natgillin/translations-raw huggingface dataset:
--------------------------------------------------------------------------------------------------------------------------- -- The following information is intended for medical or healthcare professionals only:
----------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
Vials Gadovist should not be drawn up into the syringe from the vial until immediately before use.
Viale Zdravilo Gadovist smete povleči iz viale v injekcijsko brizgo šele tik pred uporabo.
Gadovist 1.0 mmol/ ml, solution for injection, prefilled syringe
Gadovist 1, 0 mmol/ ml raztopina za injiciranje v napolnjeni injekcijski brizgi
- If you have any further questions, please ask your doctor or the person giving you Gadovist
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali osebo, ki vam daje zdravilo Gadovist
Gadovist (see “ What Gadovist contains”).
vsebuje zdravilo Gadovist ").
- If you are younger than 18, use of Gadovist is not recommended.
- Če ste mlajši od 18 let, uporaba zdravila Gadovist ni priporočena.
Important information about some of the ingredients of X This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i. e. essentially ‘ sodium-free’.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek (na podlagi povprečne količine, ki se daje osebi, ki tehta 70 kg), kar v bistvu pomeni "brez natrija".
Rare
39 Neželeni učinki, ki so jih opazili v kliničnih preskušanjih pred odobritvijo uporabe zdravila Gadovist:
Austria Belgium Denmark Finland France Germany Greece Ireland Italy Luxembourg Netherlands Norway Portugal Spain Sweden United Kingdom
Belgija Danska Finska Francija Nemčija Grčija Irska Italija Luksemburg Nizozemska Norveška Portugalska Španija Švedska Velika Britanija
Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist
Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist Gadovist
This leaflet was last approved in {MM/ YYYY}. [To be completed nationally]
[Izpolni država članica]
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Powder for solution for infusion
prašek za raztopino za infundiranje intravenska
Eli Lilly Ges. m. b. H Kölblgasse 8-10 1030 Wien Austria
Eli Lilly Ges. m. b. H Kölblgasse 8- 10 1030 Wien Avstrija
Rue De L'Etuve 52 B-1000 Brussels Belgium
Rue De L' Etuve 52 B- 1000 Brussels Belgija
Eli Lilly Nederland B. V., Grootslag 1-5, 3991 RA Houten The Netherlands
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA Houten Nizozemska
Eli Lilly Č R, s. r. o, Pobř ež ní 1A, 186 00 Praha 8 Czech Republic
Eli Lilly ČR, s. r. o, Pobřežní 1A, 186 00 Praha 8 Češka republika
Eli Lilly Č R, s. r. o, Pobř ež ní 1A,, 186 00 Praha 8 Czech Republic
Eli Lilly ČR, s. r. o, Pobřežní 1A,, 186 00 Praha 8 Češka republika
2 Cyprus
2 Ciper
PHADISCO LTD 185 Giannou Kranidioti Avenue CY-2234 Latsia Cyprus
PHADISCO LTD 185 Giannou Kranidioti Avenue CY- 2234 Latsia Ciper
Eli Lilly Danmark A/ S, Nybrovej 110, DK-2800 Kongens Lyngby Denmark
Eli Lilly Danmark A/ S, Nybrovej 110, DK- 2800 Kongens Lyngby Danska
Kingsclere Road, Basingstoke, Hampshire, RG21 6XA United Kingdom
Kingsclere Road, Basingstoke, Hampshire RG21 6XA Velika Britanija
Estonia
uporaba
Eli Lilly Holdings Linited, Kingsclere Road, Basingstoke, Hampshire, RG21 6XA United Kingdom
Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA Velika Britanija
Oy Eli Lilly Finland, Ab Rajatorpantie 41 C, PL 16, 01641 Vantaa Finland
Oy Eli Lilly Finland, Ab Rajatorpantie 41 C, PL 16, 01641 Vantaa Finska
LILLY France SAS
LILLY France SAS 13, rue Pagès 92158 Suresnes Cedex Francija
GEMZAR
GEMZAR 1000 mg, poudre pour 1000 solution pour perfusion
1000 mg, poudre 1000 mg
mg
Lilly Deutschland GmbH Teichweg 3 35396 Gießen Germany
Lilly Deutschland GmbH Teichweg 3 35396 Gießen Nemčija
FARMASERVE LILLY S. A. Cl 15 Km National Road Athens-Lamia Kifissia, 14564 Greece
FARMASERVE LILLY S. A. Cl 15 Km National Road Athens- Lamia Kifissia, 14564 Grčija
FARMASERVE LILLY S.A.Cl 15 Km National Road Athens-Lamia Kifissia, 14564 Greece
FARMASERVE LILLY S. A. Cl 15 Km National Road Athens- Lamia Kifissia, 14564 Grčija
Eli Lilly Nederland BV PO Box 379 3990 GD Houten The Netherlands
Eli Lilly Nederland BV PO Box 379 3990 GD Houten Nizozemska
Gemzar 1g powder for injection
Gemzar
1g
1g powder for injection 1g
Powder for Injection
prašek za injiciranje
4 Ireland
4 Irska
Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL United Kingdom
Eli Lilly and Company Limited
Gemzar 200 mg powder for solution for infusion
200 mg powder for 200 mg
200mg
prašek za raztopino za infundiranje intravenska
Powder for solution for infusion
Lilly House, Priestley Road,, Basingstoke, Hampshire RG24 9NL.
Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL United Kingdom
Velika Britanija
Eli Lilly Denmark, Nybrovej 110, 2800 Lyngby Denmark
Eli Lilly Denmark, Nybrovej 110, 2800 Lyngby Danska
Via Gramsci 731/733 - 50019 Sesto Fiorentino, Florence Italy
Via Gramsci 731/ 733 - 50019 Sesto Fiorentino, Florence Italija
Powder for solution for infusion and intravesical instillation
prašek za raztopino za infundiranje in intravezikalno vstavitev
Intravenous use and intravesical use
intravenska uporaba in intravezikalna uporaba
Intravenous use and intravesical use
intravenska uporaba and intravesical use
Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke, Hampshire, RG 216XA5 United Kingdom
Eli Lilly Holdings Limited, Kingsclere Road, Basingstoke, Hampshire, RG 216XA5 Velika Britanija
5 Latvia
5 Latvija
Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA United Kingdom
Eli Lilly Holdings Limited Kingsclere Road, Basingstoke, Hampshire RG21 6XA Velika Britanija
52, rue de l'Etuve B-1000 Bruxelles Belgium
52, rue de l' Etuve B- 1000 Bruxelles Belgija
6 The Netherlands
Nizozemska
Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten The Netherlands
Eli Lilly Nederland BV Grootslag 1- 5 3991 RA Houten Nizozemska
Eli Lilly Netherlands BV Grootslag 1-5 3991 RA Houten The Netherlands
Eli Lilly Netherlands BV Grootslag 1- 5 3991 RA Houten Nizozemska
Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norway
Eli Lilly Norge AS, Postboks 6090 Etterstad, N- 0601 Oslo Norveška
2 rue du colonel Lilly 67642 Fegersheim France
2 rue du colonel Lilly 67642 Fegersheim Francija
Portugal
7 Portugalska
António Loureiro Borges, 1 - Piso 1 - Arquiparque - Miraflores 1499- 016 Algés Portugal
António Loureiro Borges, 1 - Piso 1 - Arquiparque - Miraflores 1499- 016 Algés Portugalska
7 Portugal
Portugalska
Lilly France S.A.S 2 Rue du Colonel Lilly 6740 Fegersheim France
Lilly France S. A. S 2 Rue du Colonel Lilly 6740 Fegersheim Francija
Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Czech Republic
Eli Lilly ČR, s. r. o., Pobřežní 1a, 186 00 Praha 8 Češka republika
Dunajska 156 1000 Ljubljana Slovenia
Dunajska 156 1000 Ljubljana Slovenija
Slovenia
uporaba
Lilly, S.A., Avenida de la Industria, 30 28108 Alcobendas Madrid Spain
Lilly, S. A., Avenida de la Industria, 30 28108 Alcobendas Madrid Španija
Powder for solution for injection
prašek za raztopino za infundiranje
8 Sweden
Švedska
Eli Lilly Sweden AB Box 721 169 27 Solna Sweden
Eli Lilly Sweden AB Box 721 169 27 Solna Švedska
Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL United Kingdom
Eli Lilly and Company Limited Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL Velika Britanija
Gemzar 200 mg Powder for Solution for Infusion
200 mg
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Gemzar was included in the list of products for SPC harmonisation, in accordance with Article 30(2) of Directive 2001/83/EC, as amended because of the divergences existing amongst the nationally authorised SPCs due to the divergent national decisions taken by Member States.
Zdravilo Gemzar je bilo vključeno na seznam zdravil, pri katerih je potrebno uskladiti povzetke glavnih značilnosti zdravila v skladu s členom 30( 2) Direktive 2001/ 83/ ES, kakor je bila spremenjena, ker so se na državnih ravneh odobreni povzetki glavnih značilnosti zdravila razhajali zaradi razlik v odločitvah držav članic.
Gemcitabine (difluoro- deoxy-cytidine (dFdC)) is a cytotoxic anti-cancer agent, which exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells through the G 1/S phase boundary.
Gemcitabin (difluoro deoksicitidin (dFdC)) je citotoksično sredstvo proti raku, ki kaže specifičnost do faze celice in v prvi vrsti uničuje celice, v katerih ravnokar poteka sinteza DNK (faza S), ter pod določenimi pogoji blokira prestop celice preko meje med fazama G1 in S.
The following indications are currently approved for Gemzar and were assessed by the CHMP:
Za zdravilo Gemzar so trenutno odobrene naslednje indikacije, ki jih je ovrednotil tudi CHMP:
1) Bladder cancer, 2) Advanced Non- small cell lung cancer, 3) Advanced pancreatic cancer, 4) Breast cancer and 5) Ovarian cancer.
1) rak mehurja, 2) napredovali nedrobnocelični pljučni rak, 3) napredovali rak trebušne slinavke, 4) rak dojk in 5) rak jajčnikov.
For the indication in bladder cancer, the MAH provided data from two Phase 2 studies and from a pivotal Phase 3, showing that gemcitabine chemotherapy is active, tolerable, displays manageable toxicity and superiority to MVAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy in the treatment of patients with advanced or metastatic transitional cell carcinoma of the urothelium.
Za indikacijo raka sečnega mehurja je imetnik dovoljenja za promet z zdravilom predstavil dve študiji II. faze in iz ključne študije III. faze, ter tako pokazal, da je kemoterapija z gemcitabinom aktivna, jo bolniki lahko prenašajo, kaže obvladljivo toksičnost ter učinkuje bolje kot kemoterapija z MVAC (metotreksat, vinblastin, adriamicin in cisplantin) pri zdravljenju bolnikov z napredovalim ali metastatskim karcinomom prehodnih celic urotelija.
The CHMP required the MAH to reflect the target population (patients with advanced/metastatic bladder cancer) and the combination treatment with cisplatin in the harmonized indication.
CHMP je imetniku dovoljenja za promet z zdravilom naložil, naj usklajena indikacija odraža ciljno populacijo (bolniki z napredovalim/ metastatskim rakom sečnega mehurja) in kombinacijsko zdravljenje s cisplatinom.
“Gemcitabine is indicated in the treatment of locally advance or metastatic bladder cancer in combination with cisplatin.”.
„ Gemcitabin je indiciran za zdravljenje lokalno napredovalega ali metastatskega raka sečnega mehurja v kombinaciji s cisplantinom. “
Intravenous gemcitabine has become widely accepted as the standard of chemotherapy care for advanced pancreatic cancer but has yielded disappointing results as combination treatment in patients with locally advanced (nonresectable) or metastatic pancreatic cancer and the MAH considered that gemcitabine monotherapy remains the standard of chemotherapy care for advanced/metastatic, nonresectable pancreatic adenocarcinoma.
Intravenska uporaba gemcitabina je postala široko sprejeta kot standard kemoterapijske nege bolnikov z napredovalim rakom trebušne slinavke, vendar so rezultati take uporabe pri kombinacijskemu zdravljenju bolnikov z lokalno napredovalim (ki ga ni mogoče odstraniti kirurško) ali metastatskim rakom trebušne slinavke razočarali, tako da je imetnik dovoljenja za promet z zdravilom upošteval, da bo ostala
Therefore the CHMP agreed with the proposal but asked the MAH to justify the proposed wording regarding 5-FU refractory patients.
Zaradi tega se je CHMP strinjal s predlogom, vendar je zaprosil imetnika dovoljenja za promet z zdravilom, naj utemelji predlagano besedilo glede neodzivnih bolnikov 5- FU.
11 “Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas”.
„ Gemcitabin je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim adenokarcinomom trebušne slinavke. “
The indication in non-small cell lung cancer is based on data from Phase II and Phase III trials and indicated that gemcitabine has been shown to be active in the treatment of non-small cell lung cancer (NSCLC) and that in addition to gemcitabine single-agent activity, a preponderance of data supports the activity and safety of its combination with cisplatin in the treatment of NSCLC, irrespective of the different doses and schedules.
Indikacija nedrobnocelični pljučni rak temelji na podatkih iz preskusov II. in III. faze in kaže, da so dokazali aktivnost gemcitabina pri zdravljenju nedrobnoceličnega pljučnega raka (NSCLC), poleg aktivnosti samostojnega gemcitabina pa obstaja veliko število podatkov, ki podpirajo aktivnost in varnost kombinacije gemcitabina in cisplatina pri zdravljenju NSCLC, ne glede na različne odmerke in urnike odmerjanja.
The MAH therefore considered the positive benefit-risk ratio to be established for the use of gemcitabine/cisplatin in the treatment of NSCLC.
Imetnik dovoljenja za promet z zdravilom je zaradi tega menil, da je bilo pozitivno razmerje koristi in tveganj uporabe gemcitabina/ cisplatina pri zdravljenju NSCLC dokazano.
The CHMP agreed that gemcitabine used as single agent has shown activity against NSCLC but considered that the combination treatment with gemcitabine + cisplatin is the first line of treatment in patients with advanced/metastatic NSCLC and therefore asked the MAH to further justify the indication of Gemzar as combination treatment and as single agent in NSCLC, bearing in mind that single-agent therapy will usually be restricted to patients with a borderline performance status, elderly patients or pretreated patients.
CHMP se je strinjal, da je uporaba gemcitabina kot samostojnega sredstva pokazala aktivnost proti NSCLC vendar je menil, da je kombinacijsko zdravljenje z gemcitabinom in cisplatinom zdravljenje izbire pri bolnikih z napredovalim/ metastatskim NSCLC, tako da je zaradi tega prosil imetnika dovoljenja za promet z zdravilom, naj nadalje utemelji indikacijo za uporabo zdravila Gemzar za kombinacijsko zdravljenje ter samostojnega sredstva proti NSCLC, pri tem pa naj upošteva, da bo monoterapija s tem zdravilom navadno omejena na bolnike z mejnim statusom učinkovitosti, starostne bolnike ali že zdravljene bolnike.
“Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non small cell lung cancer.
„ Gemcitabin je v kombinaciji s cisplatinom indiciran kot zdravilo v prvi vrsti za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom.
Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.”
Monoterapija z gemcitabinom se lahko uporabi pri starostnih bolnikih ali tistih s statusom učinkovitosti 2. “
Regarding breast cancer, the MAH only proposed combination use for inclusion in the harmonised SPC, although a Phase 3 study showed the activity of single-agent gemcitabine for the treatment of metastatic breast cancer (MBC). The indication was supported by a clinical expert report and efficacy data from Phase 2 and 3 single-agent studies of Gemzar in the treatment of breast cancer, including studies conducted by the MAH and results from the published literature.
Imetnik je indikacijo podprl s poročili kliničnih specialistov in podatki o učinkovitosti iz študij 2. in 3. faze o samostojni uporabi zdravila Gemzar pri zdravljenju raka dojk, vključno s študijami, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, in rezultati iz objavljene literature.
The CHMP was of the opinion that gemcitabine has shown activity as single agent in MBC but the lack of Phase III trials in this setting makes it difficult to give a specific recommendation about the precise place of gemcitabine in the treatment of advance breast cancer.
12 CHMP je bil mnenja, da je gemcitabin izkazal učinkovitost kot samostojno sredstvo proti MBC, vendar pa je pomanjkanje preskusov III. faze otežilo navedbo točno določenih priporočil o natančni vlogi gemcitabina pri zdravljenju napredovalega raka dojk.
Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.
Gemcitabin je v kombinaciji s paklitakselom indiciran za zdravljenje bolnikov z metastatskim ali lokalno ponovljenem rakom oz. rakom, ki ga ni mogoče odstraniti kirurško, pri katerih se je bolezen pojavila znova po zaključeni adjuvantni/ neoadjuvantni kemoterapiji.
Prior chemotherapy should have included an anthracycline unless clinically contraindicated.”
Predhodna kemoterapija mora vključevati antraciklin, razen če to ni klinično kontraindicirano. "
The MAH concluded that the studies demonstrated that gemcitabine plus carboplatin is superior to 12 carboplatin in terms of time to disease progression (TtDP) and response rate in patients with platinum- sensitive recurrent ovarian cancer.
Imetnik dovoljenja za promet z zdravilom je zaključil, da so v študijah dokazali boljši učinek za gemcitabin in karboplatin kot karboplatin v pogledu časa do napredovanja bolezni (TtDP) in mere odziva pri ponovnem pojavu na platino občutljivega raka jajčnikov.
The CHMP reviewed the information regarding the use of Gemcitabine in ovarian cancer and was of the opinion that the combination gemcitabine/carboplatin is an option in second line therapy in patients with sensitive platinum disease and an alternative in patients with previous paclitaxel/carboplatin toxicity (Therefore the CHMP retained the indication in ovarian cancer in the harmonised SPC, with the wording:
CHMP je pregledal informacije o uporabi gemcitabina pri raku jajčnikov in je bil mnenja, da je kombinacija gemcitabina/ karboplatina možnost za zdravljenje druge izbire pri bolnicah, katerih bolezen je občutljiva na platino, in alternativa za bolnice, ki so predhodno pokazale toksične reakcije na paklitaksel/ karboplatin (zaradi tega je CHMP v usklajenem povzetku glavnih značilnosti zdravila obdržal indikacijo za raka jajčnikov, izraženo z besedilom:
“Gemcitabine is indicated in locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence free interval of at least 6 months after-platinum based, first-line therapy”
„ Gemcitabin je indiciran za lokalno napredovali ali metastatski karcinom jajčnikov v kombinaciji s karboplatinom pri bolnicah s ponovitvijo bolezni po obdobju brez bolezni, ki je trajalo vsaj šest mesecev po zdravljenju prve izbire, ki je temeljilo na platini “.
For Section 4.2, the MAH proposed a harmonised wording, addressing in particular the sections about dosage adjustment, about impaired renal function and on precautions in administration.
Imetnik dovoljenja za promet z zdravilom je predlagal uskladitev besedila v poglavju 4. 2, še posebej v podpoglavjih o prilagajanju odmerka, o poslabšanem delovanju ledvic in o varnostnih ukrepih pri dajanju zdravila.
The CHMP retained the conservative age of 18 and also noted that information regarding hepatic impairment was included and therefore requested the MAH to further discuss patients with renal or hepatic impairment and whether severe impairment had significant effect on gemcitabine pharmacokinetics.
CHMP je obdržal konzervativno starost 18 let, poleg tega pa opazil, da so prisotne tudi informacije o okvarjenih jetrih, zaradi česar je od imetnika dovoljenja za
Based on the responses, the CHMP revised the text in section 4.2.
CHMP je besedilo v poglavju 4. 2 pregledal na osnovi teh odgovorov.
For Section 4.3, the MAH proposal retained only two of the existing 8 contraindications (relating to hypersensitivity and breast feeding) and removed 6 (hepatic or renal impairment, cisplatin for patients with severe renal failure, pregnancy and lactation, combination with yellow fever, usage in children and concomitant administration of gemcitabine and radiotherapy).
Predlog imetnika dovoljenja za promet glede poglavja 4. 3 je obdržal le dve od obstoječih osmih kontraindikacij (glede preobčutljivosti in dojenja) ter umaknil ostalih šest (okvara jeter ali ledvic, cisplatin za bolnike s hudo odpovedjo ledvic, nosečnost in dojenje, uporaba pri rumeni mrzlici, uporaba pri otrocih in sočasna uporaba gemcitabina in zdravljenja z obsevanjem).
The CHMP was of the opinion that the MAH proposal was acceptable, but considered that interactions and conditions relevant for all cytotoxics are expected for gemcitabine and that adequate warning should therefore be provided in section 4.4 and 4.5.
CHMP je menil, da je bil predlog imetnika dovoljenja za promet z zdravilom sprejemljiv, vendar je menil, da se za gemcitabin pričakujejo medsebojna delovanja in pogoji, ki so pomembni za vse citotoksike, in da je treba poglavji 4. 4 in 4. 5 opremiti s primernimi opozorili.
For Section 4.4, the MAH addressed impaired renal and hepatic function, paediatric recommendations and concomitant administration of gemcitabine and radiotherapy.
Za poglavje 4. 4 je imetnik dovoljenja za promet z zdravilom obravnaval okvaro jetrne in ledvične funkcije, priporočila za pediatrične bolnike in sočasno uporabo gemcitabina ter zdravljenja z obsevanjem.
In general, the CHMP considered 13 the proposed wording to be adequate, but implemented a number of revisions, including sections on impaired bone-marrow function, combination with carboplatin and cisplatin, live attenuated vaccines and Pharmacovigilance reports on cardiovascular events and viral hepatitis reactivation.
CHMP je v splošnem menil, da je predloženo besedilo primerno, vendar je vnesel številne spremembe, vključno s podpoglavji o okvarjeni funkciji kostnega mozga, kombinaciji s karboplatinom in cisplatinom, živimi cepivi in poročili farmakovigilance o kardiovaskularnih dogodkih in ponovni aktivaciji virusnega hepatitisa.
Sections 4.5, 4.6, 4.7, 4.8 and 4.9 were also harmonised.
Uskladil je tudi poglavja 4. 5, 4. 6, 4. 7, 4. 8 in 4. 9.
For Section 4.8, the CHMP requested the clarification of the presentation of the post-marketing spontaneous report and also proposed a list of revised terms to be used in all the tables of adverse event in combination use in this section.
CHMP je za poglavje 4. 8 zahteval pojasnilo predstavitve spontanih poročil, dobljenih po izdaji na trg, in predlagal seznam popravljenih izrazov, ki naj se jih uporabi v tem poglavju v vseh tabelah neželenih učinkov za kombinacijsko uporabo.
Other sections of the SPC:
Druga poglavja povzetka glavnih značilnosti zdravila:
While the full harmonisation of the quality dossier was not part of the scope of the referral, the sections of the SPC (in particular sections 2 and 6) and the corresponding Package Leaflet sections relating to Quality were assessed and harmonised.
Čeprav popolna uskladitev dosjeja o kakovosti ni bila del napotitvenega postopka, so bila ovrednotena in usklajena poglavja povzetka glavnih značilnosti zdravila (še posebej 2. in 6. poglavje) in ustrezna poglavja navodila za uporabo, ki se nanašajo na kakovost.
In summary the MAH has deleted the indication for intravesical use and for 5-FU- refractory pancreatic cancer while the indication in ovarian cancer has been justified.
Imetnik dovoljenja za promet z zdravilom je torej zbrisal indikacijo za intravezikalno uporabo in za 5- FU neodzivne bolnike z rakom trebušne slinavke, medtem ko je indikacijo za raka jajčnikov uspešno zagovarjal.