natgillin/translations-raw huggingface dataset:
Bowen's disease, basal cell carcinoma, keratoacanthoma, malignant melanoma) in patients with actinic keratosis treated with ingenol mebutate, the MAH should conduct and submit the results of a cohort study comparing patients treated with ingenol mebutate with patients exposed to other actinic keratosis treatments.
Za preučitev stopnje malignih obolenj kože (skvamoznega karcinoma, morbus Bowen, bazalnoceličnega karcinoma, keratoakantoma, malignega melanoma) pri bolnikih z aktinično keratozo, zdravljenih z ingenolmebutatom, mora imetnik dovoljenja za promet z zdravilom izvesti kohortno študijo, v kateri bo primerjal bolnike, zdravljene z ingenolmebutatom, in bolnike, izpostavljene drugim zdravilom za zdravljenje aktinične keratoze, ter predložiti rezultate študije.
Complete Clearance Ratea
Stopnja popolne ozdravitvea
In another study, 329 patients who were initially treated with cryotherapy on the face/scalp were randomised after three weeks to either Picato 150 mcg/g (n=158) or vehicle (n=150) for 3 days in the same area.
V drugi študiji so 329 bolnikov, ki so se najprej zdravili s krioterapijo obraza/lasišča, po 3 tednih randomizirali na 3-dnevno zdravljenje istega predela z zdravilom Picato 150 µg/g (n = 158) ali vehiklom (n = 150).
a Complete clearance rate is defined as the proportion of patients with no (zero) clinically visible actinic keratosis lesions in the treatment area.
a Stopnja popolne ozdravitve je opredeljena kot delež bolnikov brez (tj. z nič) klinično vidnih lezij zaradi aktinične keratoze na zdravljenem predelu.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
After using this medicine the skin where you apply it is likely to get red, peel and have scabs.
Po uporabi tega zdravila obstaja verjetnost, da se na mestu nanosa pojavijo rdečina, luščenje ali kraste.
- The active substance is ingenol mebutate.
- Učinkovina je ingenolmebutat.
Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato (see section 4.8).
Pričakuje se, da se bodo po nanosu zdravila Picato na koži pojavili lokalni odzivi, kot so eritem, prhljaj/luščenje in nastajanje krast (glejte poglavje 4.8).
Picato 500 micrograms/gram gel
Picato 500 mikrogramov/gram gel
The incidence of severe local skin responses that occurred at an incidence >1% in both the ‘face/scalp' and the ‘trunk/extremities', respectively are: application site erythema (24% and 15%), application site exfoliation (9% and 8%), application site scab (6% and 4%), application site swelling (5% and 3%) and application site pustules (5% and 1%).
Hudi lokalni odzivi na koži pri zdravljenju »obraza/lasišča« oziroma »trupa/okončin«, pri katerih je bila incidenca > 1-odstotna, so: eritem na mestu uporabe (24 % oz. 15 %), luščenje kože na mestu uporabe (9 % oz. 8 %), krasta na mestu uporabe (6 % oz. 4 %), oteklina mesta uporabe (5 % oz. 3 %) in pustule na mestu uporabe (5 % oz. 1 %).
In a double-blind, vehicle-controlled study to evaluate systemic exposure, Picato 500 mcg/g, from 4 tubes, was applied to a 100 cm2 contiguous treatment area daily for 2 consecutive days.
V dvojno slepi, z vehiklom nadzorovani študiji za ocenitev sistemske izpostavljenosti so zdravilo Picato 500 µg/g iz 4 tub 2 zaporedna dneva nanašali na sklenjeno zdravljeno mesto velikosti 100 cm2.
Risks to humans receiving cutaneous treatment with ingenol mebutate are considered unlikely as Picato is not absorbed systemically.
Tveganja za ljudi, ki prejemajo kožno zdravljenje z ingenolmebutatom, so malo verjetna, saj se zdravilo Picato ne absorbira sistemsko.
Rare side effects, may affect up to 1 in 1000 people:
Redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
On the treatment area: - Scarring
Na zdravljenem mestu: - brazgotinjenje
Nervous system disorders
Bolezni živčevja glavobol pogosti
Cutaneous use
Dermalna uporaba
Patients in whom the first treatment course led to complete clearance were seen at 26 and 44 weeks and randomised to a second treatment course if they had a recurrence in the field.
Bolnike, pri katerih so s prvim krogom zdravljenja dosegli popolno ozdravitev, so ponovno pregledali v 26. in 44. tednu ter jih randomizirali na dodaten krog zdravljenja,
SCC in the treatment area was reported in no patients (0 of 184 patients previously treated with ingenol mebutate gel) in the three prospective, observational long term 1 year follow-up studies.
V treh prospektivnih, opazovalnih dolgotrajnih študijah z 1-letnim spremljanjem niso pri nobenem od bolnikov opazili skvamoznega karcinoma (0 od 184 bolnikov, predhodno zdravljenih z gelom z ingenolmebutatom).
Administration of Picato is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised.
Nanašanje gela Picato se ne priporoča, dokler koža, zdravljena s predhodnimi zdravili ali kirurško, ni zaceljena.
Package leaflet: Information for the patient Picato 500 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring.
Navodilo za uporabo Picato 500 mikrogramov/gram gel ingenolmebutat (ingenoli mebutas) Za to zdravilo se izvaja dodatno spremljanje varnosti.
If more than half of the treatment area is located in the lower part of the neck, Picato 500 mcg/g gel should be used at the posology for trunk and extremities.
Če je več kot polovica zdravljenega mesta na spodnjem delu vratu, je treba uporabiti gel Picato 500 µg/g v odmerku za trup in okončine.
d Patients in whom the first treatment course did lead to complete clearance and who had a recurrence in the treatment area at either week 26 or 44.
d Bolniki, pri katerih so v prvem krogu zdravljenja dosegli popolno ozdravitev, vendar so v 26. ali 44. tednu ugotovili ponovitev bolezni.
Package leaflet: Information for the patient Picato 150 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring.
Navodilo za uporabo Picato 150 mikrogramov/gram gel ingenolmebutat (ingenoli mebutas) Za to zdravilo se izvaja dodatno spremljanje varnosti.
Uncommon side effects, may affect up to 1 in 100 people:
Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
Patients continued in the studies for an 8 week follow-up period during which they returned for clinical observations and safety monitoring.
tedenskim spremljanjem, med katerim so bili klinično opazovani, in spremljani glede varnosti.
Patients should be instructed to wash their hands with soap and water, immediately after applying Picato, and between topical applications if two different areas require different strengths.
Bolnikom naročite, naj si po nanosu zdravila Picato in med lokalnimi nanosi, če je treba na dveh različnih mestih uporabiti različne jakosti gela, nemudoma umijejo roke z milom in vodo.
This side effect is uncommon.
Ta neželeni učinek se pojavlja občasno.
Picato 150 micrograms/gram gel
Picato 150 mikrogramov/gram gel
Other side effects: - Swelling of the area around the eye (periorbital oedema) - Swelling (oedema) of your eye lid - Headache
Drugi neželeni učinki: - otekline v predelu okoli oči (periorbitalni edem) - otekanje (edem) očesnih vek
Safety of Picato 150 mcg/g treatment for 3 days or Picato 500 mcg/g treatment for 2 days was assessed up to day 57, the majority of the reported adverse reactions and local skin responses were mild to moderate in intensity and all resolved without sequelae.
Picato 500 µg/g so proučevali 57 dni, pri čemer je bilo ugotovljeno, da je večina poročanih neželenih učinkov in lokalnih reakcij na koži blage ali zmerne intenzivnosti ter, da so izzveneli brez posledic.
- Do not cover the treated area with air- or water-tight bandages after you have applied this medicine.
- Zdravljenega mesta, na katerega ste nanesli to zdravilo, ne prekrivajte z obliži, neprepustnimi za zrak ali vodo.
Vehicle (n=20)
Vehikel (n = 20)
In a double-blind, vehicle-controlled study in patients with AK on trunk and extremities, an investigational product with ingenol mebutate gel 600 mcg/g was applied once daily for 2, 3, or 4 days to a skin area of 250 cm2.
V dvojno slepi, z vehiklom nadzorovani študiji, so pri bolnikih z aktinično keratozo na trupu in okončinah preiskovano zdravilo, gel z ingenolmebutatom 600 µg/g, nanašali 2, 3 ali 4 dni na predel kože velikosti 250 cm2.
One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate) should be applied once daily to the affected area for 3 consecutive days.
Eno tubo zdravila Picato 150 µg/g gel (ki vsebuje 70 µg ingenolmebutata) je treba enkrat dnevno nanesti na prizadeti predel in postopek ponavljati 3 zaporedne dni.
If you are treating your hands you should only wash the fingertip which you used for applying the gel.
Če izvajate zdravljenje na rokah, umijte samo blazinico prsta, s katerim ste nanašali gel.
If you are breast-feeding, avoid physical contact between the baby and the treated area for 6 hours after application of this medicine.
Če dojite, 6 ur po nanosu tega zdravila preprečite telesni stik dojenčka z mestom zdravljenja.
Other side effects: - Eye pain - Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
Drugi neželeni učinki: - bolečina v očesu - poškodba ali draženje površine očesa (roženice, veznice) po nenamerni izpostavljenosti
Drink plenty of water if you accidentally swallow this medicine and seek medical assistance.
Ob nenamernem zaužitju pijte veliko vode in poiščite zdravniško pomoč.
Complete Clearance
Popolna ozdravitev
Talk to your doctor or pharmacist before using Picato.
Pred začetkom uporabe zdravila Picato se posvetujte z zdravnikom ali farmacevtom.
Picato 500 micrograms/g gel ingenol mebutate
Picato 500 mikrogramov/g gel ingenoli mebutas
Vehicle (n=270)
Vehikel (n = 270)
Vehicle (n=232 )
Vehikel (n = 232)
Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each.
Zdravilo Picato 150 µg/g gel je pakirano v škatli s 3 tubami, od katerih vsaka vsebuje 0,47 g gela.
Picato 150 mcg/g (n=277 )
Zdravilo Picato 150 µg/g (n = 277)
In a double blind, vehicle-controlled study, up to two treatment courses of Picato 150 mcg/g were administered to 450 patients with 4-8 AKs in a 25 cm2 treatment area on the face or scalp.
V dvojno slepi, z vehiklom nadzorovani študiji je 450 bolnikov s 4-8 aktiničnimi keratozami na predelu obraza in lasišča v velikosti 25 cm2 prejelo do dva cikla zdravljenja z zdravilom Picato 150 µg/g.
Picato 150 micrograms/g gel ingenol mebutate
Picato 150 mikrogramov/g gel ingenoli mebutas
Picato 500 mcg/g (n=226 )
Zdravilo Picato 500 µg/g (n = 226)
Long-term follow up
Dolgotrajno sledenje
Picato 500 mcg/g gel is available in a carton containing 2 tubes with 0.47 g of gel each.
Zdravilo Picato 500 µg/g gel je pakirano v škatli z 2 tubama, od katerih vsaka vsebuje 0,47 g gela.
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO
Scientific conclusions
KLINIČNI PODATKI
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 500 mcg/g GEL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S TUBAMI 500 mikrogramov/g GEL
On the treatment area: - Itching (pruritus) - Irritation
Na zdravljenem mestu: - srbenje (pruritus) - draženje
- Warmth
- draženje
Picato 150 mcg/g gel (n= 92)
Picato 150 µg/g gel (n = 92)
On the treatment area: - Tingling or numbness (paraesthesia) - Open sores (ulcer) - Discharge (secretion) of fluid - Change in skin colour (pigmentation change)
- odprte rane (razjede) - izloček (sekrecija) - sprememba barve kože (pigmentacijska sprememba)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 150 mcg/g GEL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S TUBAMI 150 mikrogramov/g GEL
Likewise the efficacy and safety of Picato 500 mcg/g, administered on the trunk and extremities for 2 consecutive days was studied in two double-blind, vehicle-controlled, clinical studies including 458 adult patients.
Tudi učinkovitost in varnost zdravila Picato 500 µg/g, ki se je 2 zaporedna dneva uporabljalo na trupu ali okončinah, so proučili v dveh dvojno slepih kliničnih študijah,
Trunk and extremities
Trup in okončine
Avoid touching the treatment area for 6 hours after applying your medicine.
6 ur po nanosu zdravila se ne dotikajte zdravljenega mesta, na katerega ste nanesli zdravilo.
Wash your hands again if you happen to touch the area where you applied the gel.
Če se za tem dotaknete predela, na katerega ste nanesli gel, si znova umijte roke.
Other possible side effects when treating the trunk and extremities: Common side effects, may affect up to 1 in 10 people:
Drugi možni neželeni učinki ob zdravljenju trupa in okončin: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
Wash your hands thoroughly after you have applied the gel.
Po nanašnju gela si temeljito umijte roke.
On the treatment area: - Some of the outer layer of your skin may wear away (erosion) - Blisters (vesicles, pustules) - Peeling (exfoliation) - Scabs - Redness due to widening of the small blood vessels (erythema)
Na zdravljenem mestu: - lahko se odlušči del vrhnje plasti kože (erozija) - mehurji (vezikule in pustule)
Headache
- glavobol
- Gently rub the gel onto the treatment area.
