amonijev sulfat, saharoza, histidin, voda za injekcije, klorovodikova kislina in natrijev hidroksid.
Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).
Caelyx 2 mg/ ml koncentrat za raztopino za infundiranje: viale, ki vsebujejo po 10 ml (20 mg) ali 25 ml (50 mg) zdravilne učinkovine.
40 The solution for infusion is sterile, translucent and red.
Raztopino za infundiranje je sterilna, prosojna in rdeče barve.
SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
SP Europe, Rue de Stalle 73, B- 1180 Bruxelles, Belgija
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.
V., Industriepark 30, B- 2220 Heist- op- den- Berg, Belgija.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
42 The following information is intended for medical or healthcare professionals only (see section 3):
41 Naslednje informacije so namenjene samo zdravstvenemu osebju (glejte poglavje 3):
Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx.
Ker Caelyx ne vsebuje nobenega konzervansa ali bakteriostatika, mora biti postopek opravljen strogo aseptično.
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ ml) glucose solution for infusion prior to administration.
Ustrezni odmerek zdravila Caelyx morate pred dajanjem razredčiti v 5% (50 mg/ ml) raztopini glukoze za infundiranje.
For doses < 90 mg, dilute Caelyx in 250 ml, and for doses ≥ 90 mg, dilute Caelyx in 500 ml.
Za odmerke < 90 mg razredčite Caelyx v 250 ml, za odmerke ≥ 90 mg pa v 500 ml.
To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/ minute.
Da bi kar najbolj zmanjšali nevarnost infuzijskih reakcij, hitrost dajanja začetnega odmerka ne sme presegati 1 mg/ minuto.
In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows:
V raziskavi raka dojk so pri bolnicah z infuzijsko reakcijo dovolili naslednjo prilagoditev infundiranja:
5% of the total dose was infused slowly over the first 15 minutes.
5% celotnega odmerka so infundirali počasi v prvih 15 minutah.
If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/ or short acting corticosteroid) and restart at a slower rate.
Če se pri bolniku pojavijo zgodnji simptomi ali znaki infuzijske reakcije, infuzijo takoj prekinite, mu dajte ustrezno premedikacijo (antihistaminik in/ ali kratkodelujoči kortikosteroid) in nato infuzijo nadaljujte z manjšo hitrostjo.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What is Cancidas?
Kaj je zdravilo Cancidas?
Cancidas is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Cancidas je prašek, namenjen za pripravo raztopine za infundiranje (dajanje v veno).
What is Cancidas used for?
Za kaj se zdravilo Cancidas uporablja?
Cancidas is an antifungal medicine.
Cancidas je protiglivično zdravilo.
It is used to treat adults, adolescents and children with: • invasive candidiasis (a type of fungal infection due to Candida); • invasive aspergillosis (another type of fungal infection due to Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines); • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile (feverish) and neutropenic (lacking white blood cells).
Uporablja se za zdravljenje odraslih, mladostnikov in otrok z: • invazivno kandidiozo (vrsto glivične okužbe, ki jo povzroča Candida sp.); • invazivno aspergilozo (drugo vrsto glivične okužbe, ki jo povzroča Aspergillus sp.), če se bolnik ne odziva na amfotericin B ali itrakonazol (drugi protiglivični zdravili) ali ju ne prenaša; • domnevnimi glivičnimi okužbami (npr. zaradi Candida ali Aspergillus), če je bolnik febrilen in nevtropeničen (mu primanjkuje belih krvničk).
This is known as ‘ empirical treatment’, which means that the treatment is started based on an observation of the patient before the doctor has a confirmation of the infection.
Temu pravimo „ empirično zdravljenje “, kar pomeni, da se zdravljenje začne na podlagi opazovanja bolnika, preden zdravnik lahko zagotovo potrdi okužbo.
How is Cancidas used?
Kako se Cancidas uporablja?
Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Zdravljenje z zdravilom Cancidas mora začeti zdravnik z izkušnjami z zdravljenjem invazivnih glivičnih okužb.
Cancidas must be made up into a solution before use, using a diluent that does not contain glucose.
Pred uporabo je treba s pomočjo tekočine, ki ne vsebuje glukoze, pripraviti raztopino zdravila Cancidas.
It is given once a day by slow infusion lasting about one hour.
Zdravilo se daje enkrat dnevno s počasno infuzijo, ki traja približno eno uro.
In adults, treatment starts with a 70 mg loading dose, followed by a daily 50 mg dose, or 70 mg if the patient weighs more than 80 kg.
Pri odraslih se zdravljenje začne s 70 mg udarnim odmerkom, ki mu sledi 50- miligramski dnevni odmerek ali 70- miligramski dnevni odmerek; če bolnik tehta več kot 80 kg.
In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the child ’ s height and weight).
Pri bolnikih, starih od 12 mesecev do 17 let, je odmerek odvisen od telesne površine (izračunane na podlagi otrokove višine in mase).
Cancidas should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Zdravilo Cancidas je treba pri otrocih, mlajših od 12 mesecev, uporabljati previdno, saj zdravilo v tej starostni skupini ni bilo zadostno raziskano.
Treatment is continued for up to two weeks after the infection has been cured.
Zdravljenje se nadaljuje dva tedna po ozdravitvi okužbe.
The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘ echinocandins’.
Zdravilna učinkovina v zdravilu Cancidas, kaspofungin, sodi v skupino protiglivičnih zdravil, znanih kot ehinokandini.
It works by interfering with the production of a component of the fungal cell wall called ‘ glucan polysaccharide’, which is necessary for the fungus to continue living and growing.
Deluje tako, da posega v tvorbo ene od sestavin celične stene glive, ki se imenuje glukan polisaharid in je nujna, da bi lahko gliva živela in rasla.
Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Celice gliv, ki so izpostavljene 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. unable to grow.
Reproduction is authorised provided the source is acknowledged. zdravilu Cancidas, imajo nepopolne ali okvarjene celične stene, zaradi česar so občutljive in ne morejo rasti.
The list of fungi against which Cancidas is active can be found in the Summary of Product Characteristics (also part of the EPAR).
Seznam gliv, proti katerim zdravilo Cancidas učinkuje, najdete v povzetku glavnih značilnosti zdravila (ki je prav tako sestavni del EPAR).
How has Cancidas been studied?
Kako je bilo zdravilo Cancidas raziskano?
Cancidas has been studied in five main studies.
Zdravilo Cancidas so proučevali v petih glavnih študijah.
Three studies looked at the effects of Cancidas in the treatment of invasive candidiasis or aspergillosis: one study involved 239 adults with invasive candidiasis, another involved 69 adults with invasive aspergillosis, and the third involved 49 patients aged between six months and 17 years with either candidiasis or aspergillosis.
V treh študijah so raziskovali učinke zdravila Cancidas pri zdravljenju invazivne kandidioze ali aspergiloze: v eno študijo je bilo vključenih 239 odraslih z invazivno kandidiozo, v drugo 69 odraslih z invazivno aspergilozo, v tretjo pa 49 bolnikov, starih od šest mesecev do 17 let, s kandidiozo ali aspergilozo.
Cancidas was compared with amphotericin B given into a vein in the study of adults with invasive candidiasis.
Učinke zdravila Cancidas so v študiji odraslih z invazivno kandidiozo primerjali z učinki infundiranja amfotericina B v veno.
For the empirical treatment of neutropenic febrile patients, Cancidas has been compared with amphotericin B in two studies: one involving 1,111 adults and another involving 82 patients aged between two and 17 years.
Pri empiričnem zdravljenju nevtropeničnih febrilnih bolnikov so zdravilo Cancidas primerjali z amfotericinom B v dveh študijah: ena je vključevala 1 111 odraslih in druga 82 bolnikov, starih od dveh do 17 let.