- Gel nežno vtrite v prizadeto mesto.
Infection at the application site has been reported when treating face and scalp.
Pri zdravljenju obraza in lasišča so poročali o okužbi na mestu nanosa.
Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
Vsaka tuba vsebuje 235 mikrogramov ingenolmebutata v 0,47 g gela.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Picato 150 mcg/g gel (n=42)
Picato 150 µg/g gel (n = 42)
Picato 500 mcg/g was well tolerated when applied to a contiguous treatment area of 100 cm2 on the trunk and extremities.
Zdravilo Picato 500 µg/g so bolniki pri nanosu na sklenjeno prizadeto mesto velikosti 100 cm2 na trupu in okončinah dobro prenašali.
Name and address of the manufacturer responsible for batch release LEO Laboratories Ltd.
Ime in naslov izdelovalca, odgovornega za sproščanje serij
These side effects most often occur within one day after applying this medicine.
Ti neželeni učinki se navadno pojavijo 1. dan po nanosu zdravila.
Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
Vsaka tuba vsebuje 70 mikrogramov ingenolmebutata v 0,47 g gela.
Application site erosion
Stopnja delne ozdravitveb
Other possible side effects when treating the face and scalp: Common side effects, may affect up to 1 in 10 people:
Drugi možni neželeni učinki ob zdravljenju na obrazu in lasišču: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
Posology
Obraz
Lesion Based Recurrence Rateb 12 months
Stopnja ponovitve pri 12 mesecih ocena KM (95-odstotni IZ)a Stopnja ponovitve lezijb 12 mesecev
Each tube contains 70 mcg of ingenol mebutate in 0.47 g of gel.
Vsaka tuba vsebuje 70 µg ingenolmebutata (ingenoli mebutas) v 0,47 g gela.
Each gram of gel contains 150 micrograms of ingenol mebutate.
En gram gela vsebuje 150 mikrogramov ingenolmebutata.
Each gram of gel contains 500 micrograms of ingenol mebutate.
En gram gela vsebuje 500 mikrogramov ingenolmebutata.
Each tube contains 235 mcg of ingenol mebutate in 0.47 g of gel.
Vsaka tuba vsebuje 235 µg ingenolmebutata (ingenoli mebutas) v 0,47 g gela.
Please contact your doctor or pharmacist if you forget to use Picato.
Če ste pozabili uporabiti zdravilo Picato Če ste pozabili uporabiti zdravilo Picato, se posvetujte s svojim zdravnikom ali farmacevtom.
LIST OF EXCIPIENTS
- izloček (sekrecija)
- Wash your hands with soap and water immediately after applying the gel, and also in between administrations if prescribed two different strengths for two different areas.
- Po nanosu gela in med lokalnimi nanosi, če je treba na dveh različnih mestih uporabiti različne jakosti gela, si nemudoma umijte roke z milom in vodo.
If more than half of the treatment area is located in the upper part of the neck: - Use Picato 150 mcg/g gel (face and scalp) If more than half of the treatment area is located in the lower part of the neck: - Use Picato 500 mcg/g gel (trunk and extremities)
Če je več kot polovica zdravljenega mesta na spodnjem delu vratu, je treba uporabiti gel Picato 500 μg/g v odmerku za trup in okončine.
Actinic keratosis on the trunk and extremities in adults One tube of Picato 500 mcg/g gel (containing 235 mcg ingenol mebutate) should be applied once daily to the affected area for 2 consecutive days.
Eno tubo zdravila Picato 500 µg/g gel (ki vsebuje 235 µg ingenolmebutata) je treba enkrat dnevno nanesti na prizadeti predel in postopek ponavljati 2 zaporedna dneva.
No systemic absorption was detected at or above the lower limit of detection (0.1 ng/mL) when Picato 500 mcg/g from 4 tubes was applied to an area of 100 cm2 on the dorsal forearm in actinic keratosis patients once daily for 2 consecutive days.
100 cm2 na hrbtni strani podlahti pri bolnikih z aktinično keratozo niso opazili sistemske absorpcije na meji zaznavnosti ali nad njo (0,1 ng/ml).
OTHER
Zaužitje
Each gram of gel contains 150 mcg of ingenol mebutate.
En gram gela vsebuje 150 µg ingenolmebutata (ingenoli mebutas).
Chest
Lasišče
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Application site infection
Ponovitev na zdravljenem predelud
29 August 2014
29. avgusta 2014
Within 3 months after EC decision
V roku 3 mesecev po odločbi ES
Outline of the education materials within 3 months after EC decision
Povzetek izobraževalnega gradiva v roku 3 mesecev od odločbe ES
Conditions to the marketing authorisations
Pogoji dovoljenj za promet z zdravili
National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojne nacionalne agencije ene ali več držav članic ali referenčnih držav članic bodo zagotovile, kjer je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
This will be included in the risk management plan, highlighting the risks and warnings of thromboembolism (by e.g. a checklist, to be implemented at national level).
Gradivo bo vključeno v načrt za obvladovanje tveganja in bo opozarjalo na tveganja in simptome, povezane s trombembolijo (npr. kontrolni seznam, ki se bo uporabljal na nacionalni ravni).
The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Imetnik(i) dovoljenja za promet mora(jo) v okviru RMP predložiti protokol za študijo uporabe zdravila, namenjeno razjasnitvi prakse pri predpisovanju zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo zdravila, in opredelitvi glavnih razlogov za predpisovanje.
The MAH(s) should submit the next PSUR by:
Imetnik(i) dovoljenja za promet mora(jo) naslednji PSUR predložiti do:
The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Imetnik(i) dovoljenja za promet mora(jo) predložiti ključne dele (vključno s študijo uporabe zdravila, študijo PASS in izobraževalnim gradivom) načrta za obvladovanje tveganja v formatu EU.
The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Imetnik(i) dovoljenja za promet mora(jo) v okviru načrta za obvladovanje tveganja predložiti protokol študije PASS, namenjene oceni učinkovitosti dejavnosti za zmanjšanje tveganja.
The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Imetnik(i) dovoljenja za promet mora(jo) v okviru načrta za obvladovanje tveganja predložiti izobraževalno gradivo za zdravstvene delavce, ki bodo predpisovali zdravilo, in bolnice.
This summary was last updated on 12-2017.
Povzetek je bil nazadnje posodobljen 12-2017.
In addition, the company will report on the 5-year survival rates of patients who took part in studies.
Poleg tega bo poročala o petletnih stopnjah preživetja bolnikov, ki so bili udeleženi v študijah.
However, more data are needed to fully understand the medicine's effectiveness.
Vendar je za celovitejše razumevanje učinkovitosti zdravila potrebnih več podatkov.
Each course of treatment with the medicine is given for 5 or 10 days every 35 days.
Vsak cikel zdravljenja z zdravilom poteka od 5 do 10 dni in se ponovi vsakih 35 dni.
It must be given in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if needed.
Dajati ga je treba v bolnišnici, in sicer ga mora dajati zdravnik ali medicinska sestra, ki lahko obvlada hude alergijske reakcije in ima po potrebi takoj na voljo opremo za oživljanje.
The company will also perform tests to obtain more information on how the medicine is processed by the body and how the immune system responds to the medicine.
Prav tako bo izvajala preiskave, s katerimi bo pridobila več informacij o tem, kako se zdravilo presnavlja v telesu in kako se imunski sistem odziva nanj.
Treatment must be supervised by a doctor experienced in the treatment of cancer.
Zdravljenje z zdravilom Qarziba mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
It is used in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back):
Uporablja se pri dveh skupinah bolnikov, ki imajo nevroblastom z visokim tveganjem (z veliko verjetnostjo za ponovitev):
Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
At the start of treatment some of these patients had no sign of neuroblastoma and some still had some sign of the disease.
Na začetku zdravljenja nekateri od teh bolnikov niso imeli znakov nevroblastoma, drugi pa so še vedno imeli znake bolezni.
Qarziba has been authorised under ‘exceptional circumstances'.
Zdravilo Qarziba je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
• patients who have had some improvement with previous treatments, which included blood stem cell transplantation (a transplant of blood-producing cells);
• pri bolnikih, pri katerih je s predhodnimi načini zdravljenja, vključno s presaditvijo krvnih matičnih celic (presaditvijo krvotvornih celic), prišlo do delnega izboljšanja;
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da obstaja pomanjkanje možnosti zdravljenja za preprečevanje ponovitve nevroblastoma z visokim tveganjem.
The summary of the opinion of the Committee for Orphan Medicinal Products for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Qarziba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The doctor may need to reduce or delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Zdravnik bo morda moral odmerek zmanjšati ali počakati z naslednjimi odmerki, če se pojavijo nekateri neželeni učinki, ali popolnoma prekiniti zdravljenje, če so neželeni učinki hudi.