In all five studies, the main measure of effectiveness was the number of patients who responded to treatment.
V vseh petih študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se odzvali na zdravljenje.
This is based on the improvement of their symptoms, as well as other criteria, such as elimination of the fungus from samples taken from the patients.
To je temeljilo na izboljšanju simptomov, kakor tudi na drugih merilih, kot je izločanje gliv iz vzorcev, ki so bili odvzeti bolnikom.
What benefit has Cancidas shown during the studies?
Kakšne koristi je zdravilo Cancidas izkazalo med študijami?
In invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
Pri invazivni kandidiozi je bil pri 73% bolnikih, zdravljenih z zdravilom Cancidas, odziv ocenjen kot ugoden (80 od 109), v primerjavi z 62% bolnikov, ki so prejemali amfotericin B (71 od 115).
In invasive aspergillosis, 41% of the adults had a favourable response at the end of the study (26 out of 63).
Pri invazivni aspergilozi je bil ob koncu študije pri 41% bolnikov odziv ugoden (26 od 63).
Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53).
Od odraslih, ki se niso odzvali na drugo zdravljenje, se jih je 36% odzvalo na zdravilo Cancidas (19 od 53).
Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Med tistimi, ki niso prenašali drugega zdravljenja, se jih je 70% odzvalo na zdravilo Cancidas (7 od 10).
Similar responses were seen in children and adolescents:
Odzivi na zdravljenje z zdravilom Cancidas pri otrocih in mladostnikih so bili podobni:
50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
50% tistih z invazivno kandidiozo (5 od 10) in 81% tistih z invazivno asperigilozo (30 od 37).
In the empirical treatment of febrile neutropenic patients, Cancidas was as effective as amphotericin B.
Pri empiričnem zdravljenju nevtropeničnih febrilnih bolnikov je bilo zdravilo Cancidas tako učinkovito kot amfotericin B.
In the adult study, 34% of both groups of adults had a favourable response.
V študiji odraslih se je ugodno odzvalo 34% bolnikov iz obeh skupin odraslih.
Similar results were seen in the study of children and adolescents.
Podobni so bili izidi pri študiji otrok in mladostnikov.
What is the risk associated with Cancidas?
Kakšna tveganja so povezana z zdravilom Cancidas?
The most common side effect with Cancidas (seen in more than 1 patient in 10) is fever.
Najpogostejši neželeni učinek (opažen pri 1 izmed 10 bolnikov) pri zdravilu Cancidas je bila povišana telesna temperatura.
For the full list of all side effects reported with Cancidas, see the Package Leaflet.
Za celoten seznam vseh neželenihučinkov, o katerih so poročali pri uporabi zdravila Cancidas glejte navodilo za uporabo.
Cancidas should not be used in people who may be hypersensitive (allergic) to caspofungin or any of the other ingredients.
Zdravila Cancidas ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kaspofungin ali katero koli drugo sestavino zdravila.
Why has Cancidas been approved?
Zakaj je bilo zdravilo Cancidas odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Cancidas’ s benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and empirical therapy for presumed fungal infections, in adult or paediatric patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cancidas pri zdravljenju invazivne kandidioze ali aspergilioze ter empirični terapiji zaradi domnevnih glivičnih okužb pri odraslih ali pediatričnih bolnikih večje od z njim povezanih tveganj.
The Committee recommended that Cancidas be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Cancidas odobri dovoljenje za promet.
Cancidas was originally authorised under ‘ Exceptional Circumstances’, because limited information was available at the time of approval.
Zdravilo Cancidas je bilo prvotno odobreno „ v izjemnih okoliščinah “, saj so bile ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 29 September 2006.
Ker je družba posredovala zahtevane dodatne informacije, so „ izjemne okoliščine “ prenehale 29. septembra 2006.
Other information about Cancidas:
Druge informacije o zdravilu Cancidas: